Irene Andia Biraro Rebecca
ID: UNCST-2019-R001475
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A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People with Diabetes.
REFNo: HS1112ES
Primary objective:
To assess the efficacy of preventive therapy with a 12-week course of rifapentine and isoniazid (3HP) against the development of probable or definite TB disease over 24 months in people with Diabetes Mellitus (DM) who are latent TB infection (LTBI) test positive.
Secondary objectives:
• To assess the efficacy of 3HP against the development of possible, probable or definite TB disease over 24-40 months in people with DM who are latent tuberculosis infection test positive
• To compare the proportions who complete treatment between arms
• To compare the occurrence of adverse events between arms
• To compare the rate of TB or death between arms
• To compare the overall mortality rate between arms
• To explore the efficacy of 3HP against development of probable or definite TB in those who are LTBI test positive, across the following sub-groups, separately: study site (n=3); age groups; duration of DM; level of glycaemic control (baseline HbA1C) and body mass index (BMI).
• To assess the efficacy of 3HP against development of probable or definite TB, in two restricted analyses: TST positive and IGRA positive participants.
• To carry out sub-studies including i) an economic modelling and cost effectiveness study, ii) a cohort study of those who are IGRA and TST negative a baseline, iii) a cross-sectional study of HIV and TB prevalence and DM phenotype, (iv) evaluation of point-of care (POC) testing for LTBI, and computer-assisted X-ray, (v) a public health study of patient management, and v) future genetic studies.
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Kampala, Munyonyo
Wakiso, Kasangati
Kampala, Rubaga
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Uganda |
2021-06-18 |
2024-06-18 |
1500 |
Inclusion criteria
I. Enrolled in diabetes care with a history of DM and current use of anti-diabetic medication (‘known DM’); OR in the absence of anti-diabetic medication an HbA1c of ≥6.5% (48 mmol/mol) or a fasting venous plasma glucose of ≥7. |
National Institute for Medical Research, Mbeya Tanzania |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Julius Okuni Boniface
ID: UNCST-2019-R000963
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A MULTI-COUNTRY, SINGLE-BLINDED, PHASE 2 STUDY TO EVALUATE RAPID DETECTION SYSTEMS OF SARS-COV-2
REFNo: HS1425ES
1. To determine the clinical sensitivity of the test assays compared to the real-time RT-PCR-based method.
2. To determine the specificity of the test assays compared to the real-time RT-PCR-based method.
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Kampala, Mulago
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Uganda |
2021-06-16 |
2024-06-16 |
500 |
The age group will be adults from 18 years and above. The samples will be collected from archives at the Biorepository in the Department of Immunology and Molecular Biology, Makerere University. The samples will be from people from patients that had compl |
EDCTP |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Musa Sekikubo
ID: UNCST-2021-R014010
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A multi-Centre, randomised, placebo controlled, double-blind, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine (GBS-NN/NN2) in women who are pregnant and living with HIV and women who are pregnant and do not have HIV
REFNo: HS1390ES
Objectives
Primary Objectives:
Safety:
To evaluate the safety and tolerability of the GBS-NN/NN2 vaccine in women living with HIV and women without HIV and their newborn babies from vaccination up to delivery/birth.
Immunological:
To compare the transfer rate of vaccine- specific immunoglobulin G (IgG) antibody concentrations from the mother to the baby at birth in women living with HIV with the transfer rate in women without HIV. This endpoint will be used to determine the sample size calculation.
Secondary Objectives
Safety: The safety and tolerability of the GBS-NN/NN2 vaccine in the mother and baby over the first 6 months post-partum, as assessed at 6 months of age.
Immunological: The secondary immunological objectives are:
• To compare IgG antibody responses, specific to the GBS-NN/NN2 vaccine, induced by the first and second vaccine doses over time in pregnant women living with HIV and pregnant women without HIV.
• To evaluate the concentration of IgG antibodies specific for the GBS-NN/NN2 vaccine up to 6 months post-delivery in the mother and baby in women with and without HIV.
• To determine the concentrations of vaccine specific IgG to GBS-NN/NN2 in cord blood at delivery in babies born to women with and without HIV.
Exploratory Objectives
• To compare between groups the isotype composition of the vaccine specific antibodies; in particular IgG and IgA as well as their subclasses, i.e. IgG1-4, IgA1 and IgA2 in maternal and cord blood.
• To compare between groups the vaccine specific IgG antibodies to Rib, Alp1, Alp2 and AlpC, GBS-NN and GBS-NN2 in maternal and cord blood.
• To compare between groups the functional activity of vaccine specific antibodies from cord blood in an opsonophagocytic killing assay (OPkA) and other in vitro assays in selected samples.
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Kampala, Kawempe
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Uganda |
2021-06-08 |
2024-06-08 |
50 |
HIV negative and HIV positive pregnant women aged 18 to 40 years attending Kawempe national referral Hospital |
MINERVAX AS |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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