Francis Ssali
ID: UNCST-2021-R012134
|
A Phase 2, Open-label, Single-arm, Multicentre Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to less than 12 years) who are Virologically Suppressed (TMC278HTX2002)
REFNo: HS1815ES
Primary Endpoints
• Area under the plasma concentration-time curve from the time of administration up to 24 hours post-dose of RPV, as derived from the intensive PK assessments.
• Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.
Secondary Endpoint
• Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment.
• Change from baseline Movement.
• Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment.
• Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment.
|
Wakiso, Makindye
,
|
Uganda |
2021-11-22 |
2024-11-22 |
lower limit is 3 and Upper limit is 10 |
Participants (boys and girls) aged ≥2 to <12 years with a bodyweight of at least 11 kg |
Janssen Sciences Ireland Unlimited Company |
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 |
|
Francis Ssali
ID: UNCST-2021-R012134
|
A5409: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
REFNo: HS4036ES
1.2 Primary Objectives
1.2.1 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.
1.2.2 To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.
1.3 Secondary Objectives
1.3.1 To compare time to stable culture conversion by MGIT liquid culture by week 8 for each experimental treatment arm to the SOC arm.
1.3.2 To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.
1.3.3 To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for each experimental treatment arm to the SOC arm.
1.3.4 To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26 weeks of treatment for each experimental treatment arm to the SOC arm.
1.3.5 To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.
1.3.6 To compare a composite of efficacy and safety outcomes using a risk-benefit approach for each experimental treatment arm to the SOC arm.
1.3.7 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.
1.3.8 To compare durable cure by 52 weeks after treatment initiation in each experimental treatment arm to the SOC arm.
|
Kampala, Kampala
Wakiso, Wakiso
|
Uganda |
2024-12-23 12:34:14 |
2027-12-23 |
45 participants in each experimental treatment arm and at least 90 participants in the SOC arm. The JCRC site plans to recruit at least 50 participants |
Participants with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. |
National Institute of Allergy and Infectious Diseases (NIAIDS) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Grace Kisitu Paul
ID: UNCST-2024-R004102
|
UNIVERSAL1: Pharmacokinetic study of an optimized dose ratio of
dolutegravir/emtricitabine/tenofovir alafenamide fumarate: expediting a UNIVERSAL first line regimen for all children living with HIV in Africa
REFNo: HS4280ES
Primary objective:
To evaluate the pharmacokinetics and short-term safety of DTG and FTC/TAF administered to children living with HIV using a novel dose ratio
Secondary objective:
To evaluate the short-term efficacy of DTG and FTC/TAF
formulations in children using a novel dose ratio
|
|
Uganda |
2024-07-19 3:45:20 |
2027-07-19 |
50 |
Children aged between 28 days and ≤10 years old weighing ≥3 to <25kg diagnosed with HIV.
|
Fondazione Penta ETS |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Grace Kisitu Paul
ID: UNCST-2024-R004102
|
Universal2: Pharmacokinetics, safety and acceptability of a solid paediatric fixed-dose combination of darunavir/ritonavir (DRV/r) 120/20mg for children living with HIV
REFNo: HS4762ES
To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg
To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to Less than 25 kg
To evaluate the acceptability of DRV/r tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg
To evaluate the short-term efficacy of the DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg
To describe RTV PK parameters as well as darunavir unbound plasma concentrations.
|
|
Uganda |
2024-08-22 11:45:22 |
2027-08-22 |
50 |
Children with HIV, from 3 years of age, requiring DRV/r:
• weighing 10 to less than 25 kg with 1 or 2 DRV resistance-associated mutations (RAM) *
Or
• weighing 10 to less than 20 kg requiring DRV/r, with no DRV RAM*
*DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V
|
Fondazione Penta ETS |
Medical and Health Sciences |
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 |
|
Gorretti Nassali
ID:
|
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
REFNo: HS2133ES
Primary objective:
To demonstrate superiority of giredestrant over the control treatment
Secondary objectives:
1. To evaluate the efficacy of giredestrant compared with TPC
2. To evaluate the safety of giredestrant compared with TPC
3. To characterize giredestrant pharrmacokinetics (PK)
4. To evaluate health status utility scores of participants treated with giredestrant compared with TPC
5. To evaluate the efficacy of giredestrant compared with TPC
6. To evaluate the tolerability of giredestrant compared with TPC
7. To identify and/or evaluate biomarkers that are predictive of response to giredestrant
|
Kampala, mulago
|
Uganda |
2022-09-06 14:14:37 |
2025-09-06 |
Approximately 4700 participants will be screened to achieve random assignment in 1:1 ratio to study treatment of 4100 randomized participants for an estimated total of 2050 randomized participants per |
Approximately 4100 participants with medium- and high-risk Stage I?III histologically confirmed ER? and HER2? EBC will be enrolled during the global enrollment phase of this study. After completion of the global enrollment phase, additional participants |
F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel, Switzerland |
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 |
|
Herbert Ainamani Elvis
ID: UNCST-2020-R014674
|
The Impact of Self Help Plus and Climate Smart Agriculture on Mental Health and Food Security in the Rhino and Nakivale Refugee Settlements of Uganda
REFNo: HS4691ES
To compare the uptake of HGI between the mothers in the combined intervention group (HGI & SH+) with those in the HGI group living in Nakivale refugee settlement,To assess the effect of SH+ on the development of children aged 3-6 years belonging to participating mothers living in Rhino and Nakivale refugee settlements,To assess the effect of SH+ on the mental health of mothers with children aged 3-6 years living in Rhino and Nakivale refugee settlements ,To assess the perceptions and attitudes towards a home gardening intervention (HGI) among participating mothers living in Nakivale refugee settlement,To assess the effectiveness of Self Help Plus (SH+) and home gardening on maternal mental health, food security and child development in the Rhino and Nakivale refugee settlements of Uganda,
|
|
Uganda |
2024-08-26 14:58:27 |
2027-08-26 |
900 |
The target population of the proposed research project consists of refugee mothers (age 18+) with children aged 3-6 years, living in the Nakivale and Rhino refugee camps in Uganda.
In Nakivale, the study will recruit 900 mother-child dyads across 30 villages, while in Rhino, 720 dyads from 24 villages will participate. Participating mothers in randomly selected intervention villages will be the recipients of the mental health and/or smart farming intervention. Outcomes will be measured at the level of the mother, the child, and the household.
|
Uppsala University |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Harriet Ajilong
ID: UNCST-2022-R005889
|
Assessing Vitamin D serum levels in HIV-positive adolescents 10-19 years with depression in Northern Uganda
REFNo: HS3454ES
To determine the burden of depression in HIV-positive adolescents at Gulu RRH,To assess for serum Vitamin D levels in HIV Positive adolescents 10-19 years with depressive symptoms in Gulu Regional Referral Hospital Methods,
|
Gulu, Laroo
|
Uganda |
2024-01-24 22:30:43 |
2027-01-24 |
380 participants |
HIV Positive adolescents at Gulu Regional Referral Hospital |
Child Global Research Fellowship |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Haruna Muwonge
ID: UNCST-2019-R000128
|
A Randomized, Double-Blinded, Placebo-Controlled, Phase III, Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above
REFNo: HS2185ES
Safety: To evaluate adverse events from the first dose and the booster dose to Day 28 after the whole-course immunization and serious adverse events from the first dose and the booster dose to at least 12 months after the whole-course immunization,Efficacy: To evaluate the efficacy of the SARS-CoV-2 Vaccine, Inactivated (Vero Cell) for symptomatic and laboratory-confirmed (RT-PCR method) COVID-19 cases caused by different SARS-CoV-2 variants,Immunogenicity: To evaluate the immune persistence of the investigational vaccine,Immunogenicity: To demonstrate the consistency of 3 lots of investigational vaccine in terms of GMT 14 days after the whole-course immunization,Immunogenicity: To evaluate the levels of neutralizing antibody and IgG antibody against SARS-CoV-2 14 days after the whole-course and after the booster immunization,Efficacy: To evaluate the efficacy of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) against symptomatic and laboratory-confirmed (RT?PCR method) severe COVID-19 disease,Efficacy: To evaluate the efficacy of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) after at least one dose, 2 doses, and after the booster dose of immunization,To evaluate the efficacy, safety and immunogenicity of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after a 2-dose schedule, and after booster vaccination,
|
Kayunga, Ntenjeru
Jinja, Nakasero
Mityana, Central Ward
Mubende, Kyaterekera
Gulu, Agwee
Wakiso, Central Ward
Mukono, Ggulu Ward
Kampala, Mulago I
|
Uganda |
2022-04-07 |
2025-04-07 |
5000 |
Adults 18years and above, male and female, all tribes that fulfill the study inclusion criteria |
Institute of Medical Biology Chinese Academy of Medical Sciences |
Medical and Health Sciences |
Clinical Trial |
Non-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 |
|
Helen Byakwaga
ID: UNCST-2019-R001168
|
A Phase III/IV factorial randomised double-blind trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin/ezetimibe versus pitavastatin, in patients with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk (Optimising metabolic management on integrase-based antiretroviral therapy – the OPTIMAR Study)
REFNo: HS5819ES
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on: fasting lipids, cardiovascular disease risk assessment measures; inflammatory biomarkers; and safety and tolerability,To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on: intermediate markers of cardiovascular disease risk; cardiovascular disease risk assessment measures; clinical consequences of increased body weight; and safety and tolerability of dapagliflozin,To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on LDL concentration change from baseline to week 24,To assess the impact of dapagliflozin vs. placebo on absolute weight change from baseline to week 24,The overall objective of the study is to examine the impact of dapagliflozin vs. placebo on metabolic parameters in PWH with high metabolic risk who are on INSTI-based ART.,
|
Kampala, Mulago I
|
Uganda |
2025-09-30 14:11:23 |
2028-09-30 |
30 at the Infectious Diseases Institute Kampala |
All adults aged 40-75 years, both female, all tribes will be included. |
The Kirby Institute |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Herbert Kayiga Kayiga
ID:
|
EFFECTIVENESS, ACCEPTABILITY AND UPTAKE OF EARLY VERSUS STANDARD INTRAUTERINE CONTRACEPTION FOLLOWING PROVISION OF FIRST TRIMESTER MEDICAL POST ABORTION CARE IN CENTRAL UGANDA
REFNo: HS2111ES
1. To determine the proportion of women who take up IUC after mPAC for 1st trimester incomplete abortion.
2. To compare the expulsion rates at six months between early versus standard IUC insertions post mPAC treatment for first trimester incomplete abortion.
3. To compare the IUC continuation rates at six months between early versus standard IUC insertion post mPAC treatment for first trimester incomplete abortion.
4. To explore the women and their spouses' perception on Long Acting Reversible Contraceptives (LARC) and IUC following mPAC treatment.
5. To explore the Healthcare providers' perception on LARC and IUC following mPAC treatment.
|
Wakiso, Kasangati
Kampala, Namirembe
Buikwe, Kawolo
Mpigi, Mpigi
Luweero, Luweero
Mukono, Kawolo
Masaka, Masaka
Mityana,
Kayunga,
Gomba,
|
Uganda |
2022-05-10 9:21:09 |
2025-05-10 |
2076 |
Women with first trimester incomplete abortion irrespective of tribe and nationality undergoing medical management will receive written and oral information about the study from the attending physician according to the principles of the Helsinki Declarati |
Prof Kristrina Gemzell |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Hannah Kibuuka
ID: UNCST-2020-R014355
|
A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older
REFNo: HS1638ES
1. To assess, in participants who are SARS-CoV-2 naïve, the
clinical efficacy of the CoV2 preS dTM-AS03 vaccines for
the prevention of symptomatic COVID-19 occurring ≥ 14
days after the second injection.
2. To assess the safety of the CoV2 preS dTM-AS03 vaccines
compared to placebo throughout the study.
|
Kampala,
Wakiso,
Mukono,
|
Uganda |
2021-08-10 |
2024-08-10 |
800 |
Adults 18 years of age
and older |
Sanofi Pasteur Inc. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Hannah Kibuuka
ID: UNCST-2020-R014355
|
A randomized, double-blind, positive-controlled Phase III clinical trial to
evaluate the efficacy and safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in population previously unvaccinated with COVID-19 vaccine and aged ≥18 years
REFNo: HS2508ES
To evaluate the protective efficacy of SCTV01E against symptomatic COVID-19 occurring from 14 days after the 2nd dose in population
previously unvaccinated with COVID-19 vaccine.
To evaluate the protective efficacy of SCTV01E against symptomatic COVID-19 occurring from 7 days after the 3rd dose in population previously unvaccinated with COVID-19 vaccine
|
Kampala, Nakasero
Wakiso, Central
|
Uganda |
2022-10-28 15:05:42 |
2025-10-28 |
2000 |
Individuals previously unvaccinated with COVID-19 vaccine and aged
≥18 years |
Sinocelltech Ltd |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Hannah Kibuuka
ID: UNCST-2020-R014355
|
PROTECT-APT 1 _ Master Protocol for Early Treatment and Post-Exposure Prophylaxis of COVID-19 Adaptive Platform Trial V3.0 dated 02 June 2023 and Appendix C entitled “A phase 2 safety and efficacy study of upamostat for early outpatient treatment of COVID-19” V3.0 dated 01 June, 2023
REFNo: HS3116ES
To determine if early treatment with upamostat can shorten time to sustained symptom alleviation or resolution in participants infected with SARS-CoV-2.
|
Kabarole, Baza
|
Uganda |
2024-06-24 0:12:16 |
2027-06-24 |
40 |
Adult male and female participants aged 18 years and above |
FHI Clinical |
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 |
|
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 |
|
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
|
Six weeks of daily Rifapentine vs. a comparator arm of 12-16 week Rifamycin-based treatment of latent M. tuberculosis infection: Assessment of safety, tolerability, and effectiveness
REFNo: HS3492ES
The main objective of this trial is to compare the safety and effectiveness of a six-week regimen of daily Rifapentine to that of a standard arm of 12weeks of HP or 12 weeks of H or 16 weeks of R for the treatment of LTBI
|
Kampala, Mulago
|
Uganda |
2023-12-21 20:31:51 |
2026-12-21 |
The target total enrollment is 3400 participants from all participating sites and approximately 250 participants will be enrolled from the Ugandan site |
The target study population will include male and female (except pregnant or breast-feeding) participants aged 12 years or older with LTBI who do not have evidence of active disease and are at increased risk of progression to active TB. |
U.S. Centers for Disease Control and Prevention |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
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