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 |
|
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
|
A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and
antiviral effect of S-217622 compared with placebo in non-hospitalized participants with
COVID-19
REFNo: HS2642ES
The main intent of the study is to evaluate the efficacy of S-217622 vs. placebo. The study will be conducted in the setting of the locally available standard-of-care COVID-19 treatment. High-risk and low-risk participants will be analyzed together for the primary analysis and separately for secondary analyses. The following primary, secondary, and exploratory objectives will be addressed in the modified intent-to-treat (mITT) population, except for the safety analyses, which will be analyzed in the Safety population, and pharmacokinetic (PK) analyses, which will be analyzed in the PK population.
|
Tororo, All Parishes
|
Uganda |
2023-02-06 17:17:04 |
2026-02-06 |
Each site in Uganda will (through competitive enrolment) enroll at least 8 participants making a total of 32 participants for all Uganda sites. |
Outpatient adults (≥18 years) with: a) documented positive
SARS-CoV-2 nucleic acid or antigen test from a sample
collected ≤120 hours (5 days) prior to randomization, b) onset
of symptoms of COVID-19 ≤5 days prior to randomization,
c) presence of 1 or more select COVID-19 symptoms within
24 hours prior to randomization. Participants will be eligible
regardless of vaccination status and will be classified as either
high risk or low risk.
High-risk participants: defined as aged ≥65 years or those with
presence of high-risk conditions.
|
National Institute of Allergy and Infectious Diseases (NIH), Division of AIDS (DAIDS) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
|
A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants.
REFNo: HS2646ES
The primary objective of this study is to confirm the dose of ATV/co or DRV/co in HIV-1 infected pediatric participants, to confirm the dose of F/TAF in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
|
Mityana, Mityana
Mubende, Mubende
Masaka, Masaka
Rakai, Kalisizo
Kampala, Kampala
Wakiso, Entebbe
|
Uganda |
2023-03-09 23:33:04 |
2026-03-09 |
15 |
The study will be conducted in young children and adolescents aged 3 to < 18 years; HIV-1 infected on a stable antiretroviral regimen for a minimum of 3 months. In Uganda, the study will be conducted by researchers from the coordinating site, MU-JHU Research Collaboration, MU-JHU CARE – Kampala, Uganda, in collaboration with Africa Medical and Behavioral Sciences Organization (AMBSO) – Kampala and SICRA-TASO MULAGO National Referral Hospital, Masaka, Uganda. |
Gilead Sciences Inc |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
|
PHASE 2C CLINICAL TRIAL OF NOVEL, SHORT-COURSE REGIMENS FOR THE TREATMENT OF PULMONARY TUBERCULOSIS:
CRUSH-TB (Combination Regimens for Shortening TB Treatment)
REFNo: HS2650ES
Primary objective
(1) To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in liquid media.
Secondary objectives
(1) To compare the proportion of participants with a grade 3 or higher adverse event in each experimental arm with the control arm
(2) To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up to 52 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
(3) To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in solid media
(4) To compare the proportion of participants in each arm who convert liquid and solid sputum cultures to negative by (a) 8 weeks of treatment and (b) 12 weeks of treatment
(5) To describe the rate of all-cause study drug discontinuation in each arm
(6) To compare time to sputum culture positivity curves through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960) across arms
(7) To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up up to 78 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
(8) To describe the population PK of bedaquiline and its M2 metabolite, with or without rifabutin co-administration (PK#1)
(9) To conduct pharmacokinetic/pharmacodynamics study of the test drugs to determine relationships between pharmacokinetic parameters (AUC, Cmax) and outcome measures (time to culture negativity or rate of change in TTP) using non-linear mixed effects models, adjusting for key covariates that may affect outcomes (e.g. companion drugs, HIV status, cavitary disease) (PK#2)
|
Kampala, Mulago
|
Uganda |
2023-02-21 13:13:53 |
2026-02-21 |
288 overall, 100 in Uganda |
This will be a multisite international study. Male and female participants who are age 12 or older and have suspected or proven pulmonary tuberculosis will be enrolled into the study.
Enrollment will be open to all TBTC sites willing to participate and who have completed trial start-up requirements.
Target enrollment is at least 288 participants (96 participants per arm).
Pregnant or breast-feeding individuals will be excluded from the study because of uncertainties about the safety of bedaquiline, delamanid, and moxifloxacin in these groups. The sex, ethnicity, and socioeconomic background of study participants are expected to mirror those of the populations served by local tuberculosis clinics and the populations most affected by tuberculosis worldwide.
Co-enrollment in other therapeutic clinical trials is not allowed.
|
U.S. Centers for Disease Control and Prevention |
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 |
|
Timothy Muwonge Ronald
ID: UNCST-2020-R014680
|
Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV
REFNo: HS2935ES
To estimate the programmatic cost and budget impact of implementing the Head StART intervention in refugee settlements in Uganda. ,To assess Head StART implementation across refugee settlement sites to understand the impact of contextual factors on study outcomes. ,To evaluate the effectiveness of “Head StART,” the expansion of community ART delivery to people newly diagnosed with HIV, in achieving HIV viral suppression in refugee settlements in Uganda. ,The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.,
|
|
Uganda |
2024-01-05 9:11:58 |
2027-01-05 |
1200 |
We will recruit adult persons living with HIV aged 18 and above and accessing care from health care centers in refugee camps in Uganda. |
National Institute of Health |
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Adoke Yeka
ID: UNCST-2021-R004300
|
Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 plus Pyronaridine Administered once Daily for 1 or 2 Days to Adults and Adolescents with Acute Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2736ES
To evaluate the safety and
tolerability of the M5717-
pyronaridine combination in
adult participants with acute
uncomplicated malaria due to
P. falciparum.
Secondary.
o describe the clinical efficacy
of the M5717-pyronaridine
combination in adult participants
with acute uncomplicated
malaria due to P. falciparum
|
Tororo, Central
|
Uganda |
2023-03-16 12:35:56 |
2026-03-16 |
200 |
Participants Are ≥ 12 and ≤ 55 years of age (≥ 18 and ≤ 55 years of age for
Part A) at the time of signing the informed consent.
Type of Participant
and Disease
Characteristics:
2. Microscopic confirmation of acute uncomplicated
P. falciparum using Giemsa-stained thick and thin film.
3. P. falciparum parasitemia of ≥ 1,000 to ≤ 50,000 asexual
parasites/µL of blood in Part A and P. falciparum parasitemia
of > 1,000 to ≤ 150,000 asexual parasites/µL of blood in Part B.
4. Axillary temperature ≥ 37.5ºC or tympanic temperature
≥ 38.0ºC (use as per COVID-19 protocols at the site [only at
Screening]), or history of fever during the previous 24 hours (at
least documented verbally).
Weight: 5. Have a body weight ≥ 24 kg |
Merck Healthcare KGaA, Darmstadt, Germany an affiliate of Merck KGaA, Darmstadt, Germany Frankfurter Str. 250 64293, Darmstadt, Germany |
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 |
|
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 |
|
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 |
|
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 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 |
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|
Nazarius Tumwesigye Mbona
ID: UNCST-2019-R000664
|
WEB-BASED INTERVENTION FOR ALCOHOL AND SUBSTANCE ABUSE AMONG YOUNG UNIVERSITY STUDENTS
REFNo: SS1785ES
To assess feasibility and effectiveness of the web-based intervention for prevention and treatment of ASUD problems among youth 18-24 years attending Universities in Uganda,To develop a web-based intervention for prevention and treatment of ASUD problems among youth 18-24years attending Universities in Uganda,To establish the prevalence of ASUD problems among youth 18-24years in selected Universities,To contribute to the improvement of the quality of ASUD treatment services in Uganda among the youth through the development of a web-based intervention and assess its feasibility and effectiveness for the prevention and treatment of ASUD among University students in Uganda,
|
Kampala, Mulago
Mpigi, Nkozi
|
Uganda |
2025-09-09 8:17:25 |
2028-09-09 |
5000 |
Any student aged 18 – 24 years at any level of education from the following universities: Makerere University, Kyambogo University, Makerere University Business School (semi-independent public entity), Uganda Christian University, Uganda Martyrs University Nkozi, Kampala International University (KIU) and Ndejje University. |
Government of Uganda |
Social Science and Humanities |
Clinical Trial |
Non-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 |
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