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 |
|
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 |
|
Raymond Tweheyo
ID: UNCST-2020-R014507
|
Understanding the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda - a quasi experiment
REFNo: HS2689ES
General objective: To understand the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda.
Specific objectives:
1. To determine the optimal performance based financial incentive incentive's structure required for improving the performance, motivation and retention of CHWs.
2. To explore the acceptability and perceptions of potential sustainability of CHWs financial compensation structure to various stakeholders, including the CHWs, and the CHW supervisors at the district and Ministry of Health.
3. To explore the perceived value and impact of financial incentives on CHW's job satisfaction, personal income and livelihood.
|
Wakiso, all parishes
Mpigi, all parishes
Mbale, all parishes
Jinja, all parishes
|
UK |
2023-03-07 10:40:31 |
2026-03-07 |
3,215 children under five, 720 Community Health Workers, 32 Key Informants |
1. Women of reproductive age (18 to 49 years) who have a child under five years of age.
2. Community Health Workers (18 years and above)
3. Adult Key Informants - district, Ministry of Health and Implementing Partner officials |
USAID/ Living Goods |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Rachel Brathwaite
ID:
|
Assessing the Feasibility of Economic Approaches to Prevention of Substance
Abuse among Adolescents
REFNo: HS2683ES
Aim 1. Examine the prevalence and consequences of ADU in a cohort of 200 AYLHIV (ages 18-24) seen at six (6) HIV clinics in southwestern Uganda.
Aim 2. Using a mixed methods approach, identify the multi-level (individual, interpersonal, community and structural) factors associated with ADU among AYLHIV.
Aim 3. Using a subset of the sample, explore the feasibility and short-term effects of a family-based economic empowerment intervention on ADU among AYLHIV.
|
Masaka,
|
Trinidad and Tobago |
2023-03-02 15:32:31 |
2026-03-02 |
230 |
220 Adolescents and youths living with HIV aged 18-24 years. 10 healthcare providers aged >18 years. |
National Institute on Alcohol Abuse and Alcoholism |
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 |
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