Approved Clinical Trials This page provides a searchable list of all clinical trial research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology (UNCST).
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Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
Cissy  Kityo
ID: UNCST-2021-R013663
 Platform Assessing Regimens And Durations In a Global Multisite consortium for TB. A Seamless Phase 2B/2C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis
REFNo: HS3044ES

Phase 2C: Amongst regimens selected for progression from phase 2B, to further evaluate the safety profile and to identify the optimal treatment duration (between 8 and 16 weeks) based on unfavourable outcome to support advancement to future Phase 3 trials.,Phase 2B: To identify regimens with acceptable safety profile that have the greatest potential, based on assessment of quantitative sputum liquid culture and treatment failure/relapse to progress to investigation of optimal treatment duration in Phase 2C.,To identify novel drug regimen(s) with acceptable safety profile, non-inferior efficacy and shortened treatment duration compared to the standard-of-care 24-week HRZE regimen that could be used to treat people with rifampicin susceptible and rifampicin resistant TB.,
 Kampala, Kampala
Wakiso, Kampala
Mukono, Kampala
Mpigi, Mpigi
 Uganda 2023-12-01 17:56:07 2026-12-01 Up to 2500 overall will be enrolled, 700 in phase 2B and 1800 in phase 2C. An estimate of 165 patients in total for Uganda sites (60 in phase 2B and 105 in phase 2C) and about 30 patients for JCRC Lubowa in phase 2B and 55 patients in phase 2C. Adults ≥18 years with newly diagnosed pulmonary TB will be enrolled University College London Medical and Health Sciences Clinical Trial Non-degree Award
Jude Byansi Zziwa
ID:
DEVELOPING A FRAMEWORK FOR PROVIDING SUSTAINABLE SANITATION SERVICES IN URBAN SCHOOLS IN LOW- AND MIDDLE-INCOME COUNTRIES: A CASE OF TWO CITIES IN UGANDA
REFNo: SIR254ES

(iv) To establish the effect of the school centered sanitation service framework on human faecal exposure pathways in urban schools of LMICs.,To ascertain how the key factors in objective (ii) above, interact to provide sustainable sanitation services in city schools,To establish factors sustaining sanitation service provision in city schools,To determine the status of sanitation service provision in city schools ,The general objective of this study is to develop a sanitation management framework that will contribute to sustainable service provision in urban schools of Low- and Middle Income Countries (LMICs).,
 Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
 Uganda 2023-11-20 15:27:51 2026-11-20 2,434 participants The pupil population from age 9 to 25 years, Teacher population from age 23 to 60 years, Other stakeholders will be adults. Male and female participants will be balanced. Citywide Inclusive sanitation Program Engineering and Technology Clinical Trial Degree Award
sunday anziku oyeeson
ID:
Exploring the Teachers’ Feedback Practices and its Influence on Students’ Learning in CBC: A case of a selected secondary school in Central Division, Arua City.
REFNo: SS2007ES

To explore how teachers’ feedback influences students' learning in CBC in lower secondary schools in Arua City.
To find out how students perceive the influence of feedback on their own learning in CBC.
To examine the strategies used by teachers to administer feedback to students in CBC in lower secondary schools in Arua City.
To find out the challenges faced by teachers in administering feedback to students in CBC in lower secondary schools in Arua City.

 Uganda 2023-11-16 13:34:21 2026-11-16 2 school administrators (Headteacher and Deputy), 3 Teachers of lower secondary or CBC classes (S.1, S.2, and S.3) and 9 Students in CBC classes (considering 3 students from each class) The study will be conducted in a secondary school involving CBC class students, teachers and the school administrators Self-Sponsored Social Science and Humanities Clinical Trial Degree Award
Esther Atukunda Cathyln
ID: UNCST-2019-R001701
 Integration of a patient-centered mobile health intervention (Support-Moms) into routine antenatal care to improve maternal health in Uganda.
REFNo: HS3366ES

Evaluate the cost and cost-effectiveness of implementing Support-Moms intervention into routine care and implications for sustainability,Evaluate intervention implementation using the Proctor framework and plan for future scale-up per the Consolidated Framework for Implementation Research ,Test the effectiveness of the Support-Moms intervention in a randomized controlled trial,
 Uganda 2023-11-13 12:57:49 2026-11-13 824 We will include individuals who: 1) are in the first trimester of pregnancy who have not yet presented for ANC, 2) reside in the catchment area of a study HC, 3) are emancipated minors and adults aged ≥ 18 years, 4) report access to a cell phone with reception in their home, 5) are able to identify at least two social supporters living within the study districts, and 6) are able to provide consent. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
 A phase II/III, open-label, randomized clinical trial to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
REFNo: HS3240ES

To assess the time to insert the REBOA.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy is lower in the intervention arm when excluding ‘inevitable’ hysterectomies due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids.,To assess if post-partum haemoglobin concentration is higher in in the intervention arm compared to the comparator arm,To assess if the number of blood transfusion units is lower in the intervention arm compared to the comparator arm.,To assess if the number of participants with acute kidney injury is lower in the intervention arm compared to the comparator arm,To assess if the proportion of participants with maternal deaths is lower in the intervention arm compared to the comparator arm.,To assess if the proportion of participants with emergency hysterectomy, is lower in the intervention arm compared to the comparator arm., To assess the safety of REBOA in a national referral hospital in a low-income country like Uganda.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy, can be decreased from 50 % in the comparator arm (using standard of care alone) to 30 % or less in the intervention arm (using REBOA). ,
 Kampala, Kawempe
 Uganda 2023-11-13 12:15:41 2026-11-13 10 women in phase IIb and 212 women in Phase III (222 IN TOTAL) Women aged 18 and above years and emancipated minors with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg will be recruited Centre For International Health Medical and Health Sciences Clinical Trial Non-degree Award
Stephen Okoboi
ID: UNCST-2019-R001356
 Peer Delivered HIV/Syphilis Self-Testing with Assisted Partner Notification Services for Men who Have Sex with Men (MSM) in Uganda
REFNo: HS3021ES

Estimate the cost-effectiveness of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing.,Conduct a pilot randomized trial to pilot test the preliminary effectiveness of peer delivered HIV/syphilis self-tests and partner services versus facility-based testing., Conduct formative research to inform implementation of peer delivered self-tests for HIV and syphilis with partner services for Ugandan MSM. ,
 Uganda 2023-10-31 19:59:00 2026-10-31 200 Inclusion criteria: In both arms, peers will recruit network members who are 1) aged 18 years and older, 2) Self-report of anal sexual intercourse at least once in the prior quarter 3) self-identify as MSM, 4) not tested in past 3 months or never tested for HIV or syphilis before; 5) willing to provide informed consent; 6) willing to undergo study procedures National Institute of health Medical and Health Sciences Clinical Trial Non-degree Award
Prudence Beinamaryo
ID: UNCST-2023-R007239
 Efficacy of the combination ivermectin and albendazole vs albendazole alone in school-aged children infected with Trichuris trichiura: a randomized controlled trial
REFNo: HS3160ES

To evaluate the safety and tolerability of the ,To determine the CRs and ERRs of the study drugs (i.e. albendazole alone, albendazole-ivermectin) against Ascaris lumbricoides and hookworm in co-infected participants.,To determine the egg reduction rates (ERRs) of ivermectin/albendazole combination therapy compared to albendazole monotherapy against T. trichiura,To demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of CRs against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years.,
 Kabale, Rukore
Kabale, Rukore
 Uganda 2023-10-04 13:42:09 2026-10-04 750 School age children of from Age 6-12 both males and female of any tribe residing in area. Prof. Dr. Jennifer Keiser Medical and Health Sciences Clinical Trial Non-degree Award
Andrew Odur
ID: UNCST-2022-R009128
 A RANDOMIZED CONTROL TRIAL TO DETERMINE THE EFFICACY OF MACHINE LEARNING MODELS TO PREDICT POSTPARTUM HEMORRHAGE
REFNo: HS3132ES

Determine whether earlier knowledge of the high-risk patient likelihood of morbidity can change clinical management to better outcomes,Demonstrate the efficacy of a mobile app prediction-based platform in informing clinical judgment,Determine the suitability of mobile app-based platform integration into the clinical workflow of African obstetricians,Determine the efficacy of ML models to predict the likelihood of pregnancy complications among African mothers,We aim to conduct a randomized control trial to determine the efficacy of machine learning models to predict postpartum hemorrhage to potentially establish a new gold standard way of screening patients in low-resource settings,
 Lira, Cathedral
 Uganda 2023-10-02 15:32:14 2026-10-02 RCT sample size will be 200 The study will enroll pregnant women 18 years and older attending ANC at Lira Regional Referral Hospital intending to deliver from the same facility residing within 10 km distance from the hospital. INFIUSS Health, Inc Medical and Health Sciences Clinical Trial Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
 REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE (REVIVE)
REFNo: HS2892ES

To determine whether azithromycin is effective in reducing the incidence of new infection compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is effective in reducing mortality and hospitalisation at early and late timepoints (4weeks and 24weeks) compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is an effective and safe intervention to reduce excess mortality in adults with advanced HIV (CD4 ≤ 100 cells/mm3). ,
 All Districts, Not applicable
 Uganda 2023-09-27 17:43:49 2026-09-27 8000 18 years and above, all sexes and all tribes Population Health Research Institute (PHRI) Canada Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria.
REFNo: HS2817ES

Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria.
Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
All parts:
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria


 Tororo, Tororo
Tororo, Tororo
 Uganda 2023-09-26 11:55:15 2026-09-26 Part A 12,pART b18 The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Buwembo Rogers
ID: UNCST-2021-R011765
 QUALITY OF SELF-CARE FOR OLDER (AGED 60 YEARS AND ABOVE) PEOPLE WITH DEMENTIA IN WAKISO DISTRICT, UGANDA. CAREGIVER PERCEPTIONS, AND EFFECTS OF A PSYCHOEDUCATION INTERVENTION ON QUALITY OF SELF-CARE.
REFNo: HS2958ES

To determine the effect of a remotely delivered psychoeducation intervention for caregivers of older people with dementia on the quality of self-care.,To explore the perception, caregivers of older people with dementia have towards quality of self-care.,To measure the quality of self-care for older people with dementia in Wakiso district, Uganda.,To Improve quality of self-care provided to older people with dementia through use of a remotely delivered psychoeducation intervention of caregivers of older people with dementia in Wakiso, district Uganda.,
 Wakiso, Kiwenda
 Uganda 2023-09-19 7:51:22 2026-09-19 71 Caregivers of older people diagnosed with dementia, 18-70 years, both female and males, all tribes as applicable Brain Health Training Program Medical and Health Sciences Clinical Trial Degree Award
Edrisa Mutebi Ibrahim
ID:
Safety of JNK61 in Healthy Human Volunteers.
REFNo: HS2474ES

To determine the effect of JNK61 on the blood sugar levels in healthy human volunteers.,To determine the safety of JNK61 in healthy human volunteers,
 Kampala, Makerere University
 Uganda 2023-08-30 16:05:54 2026-08-30 50 Male and female adults of any tribe Government of Uganda through Makerere University Research and Innovations Fund Medical and Health Sciences Clinical Trial Non-degree Award
Joseph  Matovu KB
ID: UNCST-2020-R014654
 Enhancing communication on relationship preservation, safer conception, and pre-exposure prophylaxis (PrEP) to promote HIV testing
REFNo: HS3025ES

Conduct a pilot trial of “PrEPing Healthy Families” with intervention sites implementing the novel communication,Conduct formative research to expand a communication strategy focused on relationship preservation and safer conception into a multi-component intervention with broader reach,To leverage the growing availability of PrEP to determine if and how a communication strategy focused on relationship preservation and safer conception can increase testing and entry into treatment (ART) or prevention (PrEP) among couples in Uganda,
 Mukono, Ntaawo ward
Mityana, Central ward
Butambala, Gombe ward
 Uganda 2023-08-25 8:26:15 2026-08-25 267 The proposed study will recruit up to 267 total participants. These participants include project advisory board members (up to 25) clients in assisted partner notification (APN) or antenatal care (ANC) programs (up to 36 for in-depth interviews [IDIs], up to 150 for exit surveys), their partners (up to 36 for IDIs), and ANC/APN providers at the intervention site (up to 20). Participants will all be aged 18 years and above and all sexes. Glenn Wagner Medical and Health Sciences Clinical Trial Non-degree Award
Mark Kaddumukasa
ID: UNCST-2020-R001798
 SELF MANAGEMENT INTERVENTION FOR REDUCING EPILEPSY BURDEN AMONG UGANDANS WITH EPILEPSY
REFNo: HS2944ES

1. To assess the efficacy of SMART- U vs. eTAU via an RCT.
H1: Individuals randomized to SMART-U will have significantly improved QOL and fewer seizures compared to eTAU.
H2: Individuals randomized to SMART-U will have greater improvement in depression and functional status compared to eTAU.
2. To use short message service (SMS) delivered via mobile phone text to validate patient self-reported seizure occurrence and push epilepsy self-management messaging in a practical/accessible format.
3. To obtain input from stakeholders (patients, family and clinicians) guided by an Integrated Promotion Action on Research Implementation in Health Services (i-PARIHS) framework to help establish sustainable infrastructure that will facilitate future scale up of SMART in Uganda with epilepsy partners

 Kampala, Mulago
Mbarara, Mbarara
 Uganda 2023-08-25 8:11:10 2026-08-25 188 Target population: all adult patients attending the neurology clinic at Mulago and Mbarara hospitals. Accessible population: All adult patients with epilepsy on treatment attending the clinic during the study period. Study population: All adult patients with epilepsy on treatment who will meet the inclusion criteria from all tribes attuning the study clinics. All consecutive adult patients who came either for follow up or as new referrals with confirmed diagnosis of epilepsy were screened for the inclusion into the study. NIH/ USA Medical and Health Sciences Clinical Trial Non-degree Award
Sharon Pang Sze Lu
ID:
Transform Randomised Controlled Trial in Uganda
REFNo: SS1823ES

To evaluate the impact of the Transform program on the key indicators in values, health and livelihood in Uganda
 Hong Kong 2023-08-25 8:07:30 2026-08-25 4800 The study population will include participants aged 18 to 90 years old. Both male and female participants are included in the study. ICM will first choose communities and identify 30 ultra-poor households for its Transform program (administered across control and treatment groups). Eligibility for Transform is determined using poverty assessment via an asset-based scoring and self-reported household income. Historically, there have been an average of 30 households per community. With a target sample size of 160 communities, we will have approximately 4,800 households in the study. ICM targets communities to receive a Transform program based on the proportion of community members living in ultra-poverty (less than USD $0.50/person/day).Participants who are above the threshold using the poverty assessment will be excluded from the study. Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants. International Care Ministries Social Science and Humanities Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 An adaptive, randomized, active-controlled, open-label, sequential cohort, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric participants with severe Plasmodium falciparum malaria (KARISMA – KAE609’s Role In Severe Malaria)
REFNo: HS1980ES

Primary objective
To assess the efficacy of different doses of
intravenous cipargamin vs artesunate by evaluating the proportion of
participants with ? 90% reduction of parasitemia at 12 hours post
administration of the first dose.

Secondary Objectives
1. To assess the presence/absence of severe malaria related individual
signs over time
2. To evaluate parasite clearance dynamics and proportion of participants
with recrudescence and reinfection
3. To assess recovery of participants as measured by time (days and hours)
to discharge from hospital or recovery from prostration
4. To evaluate the safety and tolerability of IV cipargamin
5. To assess the risk of long term neurological sequelae for participants at
Day 29
6. The assess the risk of hemolysis (early and delayed) during the study
duration
7. To characterize the plasma pharmacokinetics of IV cipargamin

 Tororo, Masafu
 Uganda 2023-08-18 9:05:14 2026-08-18 200 patients for AL treatment arm and 100 patients for the other treatment arms per site. At least two drugs will be studied per site The study population will consist of male and female participants, including pediatric participants aged ? 6 months or older. Approximately 252 participants (60 participants of ? 12 years and 192 participants < 12 years) will be randomized Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2748ES

Main Objectives:
1. Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria

Secondary Objectives
1. Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
3. To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
4. To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria
 Uganda 2023-08-10 13:49:44 2026-08-10 14 The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Bernard Kikaire
ID:
Effect of an interactive SMS system in improving the reporting of adverse drug reactions among people living with HIV in Tanzania and Uganda: a randomized controlled trial: The REMIND ADR TRIAL
REFNo: HS2922ES


To investigate the effectiveness of SMS reminders on improving ADR reporting compared to no SMS among people living with HIV in Tanzania and Kampala Uganda.
To describe the most commonly reported ADR profiles among people living with HIV in Tanzania and Uganda.
To determine the most common routes/ methods of reporting ADR used by PLHIV.
To explore the causal relationship between the commonly reported ADRs and ART.
To improve treatment options for participants who reported ADR.
To explore the technical feasibility and acceptability of the intervention in reporting ADR among PLHIV.

 Kampala, mulago
 Uganda 2023-08-08 12:42:32 2026-08-08 114 Age between 18 and 65 confirmed and documented HIV infection Being on ART treatment for less than one year Able to read and understand SMS Able to understand and willing to sign the informed consent document Able to read and write a text message Have a mobile phone The study is funded by Eastern Africa Consortium for Clinical Research (EACCR3) which is a network of excellence under EDCTP Medical and Health Sciences Clinical Trial Non-degree Award
Joseph Lutaakome
ID: UNCST-2020-R008323
 Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE)
REFNo: HS2703ES

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) is a master protocol being conducted in many countries around the world, and funded by the National Institutes of Health, USA. STRIVE will evaluate the safety and effectiveness of unlicensed and licensed treatments and different combinations of treatments, to improve the health outcomes of adults
hospitalised with acute respiratory infections, like COVID-19 or influenza.
 Kampala, Kampala
Masaka, Masaka
Gulu, Gulu
Lira, Lira
 Uganda 2023-08-08 12:39:21 2026-08-08 1,500 The participant population are non-pregnant or breast-feeding adults aged ≥ 18 years; with confirmed COVID-19 for <14 days, and requiring inpatient hospital acute medical care and with evidence of a COVID-19 lower respiratory tract infection. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
 A phase 2, partially-blinded, randomised trial assessing the safety and efficacy of TBAJ876 or bedaquiline, in combination with pretomanid and linezolid in adult participants with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis
REFNo: HS2928ES

The objectives of the trial are to evaluate the efficacy, safety, and tolerability of TBAJ876 (3 doses) or bedaquiline in combination with pretomanid and linezolid in adult participants with newly diagnosed, smear-positive pulmonary DS-TB in comparison to the SOC
 Kampala, Mulago
Kampala, Lubowa
 Uganda 2023-08-07 15:20:08 2026-08-07 The trial is planned to randomise at least 60 participants per treatment arm, for a total of at least 300 participants randomised. Study population should have the following characteristics: 1. Signed written informed consent prior to undertaking any trial-related procedures. 2. Participants aged 18 to 65 years, inclusive. 3. Body weight (in light clothing and no shoes) ≥35 kg. 4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale on smear microscopy) at the trial laboratory. 5. DS-TB participants defined as the following: a. Sensitive to rifampicin and isoniazid by rapid sputum-based test (see trial Mycobacteriology Laboratory Manual) AND b. Either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB. 6. A chest x-ray during the screening period or within 14 days of screening which in the opinion of the investigator is compatible with pulmonary TB. 7. Be of non-childbearing potential OR using effective methods of birth control as defined below: Non-childbearing Potential a. Participant is not heterosexually active or practices sexual abstinence OR b. Female participant or male participant’s female sexual partner: bilateral oophorectomy, bilateral tubal ligation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months OR c. Male participant or female participant’s male sexual partner: vasectomized or has had a bilateral orchidectomy at least 3 months prior to screening Effective method of birth control is defined as 1 of the following: a. Double-barrier method which can include a combination of male condom, diaphragm, cervical cap, or female condom. Note: Female and male condom should not be used together. b. Combination of a barrier method with hormone-based contraceptives or an intrauterine device. Both male and female participants must be willing to continue practicing birth control methods and not be planning to conceive throughout treatment and for 6 months after the last dose of IMP. References to male or female mean “assigned male or female at birth,” respectively. TB Alliance Medical and Health Sciences Clinical Trial Non-degree Award
Proscovia Nabunya
ID: UNCST-2019-R000970
 Say No to Stigma-Round 2: Pilot testing the impact of visuals designed to reduce mental health stigma among primary school students in Uganda
REFNo: SS1818ES

Examine the acceptability and preliminary impact of the Say No to Stigma visual solutions on children’s mental health awareness and stigma in schools.
 Uganda 2023-07-27 20:55:02 2026-07-27 100 One hundred (100) students in total will be recruited for this study. Inclusion Criteria: Children: 1) ages between 8 to 13 (primary 2 to 7) enrolled in the selected school. Exclusion Criteria: 1) inability to comprehend study procedures or participant rights as assessed by trained staff during the informed consent process; or 2) they are unwilling or unable to commit to completing the study. Washington University in St. Louis Social Science and Humanities Clinical Trial Non-degree Award
Grace Mirembe
ID: UNCST-2022-R008850
 RV 591 entitled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults”
REFNo: HS2891ES

To assess the safety, reactogenicity and tolerability of two vaccination regimens: rapid dose-escalation of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV or co-administration of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV
 Kampala, Central
 Uganda 2023-07-14 9:49:16 2026-07-14 50 Healthy male and female participants, aged 18 to 50 years The Surgeon General, Department of the Army Medical and Health Sciences Clinical Trial Non-degree Award
Joy Gumikiriza- Onoria Louise
ID:
Development of a Caregiver Centered Psychotherapy (CCPT) in addressing patient care for older persons with Alzheimer’s Disease and Related Dementias (ADRD) in Uganda.
REFNo: HS2909ES

1. To explore ways in which older people in the community of Wakiso district conceptualize ADRD and what informs their opinions. 2. To assess caregiver distress, non-professional techniques of patient care, quality of life and the associated factors among family caregivers of persons with ADRD in Wakiso district.To adapt and pre-test the WHO-iSupport for family caregivers of persons with ADRD in Wakiso, Uganda4. To determine the effectiveness of A-iSupport in the alleviation of distress among family caregivers of persons with ADRD in Wakiso, Uganda
 Wakiso, Busukuma
Wakiso, Nansana
 Uganda 2023-07-14 9:40:03 2026-07-14 180 All residents of Wakiso district aged 60 years and older, includidng caregivers of persons with ADRD BRAIN health Medical and Health Sciences Clinical Trial Degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO-TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER (HeredERA)
REFNo: HS2968ES

To identify and/or evaluate biomarkers that are predictive of response to Phesgo and giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to Phesgo and giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of Phesgo and giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety,To evaluate potential effects of ADAs,To evaluate the immune response to pertuzumab, trastuzumab, and rHuPH20,To evaluate the potential relationships between Phesgo and giredestrant exposure and the safety, efficacy, immunogenicity, or biomarker endpoints.,To characterize the giredestrant, pertuzumab, and trastuzumab PK profile when given in combination,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo from the participant's perspective,To evaluate health utility of participants treated with Phesgo plus giredestrant compared with Phesgo to generate utility scores for use in economic models,To evaluate effects of Phesgo plus giredestrant compared with Phesgo on work productivity and activity,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo,To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo,
 Kampala, Mulago
 Uganda 2023-07-14 12:43:26 2026-07-14 20 This study will enrol patients with locally advanced or metastatic receptor positive breast cancer above 18 years of age La Roche Hoffman Medical and Health Sciences Clinical Trial Non-degree Award
Angella Natukunda
ID:
DETERMINANTS OF NUTRITION STATUS AMONG ADOLESCENTS IN SELECTED SECONDARY SCHOOLS OF KANUNGU DISTRICT SOUTH WEST REGION UGANDA
REFNo: SS1812ES

Broad obective To investigate the determinants of nutrition status among adolescents in selected secondary schools in Kanungu District South West Uganda. Specific objectives To assess the nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the social demographic and economic factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the diet-related factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the level of adolescent nutrition knowledge associated with nutrition status among adolescents in the selected secondary schools of Kanungu District South West Region Uganda.
Uganda 2023-07-14 12:34:44 2026-07-14 370 The study population will constitute of adolescents both male and female studying in secondary schools of Kanungu district 12 to 19 years. Natukunda Angella Social Science and Humanities Clinical Trial Degree Award
Rhoda Wanyenze
ID: UNCST-2021-R013352
 A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention (GC-CCP) in Uganda
REFNo: SS1873ES

1. Conduct a multisite RCT of the GC-CCP network-based advocacy strategy to evaluate effects on CC screening uptake, access to early-stage treatment and prevention of advanced disease among unscreened alters across urban/rural and public/private clinics,4. Evaluate the cost-effectiveness of Implementing GC-CCP to increase CC screening and low cost, early-stage treatment, and prevent advanced disease, compared to enhanced usual care.,3. Examine mediators and moderators (among index, alter and network characteristics) of intervention effects on (a) alter CC screening; and (b) engagement in CC prevention advocacy of index and alter (1st and 2nd degree) to better understand its multiplier effect on diffusion of advocacy throughout a network.,2. Use a mixed methods approach (semi-structured interviews and administrative clinic data) to examine clinic-, provider-, and client-level barriers and facilitators of GC-CCP Implementation and Sustainment.,
 Kampala, Nsambya
Kampala, Kawempe
Buikwe, Buikwe
Kayunga, Kayunga
 Uganda 2023-07-13 11:13:19 2026-07-13 1400 women Women recently screened for Cancer of the Cervix and aged 25 years and above will be enrolled as index participants, Women who have not screened for Cancer of the Cervix but are network members of index participants will be enrolled as alter participants, Clinic leadership and providers of Cervical Cancer services will participate in qualitative interviews. National Institute of Mental Health Social Science and Humanities Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (Lidera)
REFNo: HS2193ES

Main Objective

1. To demonstrate superiority of giredestrant over the control treatment.
Specific Objectives

1. To evaluate the efficacy of giredestrant compared with Therapy of Physician's Choice
2. To evaluate the safety of giredestrant compared with Therapy of Physician's Choice
3. To characterize giredestrant Pharmacokinetics
4. To evaluate health status utility scores of participants treated with giredestrant compared with Therapy of Physician's Choice
5. To evaluate the tolerability of giredestrant compared with Therapy of Physician's Choice
6. To identify and/or evaluate biomarkers that are predictive of response to giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety
 Kampala, Mulago
Uganda 2023-07-13 10:07:44 2026-07-13 18 women aged 18 years of age and over with histologically confirmed breast cancer Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children.
REFNo: HS2931ES

The primary objective of this study is to confirm the dose of B/F/TAF FDC in HIV-1 infected pediatric participants, to confirm the dose of B/F/TAF TOS in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
Kampala,
Uganda 2023-07-06 17:23:47 2026-07-06 5 Adolescents and children Gilead Sciences Medical and Health Sciences Clinical Trial Non-degree Award
Thomas McHale
ID: UNCST-2022-R008812
 Optimizing the Dose of Flucytosine for Cryptococcal Meningitis
REFNo: HS2940ES

Determine if 50 mg/kg/day of 5-FC has a similar mortality benefit compared to 100 mg/kg/day,Reduce the cost and supply burden of treating an individual with cryptococcal meningitis,Determine if 50 mg/kg/day of 5-FC is a safer dosage compared to 100 mg/kg/day of 5-FC,Determine if 50 mg/kg/day of 5-FC is has a similar rate of cryptococcal clearance from CSF compared to 100 mg/kg/day,Determine the optimal dose of 5-FC for for management of induction phase of therapy for cryptococcal meningitis,
 Kampala,
Mbarara,
USA 2023-07-05 11:41:24 2026-07-05 The target sample size is 50 participants The study will enroll adults with HIV who are over 18 years old and sick with cryptococcal meningitis. National Institute of Health, United States Medical and Health Sciences Clinical Trial Degree Award
Daniella Akellot
ID:
EVALUATION OF THE EFFECTIVENESS OF CLORPACTIN IN COMPARISON WITH OTHER WOUND DRESSING AGENTS USED AT SIGN SUPPORTED HOSPITALS IN UGANDA
REFNo: HS2769ES

To determine the effectiveness of Clorpactin in wound dressing at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor.,
 Kumi, Booma South
Gulu, ForGod
 Uganda 2023-07-03 13:32:54 2026-07-03 546 patients Patients admitted at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor with surgical wound sepsis, infected open fractures, diabetic wounds, chronic osteomyelitis. SIGN Fracture Care International Medical and Health Sciences Clinical Trial Non-degree Award
Ezekiel Mupere
ID: UNCST-2023-R008637
 Earlier prime-BOOST schedule to improve MEasles protection in high burden settings (BoostME)
REFNo: HS2883ES

Safety Objectives 1.To assess the safety and reactogenicity profile of the vaccine when given at different ages 2.To assess the number of measles infections throughout the study. Primary Objectives 1.To compare protective measles antibody concentrations at 2.5 years of age in infants receiving an early (6 months) compared to standard (9 month) dose of MCV, and a booster dose at 18 months of age. 2.To compare protective measles antibody concentrations one month after a second dose of MCV given at 12 months (early) compared to standard (18 months), in those who received an early (6 months) first dose. Secondary Objectives •To describe the measles antibody concentrations one month after first dose in infants receiving an early (6 months) compared to standard (9 month) dose of MCV. •To describe the effect of maternal antibodies on infant humoral and cellular immune response to first and second doses in children vaccinated under different schedules. •To describe the effect of maternal HIV infection on infant antibody responses post MCV1 and MCV2 given at different schedules •To describe the impact of different vaccination schedules on responses to the rubella component of the vaccine. Community Objectives To assess the effect of a measles vaccination clinical trial on public perceptions of measles immunisation
 Kampala, Kawaala
Kampala, Kisenyi
Kampala, Komamboga
Kampala, Mulago
 Uganda 2023-06-23 7:46:04 2026-06-23 450 infants Any infant aged 6 months (23-28 weeks) at screening visit and has not received prior vaccination against measles University of Oxford Research Governance, Ethics and Assurance Joint Research Office Boundary Brook House Churchill Drive Headington Oxford OX3 7GB United Kingdom, and funded by Bill and Melinda Gates Foundation. Medical and Health Sciences Clinical Trial Non-degree Award
Tonny Kiyimba
ID:
Efficacy of polyphenols from Tamarindus indica fruit juice on cardiometabolic health of patients living with HIV and elevated triglycerides: A study protocol
REFNo: HS2923ES

3. To establish dose response dynamics of long-term intake of T. indica fruit juice polyphenols on selected cardiometabolic risk markers of PLWH.,2. To assess the effect of an acute, single-dose intake of T. indica fruit juice on vascular function, lipid profile and plasma levels of procyanidin metabolites.,1. To produce and evaluate the sensory acceptability of T. indica fruit juice.,To determine the efficacy of T. indica fruit juice on selected cardiometabolic risk markers of PLWH in HIV community care model in Wakiso district, Uganda.,
 Wakiso, Kajjansi
Wakiso, Kajjansi
 Uganda 2023-06-20 11:05:36 2026-06-20 240 Participants will be adult(30-50 years) male and female patients living with HIV (PLWH) managed under the community-based model (Community Drug Distribution Points-CDDPs) in Wakiso district, central Uganda. The district encircles Kampala, Uganda's capital city with an estimated population of over 2.9 million people. The district has the highest prevalence (10%) of HIV in Uganda. Over 3,801 PLWH are currently receiving the HIV care from CDDPs in Wakiso District. The study inclusion and exclusion criteria are presented in Table 1. VLIROUS Medical and Health Sciences Clinical Trial Degree Award
Betty Mwesigwa
ID: UNCST-2020-R014667
 SABIN-002: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
REFNo: HS2838ES

To evaluate the safety and tolerability of
cAd3-Marburg vaccine
 Kampala, Nakasero
 Uganda 2023-06-14 11:06:46 2026-06-14 80 Male and female adults, 18-70 Years Sabin Vaccine Institute Medical and Health Sciences Clinical Trial Non-degree Award
NANKWASA SAILAS
ID:
RANDOMIZED CONTROLLED FOR NON USE OF ANTIBIOTIC AFTER UNCOMPLICATED VAGINAL BIRTH AND POST-PARTUM ENDOMETRITIS AT ST FRANCIS HOSPITAL NSAMBYA
REFNo: HS2768ES

3. To determine the factors that may predict the likelihood of infection after uncomplicated vaginal birth at St. Francis Nsambya Hospital,2. To determine the incidence of perineal tear/episiotomy wound breakdown among women who received antibiotic and those who do not at St. Francis Nsambya Hospital,1. To determine the incidence of post-partum endometritis after uncomplicated vaginal birth in women who receive antibiotic compared to those who do not at St. Francis Nsambya Hospital,To determine whether not providing an antibiotic after uncomplicated vaginal birth is associated with increased incidence of post-partum endometritis at St. Francis Nsambya Hospital,
 Kamuli, Nsambya
Uganda 2023-06-06 7:53:44 2026-06-06 260 participants adult post delivery mothers with uncomplicated vaginal birth NANKWASA SAILAS Medical and Health Sciences Clinical Trial Degree Award
RICHARD MPANGO STEPHEN
ID:
Adaptation and Evaluation of the New Forest Parenting Program (NFPP) in the management of ADHD among Children and Adolescents infected with HIV (CA-HIV) in Uganda (Formative phase)
REFNo: SS1721ES

i) To adapt and evaluate the effectiveness of the NFPP in the management of ADHD among Children and adolescents infected with HIV (CA-HIV).
ii) To evaluate the acceptability and feasibility of NFPP in the management of ADHD among CA-HIV.
 Masaka, NOT APPLICABLE
Kampala, NOT APPLICABLE
 Uganda 2023-05-29 20:36:58 2026-05-29 44 Twenty-two (22) participants; ten (10) Child and adolescent mental health specialists’ and HIV clinicians (representing a range of professional disciplines including psychiatrists, psychologists, psychiatric clinical officers, psychiatric nurses, experienced HIV counsellors and HIV clinicians); ten (10) parents / grandparents / teachers /day-mothers / guardians / caregivers; two (2) facilitators CHILD Global Research Social Science and Humanities Clinical Trial Degree Award
Richard Idro
ID: UNCST-2021-R013599
 Dihydroartemisinin-piperaquine and azithromycin for the post-discharge management of children with severe anaemia in Malawi, Kenya and Uganda; A, multicentre, parallel-group, two-arm, randomised, double-blind superiority trial.
REFNo: HS2815ES

To determine if PDMC with four courses of monthly AZ treatment in combination with four months of weekly DP is superior to PDMC with weekly DP-alone in reducing non-malaria SCCV by six months post-discharge in children aged <5 years admitted with severe anaemia (Hb<5g/dl) who are ready to be discharged and are clinically stable and able to switch to oral medication,
 Jinja, Jinja City
Kitgum, Municipality
 Uganda 2023-05-25 12:04:54 2026-05-25 958 Children aged less than 5 years, with severe anemia. Training and Research Unit of Excellence, Blantyre, Malawi Medical and Health Sciences Clinical Trial Non-degree Award
David Meya Bisagaya
ID: UNCST-2019-R000837
 Platform Trial For Cryptococcal Meningitis - PLATFORM-CM
REFNo: HS2649ES

The purpose of this study is to know whether this oral form of amphotericin (MAT2203) is safe and effective in the treatment of people sick with cryptococcal meningitis.
 Mbarara, Mbarara
Masaka, Masaka
Kampala, Kampala
 Uganda 2023-05-25 12:01:51 2026-05-25 270 Adult (18 years and above) males and females HIV-infected persons with cryptococcal meningitis. Matinas BioPharma Nanotechnologies, Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Dominik Biesalski
ID:
The Drivers, Effects and Measurement of Time Use Among the Urban Poor: Evidence from Uganda
REFNo: SS1674ES

Get insights into the time use patterns of urban workers and understand their effects on productivity and well-being.
 Kampala, Kampala
 Germany 2023-05-11 14:41:00 2026-05-11 200 Workers who are older than 18 years old, both men and women of all tribes Private Enterprise Development in Low-Income Countries (PEDL) Social Science and Humanities Clinical Trial Degree Award
James Davis KATUMBA
ID:
Uncontrolled asthma among adolescents in selected secondary schools in Kampala City: Prevalence, associated factors, in-school needs, pathways to care and effectiveness of an mHealth Self-management app
REFNo: HS2791ES

To determine the effectiveness, acceptability and feasibility of the KmAsthma self-management app in improving the control of asthma among day scholar secondary school adolescents 12-19 years old in Kampala City Uganda.,To examine pathways to asthma care and their influence on asthma control among secondary school adolescents with asthma in Kampala City Uganda ,To establish the in-school needs associated with asthma control among adolescents in selected secondary schools in Kampala City Uganda ,To determine the prevalence of and factors associated with uncontrolled asthma among adolescents in selected secondary schools in Kampala City Uganda ,To establish the prevalence of and factors associated with uncontrolled asthma, in-school needs, pathways to asthma care, and effectiveness of KmAsthma Self-management app intervention to control asthma among adolescents in selected secondary schools in Kampala City Uganda,
 Kampala, Kawempe, Rubaga, Makindye, Kampala Central, Nakawa
 Uganda 2023-05-02 22:22:49 2026-05-02 323 Secondary school adolescents in Kampala City Uganda who will provide written informed consent (or assent plus consent from parents in case of minors) during the time of the study. Self Sponsored Medical and Health Sciences Clinical Trial Degree Award
John Kellett Gale
ID:
Can continuous non-invasive monitoring of movement predict and detect clinical deterioration of hospital patients earlier and more efficiently than traditional intermittent observations?
REFNo: HS2765ES

To determine if continuously collected accelerometer data can indicate and identify clinical deterioration of acutely ill hospitalised patients before intermittently collected vital signs.
 Masaka, Ssenyange
 Ireland 2023-05-02 22:11:25 2026-05-02 1100 All non-pregnant patients aged 18 years or over admitted to the medical ward for any medical condition who are competent to provide consent to participate in the study or have a surrogate decision maker who can consent on their behalf. Patients may decide to participate or withdraw from the study at any time during their hospitalization. Dr John Kellett Medical and Health Sciences Clinical Trial Non-degree Award
Grace Ndeezi
ID: UNCST-2019-R001802
 Nutritional management of growth faltering in infants aged under six months. Study protocol for an individually randomised trial
REFNo: HS2766ES

To determine the effect of nutritional supplementation plus intensive breastfeeding support compared with intensive breastfeeding support alone on mortality, morbidity and growth in infants aged 0-6 months with growth faltering in low resource settings in South Asia and Sub-Saharan Africa.
Iganga,
Iganga,
Iganga,
Iganga,
Iganga,
Mayuge,
Mayuge,
Uganda 2023-04-26 11:15:23 2026-04-26 900 infants Pregnant women (and adolescents) aged 15 to 45 years. Their babies will be enrolled at birth for a nutritional intervention. Both female and male babies will be enrolled. There will be no exclusion based on tribe as long as they comprehend English and Lusoga. World Health Organisation Medical and Health Sciences Clinical Trial Non-degree Award
ELIZABETH ASIGE
ID:
THE IMPACT AND COST-EFFECTIVENESS OF A COMMUNITY-BASED PROGRAM FOR CHILDREN WITH CEREBRAL PALSY AND THEIR CAREGIVERS AND THE STAKEHOLDERS IN UGANDA.
REFNo: HS1979ES

1. To examine the impact of a community-based program on children with CP reported frequency of participation in the home, school, and community activities. 2. To assess the impact of a community-based training program on improving caregiver knowledge regarding CP and reducing caregiver stress. 3. To determine the impact of a communication and advocacy program in broadening stakeholders’ knowledge, attitude and practices regarding childhood disability and inclusion. 4. To determine the cost-effectiveness of a community-based program on children with CP, their caregivers, and the stakeholders in relation to costs and benefits.
Iganga, Iganga
Mayuge, Mayuge
 Uganda 2023-04-20 21:15:22 2026-04-20 100 participants- 50 in the study group and 50 in the control group The study population will comprise children and youth with cerebral palsy aged 2-22 years, both male and female, and their primary caregivers of any tribe living in the study communities plus the community stakeholders Prof. Hans Forssberg -Karolinska Institutet Astrid Lindgren Children’s Hospital 17176, Stockholm Sweden Medical and Health Sciences Clinical Trial Degree Award
Beatrice  Onyango Ekesa
ID:
Bio-efficacy of Pro-Vitamin A-rich banana to improve vitamin A status among children in Uganda living in an area with a high burden of inflammation
REFNo: HS2721ES

3. Establish the stability of retinol isotopes on DSS at room temperature in the determination of TBS of vitamin A.,2. Assess the effect of inflammation and nutritional status on vitamin A absorption and TBS assessment among school-aged Ugandan children.,1. Determine the bio-efficacy of carotenoids in Pro-Vitamin A rich bananas in improving TBS in children aged 6-14years.,This study will determine the bio-efficacy of carotenoids in Pro-Vitamin A-rich banana-based diets and their potential in improving the vitamin A body stores by the RID technique among school-going children aged 6-14years living in Tororo district, an area with a high burden of inflammation.,
 Tororo, Aturukuk
 Kenya 2023-04-19 12:44:24 2026-04-19 110 The study will be conducted among school going children aged 6-14 years because the school setting facilitates the feeding trial and monitoring, and the age group forms the youngest group available in an organised setting that can easily be engaged for a long period. In addition, this age group is not involved in the current national vitamin A supplementation programs. International Atomic Energy Agency (IAEA) Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Evaluation of National HIV Testing Services Algorithm
REFNo: HS2701ES

Main Objective
To determine the appropriate HIV rapid test algorithm to be used in Uganda considering the new kits on the market.

Specific objectives
1. To assess specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV) of the rapid HIV tests on the market in Uganda and come up with best RDT algorithm.
2. To identify an algorithm that will best identify acute HIV infections
3. To determine the inter-observer and inter-lab agreement in HIV diagnosis using evaluated RDTs.

 Gulu, Lacor hospital
Mbarara, Mbarara hospital
Tororo, AIC and TASO
Central Region, UVRI CLINIC
 Uganda 2023-04-12 15:44:58 2026-04-12 3500 Adults aged 18 years and above who would have come for an HIV test The Global Fund Medical and Health Sciences Clinical Trial Non-degree Award
Francis Ssali
ID: UNCST-2021-R012134
 Protocol A5394: “Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV” Version 1.0, May 27, 2022
REFNo: HS2647ES

1.2 Primary Objectives

1.2.1 To assess the safety and tolerability of treatment with SLGN administered once weekly by mouth for 24 weeks.

1.2.2 To determine the proportion of participants with ≥1 log10 IU/mL decline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24.

1.3 Secondary Objectives

1.3.1 To determine the proportion of participants with ≥1 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.2 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg after SLGN treatment at Week 24.

1.3.3 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.4 To evaluate the proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up.

1.3.5 To evaluate changes in qHBsAg levels at Weeks 4, 12, 24, 36, and 48 after SLGN initiation and, separately, among the placebo recipients.

1.3.6 To determine the proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study, by study arm.

1.3.7 To determine the proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study, by study arm.

1.3.8 To determine the proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study, by study arm.
1.3.9 To evaluate levels of circulating cytokines, including IFN-gamma, IL-12p40, IL-1RA, and CD163 at entry, 24 hours post-first study drug dose, Weeks 4, 12, 24, 36, and 48, by study arm.

1.3.10 To determine whether administration of SLGN will perturb HIV latency as measured by an increase in HIV transcription.

1.3.11 To determine whether administration of SLGN will decrease the size of the latent reservoir, as measured by the change in amount of cell-associated unspliced HIV RNA, HIV DNA, replication-competent and/or intact virus at Weeks 2, 4, 24, and 48.

1.4 Exploratory Objectives

1.4.1 To define the pharmacokinetic (PK) profile and PK-pharmacodynamic (PD) associations of SLGN in people with both HIV and CHB taking suppressive antiviral therapy for both viruses.

1.4.2 To explore if SLGN and antiretroviral (ARV) PK are altered when administered together.

1.4.3 To evaluate participants’ adherence by using several tools, including self-report, directly observed therapy (DOT), and drug concentrations.

1.4.4 To compare quantitative changes in experimental measures of HBV antiviral efficacy (including HBV RNA, hepatitis B core related antigen [HBcrAg], qHBeAg, and low positive HBsAg measured with a high sensitivity qHBsAg assay [LLOQ of 0.05 IU/mL]) and measure changes in large, medium, and small HBsAg isoforms from baseline during and after treatment.

1.4.5 To determine the immunological effects of SLGN on circulating immune signaling by performing single cell RNA sequencing using peripheral blood mononuclear cells (PBMCs) and evaluating HIV-specific T-cell responses.

1.4.6 To determine the effects on circulating immune cells, including cellular phenotypes and T and B-cell responses.

1.4.7 To determine whether administration of SLGN will affect levels of circulating cytokines, including TNF-alpha, IL-12, IL18, IP-10, ISG15, IL-21, Fas Ligand, and TRAIL.

 Kampala, Seguku
 Uganda 2023-04-12 14:38:49 2026-04-12 The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if replacements are needed for key analyses. Participants with both (1) HIV and chronic hepatitis B (CHB) on suppressive effective antiviral therapy for HIV (ART) and HBV for ≥5 years immediately prior to study entry and (2) screening quantitative hepatitis B surface antigen (qHBsAg) >1000 IU/mL, and without evidence of advanced liver fibrosis or cirrhosis. Enrollment of women (female sex assigned at birth) is encouraged, and the study will set an enrollment goal of at least 14 women. The study is expected to enroll participants in North America, South America, Africa, and Asia. For the first 9 months, enrollment will be capped at 24 participants at US sites and 24 participants at non-US sites. After 9 months, enrollment will be open to all sites without regional caps The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if r eplacements are needed for key analyses. There are no Uganda specific differences. National Institute of Allergy and Infectious Diseases, Gilead Sciences, Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 A multiple arm, multiple stage (MAMS), phase 2B/C, open label, randomized, controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin and sutezolid, in adult subjects with newly diagnosed, smear-positive pulmonary tuberculosis
REFNo: HS2644ES

Primary Efficacy Objective:
Rifampicin- containing experimental arms (arms 1,2)
To evaluate whether one or more of two experimental regimens based on
optimized dose rifampicin, optimized dose of pyrazinamide, and moxifloxacin
given for 12, respectively 17 weeks, are superior to standard treatment given for
26 weeks, as assessed by time to sputum culture conversion to negative in liquid
media.
Sutezolid-containing experimental arm (arm 4)
 To evaluate whether the efficacy of an experimental regimen composed of
sutezolid, delamanid, bedaquiline, and moxifloxacin given for 17 weeks is
superior to standard treatment given for 26 weeks, as assessed by time to
sputum culture conversion to negative in liquid media.
Secondary Objectives This study’s secondary objectives are:
Efficacy
 To assess treatment efficacy based on proportion of patients with relapse
free outcome at 12 months after randomization.
 To assess treatment efficacy based on the rate of decline of bacterial load
measured by the Molecular Bacterial Load Assay
 To rank the relative efficacy of the experimental four-drug combinations
for the treatment of pulmonary tuberculosis within the first twelve weeks
of treatment, and select the most efficient experimental treatment
regimen or regimens for further development.
Safety and Tolerability
To assess the frequency, severity, and type of adverse events (AEs), and AErelated
treatment discontinuations.
Pharmacokinetics
To describe the pharmacokinetics of the drugs and doses used, and to assess
possible relationships between pharmacokinetic parameters of the various drugs and between pharmacokinetic parameters and participant characteristics.
Pharmacodynamics To describe relationships between pharmacokinetic parameters on the one hand and efficacy and safety endpoints on the other hand.
 Kampala, Kawempe
 Uganda 2023-04-11 15:27:11 2026-04-11 360 Adults A total of up to 360 adult (≥ 18 years of age) participants will be enrolled. In case of a high number of dropouts or non‐evaluable participants, it may be necessary to recruit more participants into the study. Also, if the stage 2 starts later than stage 1, it will be necessary to increase the number of control arm participants to achieve a 1:1 ratio of concomitantly recruited control and arm 4 participants (see sample size considerations). Both males and females regardless of tribe as long as an ICF of that particular language spoken by the participant is available, will be enrolled. LMU Klinikum Marchioninistr. 15, 81377 Munich Germany Medical and Health Sciences Clinical Trial Non-degree Award
Brenda Kakayi Catherine
ID: UNCST-2022-R008787
 Insulin-like Growth Factor/Growth Hormone Levels and Stunting in HIV Exposed Uninfected Children from the 1077BF/P1084s study (CHASE: Changes in IGF/Hormone Axis and Stunting in HIV-Exposed uninfected children.
REFNo: HS2686ES

1. To investigate IGF-1, IGFBP-1, and IGFBP-3 as predictors of growth faltering/stunting in the first 2 years of life in HEU children

2. To describe the concentrations of hormonal growth factors in infants in relation to infant growth percentile at birth, 26 weeks, and 74 weeks of age.

Uganda 2023-04-03 20:41:44 2026-04-03 Samples from approximately 154 participants from the P1084s study Samples of approximately 154 P1084s HEU children with serum specimens available at birth, week 26, and week 74 will have assays done on stored specimens for IGF-1, IGFBP-1, and IGFBP-3 at these time points. The 154 participants will be randomly selected from the 268 participants from Uganda, Malawi and South Africa that were enrolled in the study. The samples for use will be from both male and female participants. DAIDS-IMPAACT Network Medical and Health Sciences Clinical Trial Non-degree Award
JOSELYN RWEBEMBERA
ID: UNCST-2021-R013915
 Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A non-inferiority randomized trial. (GOALIE)
REFNo: HS2659ES

Primary Objective:
To compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.

 Lira, Adyel
 Uganda 2023-03-24 2:23:26 2026-03-24 1004 Age group = 5-17 Sex not specified. Tribe not specified. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Victoria Ndyanabangi
ID: UNCST-2021-R012645
 IMPAACT 2036: Phase I/II Study of the Safety, Tolerability,Acceptability, and Pharmacokinetics of Oral and Long-ActingInjectable Cabotegravir and Rilpivirine in Virologically SuppressedChildren Living with HIV-1, Two to Less Than 12 Years of Age, DAIDSStudy ID #38932 IND # 138754
REFNo: HS2688ES

To propose the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV)followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA)in children living with HIV-1, and to describe participant choice and experience with theregimen with or without an oral lead-in period.
To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable)through Week 24
To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oraland injectable) through Week 24
To assess the safety of CAB + RPV (oral and injectable) through Weeks 48 and 72
To describe the repeat-dose pharmacokinetics of injectable CAB LA + RPV LA throughWeeks 48 and 72
To assess the maintenance of viral suppression of CAB + RPV (oral and injectable)through Weeks 24, 48, and 72
To evaluate the tolerability and acceptability of injectable CAB LA + RPV LA throughWeeks 24, 48, and 72
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during study treatment
To assess immunologic activity of CAB + RPV (oral and injectable) through Weeks 24,48, and 72
To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable)and 44 weeks of CAB LA + RPV LA (injectable only)
To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV(oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe the maintenance of viral suppression and immunologic activity of 48 weeks ofCAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CABLA + RPV LA (injectable only)
To characterize long-term safety and washout PK through 48 weeks after permanentdiscontinuation of injectable CAB LA + RPV LAV LA
To characterize PK of CAB + RPV oral formulations when dispersed in liquid vs. directly ingested (Weight Bands 3, 4 and 5)
 Kampala, Mulago
 Uganda 2023-03-16 12:55:20 2026-03-16 35 Children living with HIV-1, two years to less than 12 years of age and weighing ≥10 kg and <40 kg, who are Virologically suppressed on stable antiretroviral therapy and their parents/caregivers. Proposed the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV) followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA) in children living with HIV-1, and to describe participant choice and experience with the regimen with or without an oral lead-in period. National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
 GS-US-380-1474: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
REFNo: HS2708ES

This is a multisite, multi-cohort study that aims to recruit subjects in four weight-based cohorts (i.e. Cohort 1, 2, 3 and 4), with each cohort having specific objectives aligned with it. Baylor Uganda site will recruit subjects in cohort 4 with is further subdivided in 4 weight-based sub-groups. The study objectives in relation to the Cohort 4 are as follows;
Cohort 4
Group 1:
The primary objective of this study is:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets

• To evaluate the antiviral activity of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Weeks 24 and 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
Group 2:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the antiviral activity of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg.
Group 3:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the antiviral activity of B/F/TAF 3.75/15/1.88 mg (administration of 1 × B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
Group 4:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg.

• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

• To evaluate the antiviral activity of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

 Kampala, Mulago
 Uganda 2023-03-16 12:47:17 2026-03-16 10 4.1 Selection of the Study Population Approximately 170 pediatric subjects ≥ 1 month to < 18 years of age are planned to be enrolled into the entire study. However, 50 child subjects shall be recruited as follows for Cohort 4 across all participating sites; at least 8 evaluable subjects ≥ 2 years of age weighing ≥ 14 to < 25 kg and at least 42 evaluable subjects ≥ 1 month of age weighing ≥ 3 to < 14 kg are planned to be enrolled. Baylor Uganda site however, plans to recruit a total of 10 children in cohort 4 (i.e. 3 children in each of the groups 1, 2 and 3 and 1 child in group 1). In addition, replacement subjects may be enrolled for subjects whose Intensive PK data are not evaluable or who do not complete all Intensive PK procedures in Groups 2, 3, and 4 of Cohort 4. 4.2 Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. a) Age ≥ 1 month to < 18 years (according to requirements of enrolling Cohort) b) Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements. c) Body weight at screening for Cohort 4: • Group 1: ≥ 14 to < 25 kg (≥ 31 to < 55 lbs) • Group 2: ≥ 10 to < 14 kg (≥ 22 to < 31 lbs) • Group 3: ≥ 6 to < 10 kg (≥ 13 to < 22 lbs) • Group 4: ≥ 3 to < 6 kg (≥ 6.6 to < 13 lbs) d) Confirmed HIV infection if < 18 months of age (positive nucleic acid-based test result to be provided). e) Adequate renal function: • Estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73 m2 (≥ 1.5 mL/sec/1.73 m2) for children ≥ 1 year of age using the Schwartz Formula. • Adequate renal function: eGFR ≥ the minimum normal values for age for children < 1 year of age using the Schwartz Formula. o Schwartz formula (mL/min/1.73 m2) = k × L/SCr where k is a proportionality constant, L is height in centimetres (cm) and SCr is serum creatinine (mg/dL). The value of k is 0.45 for children < 1 year old, 0.55 for children ≥ 1 to < 12 years old and adolescent girls ≥ 12 years old and 0.70 for adolescent boys (≥ 12 years old). f) Stable ARV regimen: • Stable ARV regimen of 2 NRTIs in combination with a third agent for a minimum of 6 months prior to the screening visit. Subjects undergoing dose modifications to their ARV regimen for growth or who are switching medication formulation(s) are considered to be on a stable ARV regimen (Cohort 4 Group 1). • Stable ARV treatment of 2 NRTIs in combination with a third agent for a minimum of 1 month prior to the screening visit or treatment naive (Cohort 4 Groups 2, 3, and 4 only) (patient is considered treatment naive if ARVs were given for prevention of mother-to-child transmission only and not for HIV treatment) g) Plasma HIV-1 RNA: < 50 copies/mL at the screening visit (Cohort 4 Group 1). No threshold for HIV RNA levels for Cohort 4 Groups 2, 3, and 4. h) Life expectancy ≥ 1 year. i) Have no documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. Subjects with M184V/I AND HIV-1 RNA < 50 copies/mL may be enrolled in Cohort 4. Subjects in Cohort 4 with HIV-1 RNA > 50 copies/mL shall have documentation of no FTC, TFV, or INSTI resistance by plasma testing at screening (> 200 copies/mL) or historical genotype (if > 50 copies/mL but < 200 copies/mL). j) Care taker(s) must be willing and able to comply with all study requirements. 4.3 Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. a) Cohort 4 Group 1: CD4 cell count < 200 cells/ mm3. Cohort 4 Groups 2, 3, and 4: CD4 cell count < 750 cells/mm3 for ≥1 to <12 months of age and < 500 cells/mm3 for ≥12 to <24 months of age. b) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening. c) An ongoing serious infection requiring systemic antibiotic therapy at the time of screening d) Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months e) Acute hepatitis in the 30 days prior to study entry f) Hepatitis B virus (HBV) surface antigen (HBsAg) positive g) Hepatitis C virus (HCV) antibody positive with detectable HCV RNA. Children < 18 months of age born to an HCV positive mother and/or HCV antibody positive will need to have 2 negative HCV RNA tests 6 months apart with the first test occurring no earlier than 2 months of age. In this situation, the earliest such a patient can be screened for study eligibility is at 8 months of age. h) Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, haematological, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to Day 1. i) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy) j) A history of or ongoing malignancy other than cutaneous Kaposi’s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study. k) ≤ 2 months of age and gestational age (GA) ≤ 37 weeks (Cohort 4 Groups 2, 3, and 4) l) Current alcohol or substance abuse (by parent/caretaker) judged by the Investigator to potentially interfere with subject compliance m) Have history of significant drug sensitivity or drug allergy n) Known hypersensitivity to the IMP, the metabolites, or formulation excipients. o) Participation in any other clinical trial, including observational studies without prior approval from sponsor is prohibited while participating in this trial. p) Cohort 4 Groups 2, 3, and 4: Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrolment q) Subjects receiving ongoing therapy with any medication that is not to be taken with the study drug. Administration of any of the following medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study, with the exception of the subject’s prior ARV treatment regimen, which must be continued until their scheduled Day 1 visit Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 Medical and Health Sciences Clinical Trial Non-degree Award
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