Wits RHI
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Zoliflodacin Trial
A multi-center, randomized, open-label, noninferiority Trial to evaluate the efficacy and safety of a Single, oral dose of zoliflodacin compared to a Combination of a single intramuscular dose of Ceftriaxone and a single oral dose of azithromycin in the Treatment of patients with uncomplicated gonorrhoea. Rationale There is growing concerns…
PrEP SMART
Evaluation of stepped PrEP adherence support for young South African women using a SMART design. Rationale To evaluate the proportion of young South African women who adhere well to PrEP with regular clinic visits and mHealth interventions alone, the proportion of women who adhere well to PrEP with intensified interventions…
TMC125-TiDP35
Continued access to etravirine in treatment experienced HIV-1 infected subjects. Rationale The aim of the study is to provide continuous access to ETR for subjects who have completed a clinical study with ETR sponsored by or in collaboration with Janssen Research & Development. Primary Objectives The primary objective is to…
INSIGHT Study
A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women. Study Objectives Estimate HIV incidence using the recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort. Assess the characteristics of women who…
IMPOWER – 022
A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection. Study Primary Objectives To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the prevention of HIV-1…
CoVPN 3008 Ubuntu Study
CoVPN 3008 Ubuntu Study: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Study Rationale The CoVPN 3008 Ubuntu study investigates the efficacy of the mRNA COVID-19 vaccine (mRNA-1273) among populations at increased risk of severe COVID-19, particularly individuals living with HIV (PLWH). This…
IAVI C100 Study
Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117- LS-J and 10-1074- LS-J, in Healthy American and African Adults (IAVI C100). Rationale Despite all efforts to increase access to HIV prevention and ART in South Africa, incidence of HIV infection continues to be unacceptably high with an estimated 220…
HVTN 805/HPTN 093
Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081. Rationale Antiretroviral therapy (ART) has greatly improved the health and quality of life for many people with HIV by suppressing…
HVTN 140/HPTN 101
A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in healthy, HIV uninfected adult participants. Rationale The HVTN 140/HPTN 101 study wants to understand how the body’s immune system responds to a new lab-made antibody against…
Crown Coronation
An international, Bayesian platform adaptive, randomized, placebo‐controlled trial assessing the effectiveness of candidate interventions in preventing COVID‐19 disease in adults. Primary Objectives To determine the effectiveness of MR (or MMR) vaccine in preventing symptomatic (i.e. any of the following: cough, shortness of breath or difficulty breathing, fever, chills, muscle pain,…
DAISY – Specific Aim 3
Delivery of Antiretrovirals via Implantable System for Young Children (DAISY) Specific Aim 3. Rationale South Africa reports one of the highest populations of HIV-infected young children and of the 55% of children that receive ART only 67% are virally suppressed. Adherence and retention in care are affected by multiple challenges…
IMPAACT 2010
Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants. Rationale To compare the virologic efficacy and safety of three antiretroviral regimens for HIV-1-infected pregnant women and to compare the safety of these regimens for their infants. Primary…
HPTN 084-01
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV among Adolescent Females – A Sub-study of HPTN 084. Rationale Despite reductions in other age groups, the number of deaths attributable to HIV is rising in the adolescent age group. As with many daily medication regimens,…
ChAdOx1 nCoV-19
An adaptive phase I/II randomized placebo-controlled trial to determine safety, immunogenicity and efficacy of non-replicating ChAdOx1 SARS-CoV-2 vaccine in South African adults living without HIV; and safety and immunogenicity in adults living with HIV. Rationale The COVID-19 pandemic has significantly disrupted healthcare systems and economies worldwide. Despite efforts, the virus…
MESA-TB Gates MRI
MESA-TB Gates MRI : A Randomized, Placebo-Controlled, Observer-Blind, Phase 2 Study to Evaluate the Safety and Immunogenicity of the Investigational M72/AS01E Mycobacterium tuberculosis (Mtb) Vaccine in Virally Suppressed, Antiretroviral-Treated Participants with Human Immunodeficiency Virus (HIV). Rationale Previous phase 1 and 2 randomized controlled trials have demonstrated that the M72/AS01E vaccine is…
Jansen ENSEMBLE: VAC31518COV3001
A Randomized , Double -Blinded, Placebo-Controlled Phase 3 Study to assess the Efficacy and safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older. Rationale The development of a vaccine for Coronavirus disease -19 (COVID-19) will be critical for containing the current outbreak and…
2019nCoV-505
A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M™Adjuvant in People Living with HIV. Rationale Novavax, Inc. is developing recombinant vaccines adjuvanted with the saponin-based Matrix-M adjuvant for the prevention of disease caused by SARS-CoV-2.…
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Established in 1994, Wits RHI is part of the Faculty of Health Sciences and the largest research institute of the University of the Witwatersrand.
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