Current Projects

HPRU has undertaken numerous clinical trials over the past 15 years. The Unit currently has six established clinical research sites in the greater Durban area, which are approved by the Division of AIDS (DAIDS) and equipped to run large-scale clinical trials. The Unit was the only centre globally to test four out of five microbicide products in five Phase III and 3 Phase II/IIb advanced microbicides clinical trials. The excellent work produced by HPRU gave the National Institutes of Health (NIH) the confidence to award it one of the largest grants outside of the USA to undertake HIV prevention research.

Key Clinical Trials
1 MTN 020: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women
2 MTN 003: Phase IIB Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/ Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV infection in Women
3 HPTN 035: Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel for the Prevention of HIV Infection in Women
4 CONRAD: Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission (Phase III)
5 Phase III Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women
6 MIRA (Phase III) : Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
7 MDP 301 PHASE III: An international multi-centre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 0.5% and 2% PRO 2000/5 gels for the prevention of vaginally acquired HIV infection

Current

PHASE II AND III CLINICAL TRIALS
2016
MTN 025: A Phase 3b Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women (HOPE)
2018
HVTN 703/ HPTN 081:  A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection
2018
HPTN 084A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
2017
HVTN 702: A pivotal phase 2b/3 multi-site, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in preventing HIV-1 infection in adults in South Africa
2018
HVTN 705: A multicenter, randomized, double-blind, placebo controlled phase 2b efficacy study of a heterologous prime/boost vaccine regimen of Ad26.Mos4.HIV and aluminum phosphate adjuvanted Clade C gp140 in preventing HIV-1 infection in women in sub-Saharan Africa
PHASE I CLINICAL TRIAL
2015
HVTN 100: A phase 1-2 randomized, double-blind, placebo-controlled clinical trial of clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59® in HIV-uninfected adults at low risk of HIV infection.
2015
HVTN 111: A phase 1 clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA and of MF59-adjuvant clade C Env protein, in heathy, HIV-uninfected adult participants.
2017
HVTN108: A phase 1/2a clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA, and of MF59®- or AS01B-adjuvanted clade C Env protein in various combinations, in healthy, HIV-uninfected adult participants
BIOLOGICAL TRIALS
2018
HVTN 702 Mucosal sampling sub-study: Mucosal systems in vaccine responses and HIV infection risk in a subset of participants enrolled in HVTN 702 sub-study
OBSERVATIONAL STUDIES
2009
MTN 015: An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials
2010
MTN 016: Evaluation of Maternal and Baby Outcome Registry after Chemoprophylactic Exposure (EMBRACE)
2018
HVTN 910: A protocol to assess the persistence of HIV vaccine-induced seropositivity in participants who received vaccine in DAIDS-funded preventive HIV vaccine trials
SOCIO-BEHAVIOURAL TRIALS
2012
MTN 020: Qualitative Study (component of MTN 020)
2016
MTN 032: To explore socio-contextual and trial specific issues, which affected ASPIRE and HOPE trials’ participants' adherence to the dapivirine vaginal ring (VR)
2016
Hotspots: To describe in detail, the social economic, behavioural context of women residing within HIV ‘hot spot’ areas compared to women residing in HIV ‘cold spots’
2017
HIP Study: Understanding social and motivational factors of participating in HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa
2018
Registration Cohort: Development of an HIV-negative registration cohort for future participation in an HIV vaccine study
2016
ALIGHT Botswana: Increasing participation of women and girls with disabilities in gender-based violence prevention programs in Botswana
2007
PEER study: Implementation and Evaluation of a Peer Education Programme in Communities
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