Henry Mugerwa
ID: UNCST-2019-R000420
|
A Phase 1b, Age De-Escalation/Dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in an African Population of Adults and Children in a Setting of Perennial Malaria Transmission
REFNo: HS5298ES
Primary Objective.
To assess the safety and tolerability of MAM01.
Secondary Objectives.
To assess the safety of MAM01.
To characterize the PK of MAM01 following SC, IV, and IM administration of MAM01.
To assess the formation of anti-drug antibodies (ADAs) to MAM01.
Exploratory Objectives.
To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to a placebo.
To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to placebo.
To assess the protection of MAM01 against events of malaria illness (first/only and all episodes).
To correlate MAM01 concentration with Pf infection risk.
To assess the complexity of Pf infection following administration of MAM01 or placebo.
|
Tororo, Osukuru
Tororo, Kayoro
Tororo, Magola
Kampala, Lubowa
|
Uganda |
2024-12-23 12:23:27 |
2027-12-23 |
139 |
Adults and children, male and female |
Bill & Melinda Gates Medical Research Institute (Gates MRI) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
|
A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5365ES
To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52 week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the Screeening visit
To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period: • VOCs that are HCP-managed at a health care facility • VOCs that are HCP-managed via remote consultation • VOCs that are self-managed without recommendations from HCP during the event • VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
To evaluate the time to first VOC that is HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
|
Eastern Region, All parishes
|
Uganda |
2024-12-23 11:34:49 |
2027-12-23 |
315 |
Participants must be aged 12 years and older on the day of signing informed consent.
Adolescents include participants aged 12 to <18 years old and adults include participants
aged 18 years and older. |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Solomon Kibudde
ID: UNCST-2021-R013747
|
PHASE II RANDOMIZED NON-INFERIORITY TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOR LOCALLY ADVANCED CERVICAL CANCER IN UGANDA.
REFNo: HS5348ES
1) To compare the incidence of grade 3+ gastrointestinal and genitourinary toxicity at 1 year post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) and conventional fractionated radiotherapy (45 Gy in 25 fractions) in women with cervical cancer in Uganda.
2) To evaluate and compare local control and cervical cancer-specific survival rates at 1 year after hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional radiotherapy (45 Gy in 25 fractions).
3) To determine the association between stage-adjusted mean squamous cell carcinoma antigen (SCC-Ag) at 1-month post-treatment with the Progression-free survival at 1- year post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) or conventionally fractionated radiotherapy (45 Gy in 25 fractions).
4) To compare the costs of healthcare to patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).
5) To evaluate patient-reported outcomes and quality of life in patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).
|
Kampala, Mulago
|
Uganda |
2024-12-23 11:01:22 |
2027-12-23 |
120 participants |
To be considered eligible for this study, participants must meet the following criteria:
1. Females aged 18 years or older
2. Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment.
3. FIGO 2018 Stage IB3, IIA, IIB, IIIA, IIIB, IIIC, or IVA.
4. Able to provide written informed consent in English, Luganda, Runyankole, Lango or Lusoga.
5. Willing to attend post-treatment follow-up for up to 12 months.
6. Fit for concurrent chemotherapy with cisplatin.
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
8. Adequate bone marrow function: Absolute neutrophil count ≥ 1,500 cells/mm3 (1.5 x 109/L); Platelets ≥ 100,000 cells/mm3 (100 x 109/L); haemoglobin ≥ 9.0 g/dL; Leukocyte count ≥ 4,000 cells/mm3 (4.0 x 109/L).
9. Adequate renal function: creatinine clearance > 60 mL/mins, calculated using the Cockcroft-gault equation for women.
10. Adequate liver function: AST and ALT < 3 times the upper limit of normal (ULN); and Total bilirubin < 2 x ULN unless attributed to the use of antiretroviral therapy (ART).
Exclusion criteria
Participants will be excluded from the study if they meet any of the following criteria:
1. Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention.
2. Clinical and/or radiological evidence of distant metastases.
3. Prior pelvic or abdominal radiotherapy.
4. Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment.
5. History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment.
6. Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated.
7. Concurrent untreated invasive malignancy
8. Uncontrolled concurrent medical/psychiatric diagnosis that would limit compliance with study requirements
|
Uganda Cancer Institute, Varian Medical Systems, and UCI-FHCC |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Jackson Orem
ID: UNCST-2021-R012016
|
A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings
REFNo: HS4073ES
To describe the incremental cost-effectiveness ratio per QALY gained (as assessed by PROPr) between PLD and PTX,To assess quality of life across PROMIS domains (i.e., cognitive function, physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with the PROPr tool at start of therapy, mid-treatment, and after treatment with PLD and PTX ,To describe the cost of therapy across AMC sites in sub-Saharan Africa to deliver both PLD and PTX by micro-costing analysis for goods and time-in-motion analysis for services. ,To estimate the objective response rate (defined as the sum of complete and partial responses) for AIDS-KS, response duration and overall survival in each treatment arm. ,To evaluate whether there is sufficient evidence to conclude that PLD is non-inferior to PTX in people with severe AIDS-associated KS receiving concomitant ART in resource-limited settings. ,
|
Kampala, Mulago
|
Uganda |
2024-12-10 14:39:24 |
2027-12-10 |
130 participants overall and up to 40 participants in Uganda |
This study will be done in adults above 18 years, both male and female of all tribes, and will recruit participants with HIV-associated Kaposi Sarcoma in Uganda. |
AIDS Malignancy Consortium |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2021-R013577
|
Open-label, Multicenter Immunogenicity and Safety Trial of MVA-BN® Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections
REFNo: HS5281ES
To assess immunogenicity of the MVA-BN standard regimen in eliciting neutralizing antibodies against vaccinia virus in children compared to adults.
To assess the safety and reactogenicity of the MVA-BN standard regimen in children and adults.
To assess neutralizing antibody response to the MVA-BN standard regimen.
To assess durability of neutralizing antibody response to the MVA-BN standard regimen.
|
Wakiso, Entebbe
Mbarara, Mbarara
|
Uganda |
2024-11-22 17:19:29 |
2027-11-22 |
300 Participants |
The trial population for this trial will be both pediatric (2 to <12 years of age) and adult (18 to 50 years of age) healthy volunteers. Both males and females will be recruited at the research sites in Entebbe and Mbarara. Potential volunteers will be approached in their communities, given information about the trial and those who show interest will be requested to come to the research sites. |
Bavarian Nordic A/S and funded by the Coalition for Epidemic Preparedness Innovations (CEPI). |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
| View |
|
Sort By: |
|
|
|
| |
|
