Jackson Mukonzo
ID: UNCST-2021-R013916
|
Safety of COVIDEX™ Therapy in adults: in Uganda: A randomized controlled open-
label phase 1 clinical trial.
REFNo: HS6540ES
Overall aim
To validate the safety of COVIDEX™ therapy in adult Ugandans.
Specific objectives
Primary objective
To evaluate and document adverse events associated with COVIDEX™ among adults
in Uganda.
Secondary objective:
To determine the plasma concentration of berberine in adults receiving COVIDEX™ at
three different dose levels.
|
Kampala,
|
Uganda |
2025-11-21 14:11:01 |
2028-11-21 |
72 |
Study participants shall be healthy
adult volunteers of 18years and above |
JENA HERBALS LIMITED |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Eugene Ruzagira
ID: UNCST-2023-R008282
|
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to
Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure
Prophylaxis in Women
REFNo: HS6565ES
To evaluate the efficacy of MK-8527 qm
compared to FTC/TDF qd for the
prevention of HIV-1 infection as assessed
by the incidence rate per year of adjudicated
HIV-1 infections
To evaluate the safety and tolerability of
MK-8527 qm compared to FTC/TDF qd.
|
Masaka, Masaka
|
Uganda |
2025-11-21 11:18:30 |
2028-11-21 |
150 |
This study includes participants of varying age, race, ethnicity, and sex, female at birth, Aged from 16 years to 30 years of age inclusive, at the time of providing the informed consent or assent and Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during
screening.
|
Merck Sharp & Dohme LLC |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
ERIC WOBUDEYA
ID: UNCST-2019-R001047
|
Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age with and without HIV
REFNo: HS6555ES
Primary Objectives
Cohort 1 and Cohort 2
• To determine the weight-band dosing of RPT taken as part of the 1HP regimen by evaluating:
⎯ PK RPT exposures among children with and without HIV
⎯ Safety and tolerability of the 1HP regimen among children with HIV while receiving twice-daily DTG and children without HIV through 28 days of dosing
Cohort 2
• To evaluate the effect of RPT taken as part of the 1HP regimen on the PK of DTG
Secondary Objectives
Cohort 1 and Cohort 2
• To evaluate the effect of covariates including age, weight, sex, ethnicity, nutritional status, and HIV-1 status on the PK of RPT taken as part of the 1HP regimen
• To evaluate the safety of the 1HP regimen through 24 weeks of follow-up
• To evaluate the palatability and acceptability of the 1HP regimen
• To evaluate adherence to the 1HP regimen
Cohort 2
• To evaluate the safety and tolerability of twice-daily DTG through 42 days among children with HIV who are receiving 1HP
• To evaluate virologic control (less than 200 copies/mL) at Day 42 among children taking a DTG-based ARV treatment regimen co-administered with 1HP
|
Kampala, mulago
|
Uganda |
2025-11-04 12:59:17 |
2028-11-04 |
40 |
children living without HIV (Cohort 1) and children living with HIV (Cohort 2) at risk of TB disease who are less than 13 years of age. |
National Institute of Allergy and Infectious Diseases Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Mental Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Henry Mugerwa
ID: UNCST-2019-R000420
|
A5402 An Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV
REFNo: HS6604ES
1.2 Primary Objectives
1.2.1 To compare pramipexole to escitalopram in the treatment of MDD (and comorbid MDD with MND) based on the Beck Depression Inventory-II (BDI-II/BDI-2) total score [Beck 1996] from baseline to week 24.
1.2.2 To evaluate the safety of pramipexole and escitalopram in PWH having MDD (and comorbid MDD with MND) from baseline to week 24.
1.3 Secondary Objectives
1.3.1 To compare pramipexole to escitalopram in the treatment of MDD using MDD caseness, neurocognitive outcomes, and functional status from baseline to week 24.
1.3.2 To compare the depression, neurocognitive, and functional status outcomes in PWH with MDD alone and with comorbid MDD with MND treated with pramipexole versus escitalopram from baseline to week 24.
1.3.3 To compare the impact of pramipexole and escitalopram on all outcomes above by female versus male sex (assigned at birth) from baseline to week 24.
1.3.4 To determine the impact of pramipexole compared to escitalopram on the measure of HIV-1 RNA viral load in the peripheral blood.
1.4 Exploratory Objectives
1.4.1 To characterize associations between escitalopram trough concentrations and treatment efficacy (BDI-II/BDI-2 total score) as well as participant adverse events (adverse event frequency, severity, and discontinuation rates).
1.4.2 To characterize associations between escitalopram trough concentrations and genetic polymorphisms that affect metabolizing enzymes of escitalopram (known metabolizing enzymes include CYP2C19, CYP2D6, and CYP3A4).
1.4.3 To explore associations between cerebrospinal fluid (CSF) concentrations of escitalopram and BDI-II/BDI-2 total score.
1.4.4 To evaluate adverse events potentially related to drug interactions between antiretroviral therapy (ART) and escitalopram and pramipexole, respectively.
1.5 Substudy Objective
1.5.1 CSF Substudy
To compare the impact of pramipexole and escitalopram on biomarker outcomes in a CSF substudy of participants with MDD alone.
|
|
Uganda |
2025-10-29 16:04:25 |
2028-10-29 |
50 |
PWH having a diagnosis of MDD alone or with comorbid MDD and MND
· ≥18 to ≤70 years old both male and female.
People who understand English and Luganda because the site informed consent forms only in Luganda and English |
National Institute of Allergy and Infectious Diseases and CIPLA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Abel Kakuru
ID: UNCST-2022-R009193
|
Dihydroartemisinin-piperaquine plus sulfadoxine-pyrimethamine versus sulfadoxine-pyrimethamine alone for the prevention of febrile illnesses in children with sickle cell anemia: a double-blind randomized controlled trial
REFNo: HS6294ES
1.
To compare the incidence of all-cause febrile illness among children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
2.
To compare the incidence of adverse events among children with sickle cell anemia randomised to receive monthly SP vs. monthly DP+SP.
3.
To compare the prevalence of markers of antimalarial resistance, including those associated with SP and DP resistance, among parasitemic children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
|
Busia, Selected parishes
|
Uganda |
2025-10-29 15:55:44 |
2028-10-29 |
232 children with sickle cell anemia |
Aged 2-10 years children with sickle cell anemia |
Thrasher Research Fund |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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