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).
Search By Approval Date:
Clear Filter Total: 317
Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
Francis Kiweewa
ID: UNCST-2020-R014929
 A Global Multi-Center, Randomized, Blinded, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older
REFNo: HS2476ES

The objective of this study is to evaluate the effectiveness, safety, and the ability of the study vaccine to provoke an immune response in your body against COVID-19. This study is necessary because the COVID-19 epidemic poses a significant global health challenge, and a large number of effective vaccines are still needed for the future. A total of approximately 34,000 participants like you from around the world, such as Africa and Asia will participate in this study. The entire study will last approximately 20 months, and your participation will last approximately at least 17 months. (The exact duration of your participation in the study may depend on the specific situation of the study. Please consult your study doctor at that time.)
 Wakiso,
Kampala,
Lira,
Tororo,
Uganda 2022-09-28 14:10:52 2025-09-28 234 Adults aged 18 years and older of all sexes. AIM Vaccine Co., Ltd, AIM Innovation Biotechnology (Shanghai) Co., Ltd, LiveRNA Therapeutics Inc. & Ningbo Rongan Biological Pharmaceutical Co., Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 Efficacy, Safety and Effectiveness of Injectable Cabotegravir/Rilpivirine in Improving HIV Control in Sub-Saharan Africa: A pragmatic Phase 3 Open-label Randomized Controlled Trial.
REFNo: HS2475ES

Primary objective:
To demonstrate the non-inferior efficacy of switching to every 2 months (Q2M) intramuscular (IM) injection of cabotegravir (CAB) long acting (LA) plus rilpivirine (RPV) LA compared with continuation of first-line oral ART over 12 months in people living with HIV (PLHIV) with a history of, or at risk of, sub-optimal HIV control.

Secondary objectives:
1) To demonstrate the antiviral activity and the impact on retention in HIV care of switching to Q2M CAB LA + RPV LA compared with continuation of oral ART over 12 and 24 months in PLHIV with a history of, or at risk of, sub-optimal ART adherence or engagement in care.

2) To demonstrate the immunological activity of switching to Q2M CAB LA + RPV LA compared with continuation of oral ART over 12 and 24 months in PLHIV with a history of, or at risk of, sub-optimal ART adherence or engagement in care. This will be measured through change in CD4+ T cell count and incidence of HIV disease progression.

3) To evaluate the safety and tolerability of switching to Q2M CAB LA + RPV LA compared to continuation of oral ART.

4) To assess genotypic viral resistance in participants experiencing protocol-defined confirmed virological failure (plasma HIV-1 RNA >200 c/ml) and its impact on future treatment options including proportion who resuppress on dolutegravir.

5) To evaluate the effect of Q2M CAB LA + RPV LA on health-related quality of live, treatment satisfaction and treatment adherence. To describe cost-effectiveness and acceptability of the regimen.

Kampala, NOT APPLICABLE
Wakiso, Entebbe
Western Region, Fort Portal
 Uganda 2022-11-02 17:27:11 2025-11-02 540 Age: Adults 18 years and above Gender: Any Source: HIV clinics in Uganda (MRC/UVRI & LSHTM Entebbe, Infectious Diseases Institute Kampala, Joint Clinical Research Centre clinics in Fort Portal and Lubowa) Method of recruitment: Pre-screening of clinic database to identify potentially eligible participants who are counselled about the study and invited to be screened. Only adults who are eligible after the screening period are randomized. London School of Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Namulema Edith
ID:
Feasibility of using Continuous Positive Airway Pressure via the ‘LeVe CPAP System’ among Children with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A mixed methods study
REFNo: HS2478ES

1) To assess the acceptability of the LeVe CPAP system to deliver continuous positive airway pressure among children with acute hypoxemic respiratory failure at Mengo Hospital Uganda.
2) To assess the safety of LeVe CPAP system among children with acute hypoxemic respiratory failure at Mengo Hospital Uganda.

Kampala, 1
 Uganda 2022-11-09 13:49:10 2025-11-09 40 Paediatric patients of Age > 1 month with hypoxemic respiratory failure and caretakers admitted at the paediatric ward. Leeds University Medical and Health Sciences Clinical Trial Non-degree Award
Bonny Aloka
ID: UNCST-2022-R010624
 Development and Evaluation of Nutrient-Dense Composite from Local Food Materials to Manage Moderate Acute Malnutrition (MAM) and Nodding Syndrome in northern Uganda
REFNo: A234ES

3. To investigate the stakeholder perception regarding the nutrient dense composites developed to manage MAM and NS in Acholi and Lango sub-regions,To evaluate the efficacy of the recipes in improving the conditions of clients with MAM and nodding syndrome in Acholi and Lango sub-regions,To test the level of acceptability of the developed composites by the selected mothers/care takers and their children in Acholi and Lango sub-regions,To develop a nutrient dense composites from local food materials to manage MAM and nodding syndrome in Lango and Acholi sub-regions,To develop a nutrient dense composite from local food materials to manage moderate acute malnutrition (MAM) and nodding syndrome in Lango and Acholi sub-regions in northern Uganda.,
 Lira, Ayami Parish
Alebtong, Ayami Parish
Kole, Akwirididi Parish
Oyam, Atura Parish
Gulu, Pawel Parish
Nwoya, Kalatocon Parish
Pader, Kalawinya Parish
Kitgum, Pajimu Parish
 Uganda 2022-11-28 11:12:34 2025-11-28 387 The study population will be children between 6-23 months (MAM), Children aged 3-28 years (nodding syndrome) and adults aged 18-80 years of age (sensory evaluation). European Union Agricultural Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-MTM in African children living with HIV.
REFNo: HS2496ES

Primary objective a) To assess the safety and reactogenicity profile of the malaria vaccine candidate R21/Matrix-MTM in 5-36-month-old African children living with HIV Secondary objectives a) To assess the humoral immunogenicity of R21/Matrix- MTM in 5-36-month-old African children, comparing children living with HIV with HIV negative children b) To assess the impact of vaccination on HIV reservoir c) To assess whether increasing age and nadir CD4 count are associated with immunogenicity of R21/Matrix-MTM in 5-36- month-old African children living with HIV Tertiary objectives a) To assess the immunogenicity profile of R21/Matrix-MTM in 5- 36-month-old African children, comparing children living with HIV with HIV negative children
 Wakiso, Central
 Uganda 2022-10-20 18:13:49 2025-10-20 120 120 Children aged 5-36 months will be recruited to the trial. HIV positive children will be recruited from Pediatric HIV care centers within Kampala and Wakiso districts while HIV negative children will be recruited from Entebbe hospital and primary health care centers that provide immunisation and growth monitoring services within Kampala and Wakiso districts. 100 children with confirmed HIV infection will be recruited to group 1 and 20 children without HIV will be recruited to group 2. The Serum Institute of India Pvt Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
 Long-Acting Treatment in Adolescents (LATA); A randomized open-label 2-arm 96-week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa version 1.0 dated 01 December 2021.
REFNo: HS2515ES

• To evaluate an innovative and contemporary ART strategy in HIV- positive adolescents to provide choice for young people facing life-long treatment.
• To evaluate the virological efficacy, safety, acceptability, and quality-of-life of the dual long-acting injectable combination, cabotegravir and rilpivirine, antiretroviral therapy compared to continuous daily oral therapy with triple oral ART consisting of DTG with a backbone of tenofovir either as the TAF or TDF formulations, combined with either 3TC or FTC regimen, to optimize treatment for HIV-positive adolescents in sub-Saharan Africa.

 Kampala, Mulago
 Uganda 2026-01-27 19:28:37 2029-01-27 170 Adolescents aged 12 to 19 years of age living with HIV-1 who are not pregnant or breastfeeding, and are virologically-suppressed (HIV-1 RNA <50 copies/mL) for at least one year, without any known history of treatment failure, on a 3-drug combination ART consisting of an anchor drug with a 2-drug nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone. There will be no exceptions to eligibility requirements at the time of randomisation. Questions about eligibility criteria should be addressed prior to attempting to randomise the participant. The eligibility criteria are the standards used to ensure that only medically appropriate patients are considered for this study. Patients not meeting the criteria should not join the study. For the safety of the patients, as well as to ensure that the results of this study can be useful for making treatment decisions regarding other patients with similar diseases, it is important that no exceptions be made to these criteria for admission to the trial. Participants will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria as defined below. INCLUSION CRITERIA 1. HIV-1-positive 2. Aged 12-19 years 3. Aware of HIV status 4. Body weight ≥35Kg 5. On ART consisting of 2NRTI and a third agent 6. On ART for ≥1 year with no previous regimen change for treatment failure* 7. Virologically suppressed with all HIV-1 RNA viral loads <50copies/mL¥ in the last 12 months up to and including screening. Additionally, there must be one result <50copies/mL¥ at least 12 months prior to screening and the viral load at trial screening must be <50 copies/mL 8. Written informed consent provided by participant (if aged 18 to 19 years) and/or carer/legal guardian (if participant aged 12 to 17 years) as appropriate 9. Written informed assent in participants aged 12 to 17 years 10. Females who are sexually active must be willing to adhere to highly effective methods of contraception⌂ EXCLUSION CRITERIA 1. Known HIV-2 positive 2. Females who are pregnant or breastfeeding 3. Females who plan to become pregnant during the trial follow-up or are sexually active and are unwilling to avoid pregnancy for the duration of the trial 4. Moderate or high-risk score on the Columbia-Suicide Severity Rating Scale 5. Hepatitis B SAg positive 6. ALT ≥3 x upper limit of normal 7. On treatment for active TB 8. Known contraindication to receipt of dolutegravir, cabotegravir, rilpivirine, emtricitabine/ lamivudine and any formulation of tenofovir 9. Participants determined by the investigator to have a high risk of seizure, including those with unstable or poorly controlled seizure disorder 10. Unwilling or contraindication to receiving injections 11. Contraindication to receiving injectable agents in the buttock area 12. Underlying medical condition (e.g. bleeding disorder; use of warfarin) that in the opinion of the investigator precludes participation 13. Previous randomisation in the BREATHER Plus trial University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership Medical and Health Sciences Clinical Trial Non-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
Bruce Kirenga J
ID: UNCST-2019-R001460
 SAFETY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF HERBAL PRODUCTS FOR THE TREATMENT OF ACUTE RESPIRATORY VIRAL INFECTIONS INCLUDING SARS-COV2 IN UGANDA; PHASE 2A OPEN LABEL CLINICAL TRIAL
REFNo: HS2548ES

The general objective is to assess the safety, pharmacokinetics and preliminary efficacy of TazCoV and Vidicine for the treatment of acute respiratory viral infections (SARS-CoV2, RSV and Influenza A/B) in Uganda.
Specific objectives
1. To determine the safety and pharmacokinetics of TAZCOV and Vidicine herbal products among adult patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza A/B

2. To determine the extent of SARS-CoV2, RSV and Influenza A/B viral clearance among adult patients with acute viral respiratory infection treated using TAZCOV and Vidicine

3. To establish time-to-remission of symptoms among patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine

4. To evaluate disease progression among patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine
 Kampala, Mulago
 Uganda 2022-11-29 12:38:24 2025-11-29 510 The maximum individual participant trial duration will be 90. The actual time the trial will last will depend on the rate of enrollment. It is estimated that the trial will take 18 months. days. The Government of Uganda through the Ministry of Science, Technology and Innovation-Office of the President (STI-OP) 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
Haruna Muwonge
ID: UNCST-2019-R000128
 EFFICACY AND SAFETY OF DIHYDROARTEMISININ-PIPERAQUINE (EURARTESIM) FOR TREATMENT OF UNCOMPLICATED P. FALCIPARUM MALARIA IN ADULT PATIENTS WITH COVID-19 CO-INFECTION: AN OPEN LABEL RANDOMISED PILOT CLINICAL TRIAL (EMCOS CLINICAL TRIAL)
REFNo: HS2563ES

To evaluate the incidence of adverse events in adult participants with uncomplicated P. falciparum malaria and COVID-19 coinfection receiving DHA/PPQ treatment or Artemether – lumefantrine treatment. ,To determine the efficacy of DHA-PPQ in treatment of adult patients suffering from uncomplicated P. falciparum malaria with COVID-19 coinfection.,To assess the therapeutic efficacy and safety of DHA-PPQ for the treatment of uncomplicated P. falciparum malaria- COVID-19 co-infection.
 Kampala, all parishes
Wakiso, all parishes
 Uganda 2022-11-17 18:12:26 2025-11-17 80 Adults of 18 years and above diagnosed with COVID-19 RT-PCR of SARS-CoV-2 plus a positive P. falciparum malaria parasite blood slide at Mulago National Referral Hospital, Kiruddu Hospital, and Entebbe regional referral Hospital. The study will include participants who are 18 years or more living around the areas of Kampala City, Wakiso District and Mukono District and who consent in writing to participate in the study. Alfasigma S.p.A. (Makerere University Lung Institute is CRO) Medical and Health Sciences Clinical Trial Non-degree Award
KENNETH MUGABE
ID: UNCST-2022-R010732
 Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study: LACTate in mATernal sEpsis
REFNo: HS2589ES

VI. Conduct a validation study of an alternative reference standard in which the SOFA score is modified to incorporate maternity specific ranges for creatinine and platelet concentration.,V. Exploratory analysis will examine the effect of adjusting the threshold values for both vital sign and lactate assessment on the sensitivity and specificity of the index tests.,IV. To explore if the test accuracy of lactate in addition to maternal vital sign monitoring alone varies by the pre-specified subgroups of pregnancy status (pregnant or post-delivery (including abortion or miscarriage)) and recruitment country.,III. To explore if baseline venous lactate, in addition to vital sign measurements, improves prediction of severe morbidity and mortality from infection.,II. To assess short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline.,I. Immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard.,Determine the diagnostic accuracy of maternal venous lactate measurement in addition to maternal vital sign thresholds, in maternal sepsis in low-resource health facility settings in Malawi, Uganda and Pakistan.,
 Uganda 2022-12-12 15:55:39 2025-12-12 500 (150 in Uganda) Women, 16years or greater, with suspected infections, who are pregnant or recently pregnant(up to 42 days) University of Liverpool Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 Ring vaccination trial to evaluate the efficacy and safety of Sudan ebolavirus vaccines in Uganda
REFNo: HS2574ES

Probable SUVD and death from confirmed SUVD ,main secondary objective is to assess the safety of the vaccine by monitoring weekly for 21 days any adverse reactions to vaccination and any other serious adverse events,The primary analysis will be of laboratory-confirmed SUVD (from samples taken either while living, or within 48 hours of death),
 Uganda 2022-11-23 15:04:05 2025-11-23 N/A All active contacts of Ebola viral disease, Participants aged 6 years and above, all tribes, all genders World Health Organisation and the Ministry of Health Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 Evaluation of the performance of novel molecular point of care diagnostics for SARS-CoV-2
REFNo: HS2588ES

To assess the ease of use of the molecular POC devices being evaluated using a System Usability Scale (SUS) questionnaire administered to platform’s operators (minimum 3, where possible)., To evaluate the diagnostic accuracy of such platforms in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RTPCR in specific subgroups defined based on disease stage (days since symptoms onset), RTPCR Ct values (as surrogate for viral load). Participant’s vaccination status, previous COVID-19 infection(s) and SARS-CoV-2 genetic variant causing participant’s infection, determined by sequencing of the viral genome, may also be considered as subgroups. , To evaluate the diagnostic accuracy of molecular POC devices in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RT-PCR (WHO EUL or FDA EUA approved), among COVID-19 symptomatic individuals,
 Kampala, Mulago
Kampala, Kiruddu
Kampala, Kawempe
Kampala, Butabika
 Uganda 2023-01-18 18:21:06 2026-01-18 200 The study will focus on adults with symptoms compatible with COVID-19 (and/or specimens collected from them) attending healthcare facilities in Uganda. If a participant is screened and enrolled but is not able to provide the specimens required for the study, this participant will be withdrawn. FIND GENEVA Medical and Health Sciences Clinical Trial Non-degree Award
Winnie  Muyindike R
ID: UNCST-2021-R013558
 A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on TLD in Sub-Saharan Africa.(RESOLVE)
REFNo: HS2620ES

Aim 2: Use simulation modeling to examine the clinical impact, costs, and cost-effectiveness of strategies to improve viral suppression after virologic failure on TLD. We will populate the previously validated Cost-Effectiveness of Preventing AIDS Complications-International (CEPAC-I) model with the novel clinical trial data from Aim 1 to project long-term clinical outcomes and cumulative lifetime costs. We will then compare the cost-effectiveness of the three strategies evaluated in Aim 1 for addressing virologic failure among people treated with first-line TLD in Uganda or South Africa. ,Aim 1: Conduct a randomized clinical trial to determine the optimal strategy for management of virologic failure on first-line TLD in SSA. We will recruit 648 adolescents and adults with two viral loads >1,000 copies/mL while on first-line TLD for at least 12 months, who are in care at one of six public-sector HIV clinics in Uganda or South Africa. We will randomize participants to one of the following strategies, stratified by clinic and prior NNRTI-exposure: a) Maintenance on TLD with switch to protease inhibitor (PI)-based second-line ART if virologic failure persists past six months; b) Individualized Care, with regimen choice based on results of genotypic resistance tests and urine tenofovir assays; or c) Immediate Switch to PI-based second-line ART. The primary outcome will be viral suppression (<50 copies/mL) at 48 weeks post-enrollment using the FDA snapshot definition. We hypothesize that rates of viral suppression at 48 weeks will be higher in the Individualized Care arm than in the Maintenance on TLD and Immediate Switch arms.,
 Mbarara, Kamukuzi
Mbarara, Kakoba
 Uganda 2023-02-09 11:06:56 2026-02-09 324 15 years and above, female and male wo are on TLD irrespective of tribe National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Lawrence Okello Rafaih
ID:
Evaluation practices and strategy performance of local NGOs in Uganda
REFNo: SS1561ES

4. To determine the relationship between organizational evaluation steering process and strategy performance of NGOs in Uganda,3. To establish the relationship between organizational evaluation technical expertise and strategy performance of NGOs in Uganda,2. To determine the relationship between evaluation planning process and strategy performance of NGOs in Uganda,1. To validate the contextual relevance of organizational effectiveness competency model for strategy evaluation of NGOs in Uganda.,The purpose of this study is to validate the extent to which evaluation practices influence strategy performance of national NGOs in Uganda.,
 Moroto, Moroto
Gulu, Gulu
Kampala, Kampala
Mbarara, Mbarara
Moroto, Moroto
Gulu, Gulu
Kampala, Kampala
Mbarara, Mbarara
Lira, Lira
 Uganda 2022-12-19 12:19:45 2025-12-19 379 In short study targets adult population ( aged between 18-70 years)population from local NGOs who are members of the national NGO forums spread across the country. A total of 40 cluster NGO forums will be engaged to reach our to gather a proportionate sample of about 80 respondents per region. Similarly, Only adult respondents will be included for key informant interviews Lawrence Rafaih Okello Social Science and Humanities Clinical Trial Degree Award
Maxensia owor
ID: UNCST-2021-R014003
 IMPAACT 2036: Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age. Version 1.0, 22 September 2022. DAIDS study protocol ID: 38932
REFNo: HS2599ES

iii. Cohort 2: To describe the maintenance of viral suppression and immunologic activity of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only),iv. Cohort 2: To describe HIV-1 genotypes and phenotypes for children who experience virologic failure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CAB LA + RPV LA (injectable only),ii. Cohort Cohort 2: 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),i. Cohort 2: To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable) and 44 weeks of CAB LA + RPV LA (injectable only),ii Cohort 1: To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oral and injectable) through Week 24,i.Cohort 1: To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable) through Week 24,
 Kampala, all parishes
Wakiso, all parishes
 Uganda 2023-02-13 11:10:13 2026-02-13 90 children and 90 parents/ caregivers worldwide but MUJHU plans to enroll 5 -15 children and 5-15 parents/ caregivers. 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. DAIDS/NIH Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Performance evaluation of the Determine™ HIV Early Detect 4th Generation HIV Rapid Diagnostic test
REFNo: HS2603ES

Primary Objectives:
1. To evaluate the Laboratory performance (Sensitivity and specificity) of the Determine™ HIV Early Detect
2. To assess the field performance of the Determine™ HIV Early Detect in parallel with the Determine™ HIV-1/2 test
Secondary Objective:
1. To assess the effectiveness of the Determine Early Detect to identify acute HIV infection among newly infected individuals

 Buikwe, kawolo
Kampala, Kisenyi
Kampala, Naguru
Mityana, Mityana
Mukono, Mukono hospital
Wakiso, Wagagai
Wakiso, UVRI
Kayunga, Kayunga hospital
Kalungu, Nkozi hospital
Gomba, Gombe hospital
 Uganda 2022-12-23 18:06:59 2025-12-23 10,000 The study will enroll; - Adults above 18 years of age - Willing to have an HIV test. - Eligible for testing as per the National HTS eligibility screening tool - Documented - Abott Diagnostics 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
Winnie  Muyindike R
ID: UNCST-2021-R013558
 Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) – “Promoting Treatment as Prevention”
REFNo: HS2622ES

2. To assess the impact of gabapentin compared to placebo on: a) alcohol consumption; b) pain severity; c) ART adherence; and d) engagement in HIV care, in order to explore potential mechanisms by which gabapentin may lead to HVL suppression.,1. To test the efficacy of gabapentin versus placebo to achieve undetectable HVL (Primary Outcome at 3 months; Secondary Outcome at 6 & 12 months),
 Mbarara, Kamukuzi
Mbarara, Kakoba
 Uganda 2023-01-18 18:33:54 2026-01-18 300 18 years and above, female and male, irrespective of tribe, who are on antiretroviral therapy with detectable viral load and are unhealthy alcohol consumers. National Institute of Health 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
View Sort By:

Our Partners