HPRU has undertaken numerous clinical trials over the past 20 years. The Unit has five established clinical research sites (CRSs) in the greater Durban area, which are approved by the Division of AIDS (DAIDS) and equipped to run large-scale clinical trials. Currently, the HPRU is conducting HIV injectable and vaccine trials several observational and behavioural research at the CRSs,. All clinical research is conducted in partnership with stakeholders as part of the HPRU community engagement programme Historically, the HPRU was the only centre globally to test four out of five microbicide investigational products in five Phase III and 3 Phase II/IIb microbicide clinical trials. The excellent work produced by HPRU gave the National Institutes of Health (NIH) the confidence to award HPRU one of the largest grants, at three grant funding cycles, outside of the USA to undertake HIV prevention research.
Current
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PHASE II AND III CLINICAL TRIALS
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| 2020 |
STI_Zoli001 Study - 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
National Clinical Trial Number: pending
Principal Investigator(s): Dr Elizabeth Spooner (Botha’s Hill CRS), Dr Vimla Naicker (Tongaat CRS)
Sponsor: Global Antibiotic Research and Development Partnership (GARDP)
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| 2018 |
PrEPVacc - A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomization to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.
National Clinical Trial Number: N/A
Principal Investigator(s): Dr Nishanta Singh (Verulam CRS)
PrEPVacc is a new African-led, European-supported HIV prevention study running in East and Southern Africa from 2018 to 2023.
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| 2018 |
HVTN 703/HPTN 081 (AMP) -A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa
National Clinical Trial Number: NCT02568215
Principal Investigator(s): Dr Mammekwa Mirriam Mokgoro (Botha’s Hill CRS), Dr Logashvari Naidoo (Chatsworth CRS)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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| 2018 |
HPTN 084: (LIFE) - A 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
National Clinical Trial Number: NCT03164564
Principal Investigator(s): Dr Nishanta Singh (Verulam CRS), Dr Dishiki Jenny Kalonji (Isipingo CRS), Dr Mammekwa Mirriam Mokgoro (Botha’s Hill CRS)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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| 2018 |
HVTN 705: (Imbokodo) - 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
National Clinical Trial Number: NCT03060629
Principal Investigator(s): Dr Logashvari Naidoo (Chatsworth CRS), Dr Vimla Naicker (Tongaat CRS)
Sponsor: Janssen Vaccines & Prevention B.V.
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| 2017 |
HVTN 702: (Uhambo) - 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
National Clinical Trial Number: NCT02968849
Principal Investigator(s): Dr Nishanta Singh (Verulam CRS), Dr Dishiki Jenny Kalonji (Isipingo CRS)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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2016
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MTN 025: (HOPE): A Phase 3b Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
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PHASE I CLINICAL TRIAL
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| 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
National Clinical Trial Number: NCT02915016
Principal Investigator(s): Dr Vimla Naicker (Verulam CRS)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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2015
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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.
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2015
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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.
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BIOLOGICAL CLINICAL RESEARCH
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2018
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HVTN 702 Mucosal sampling sub-study:
Mucosal systems in vaccine responses and HIV infection risk in a subset of participants enrolled in HVTN 702
National Principal Investigator: Mrs Kubashni Woeber
Sponsor: SAMRC
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OBSERVATIONAL STUDIES
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| 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
National Clinical Trial Number: N/A
Principal Investigator: Mrs Kubashni Woeber
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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| 2010 |
MTN 016: (EMBRACE): Evaluation of Maternal and Baby Outcome Registry after Chemoprophylactic Exposure (EMBRACE)
National Clinical Trial Number: NCT01209754
Principal Investigator: Ms. Samantha Siva (Botha’s Hill, Isipingo, Verulam, Tongaat and Chatsworth CRS)
Network: Microbicide Trials Network (MTN)
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2009
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MTN 015: An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials
National Clinical Trial Number: NCT00514098
Principal Investigator: Mr. Zakir Gaffoor (Botha’s Hill, Isipingo, Verulam, Tongaat and Chatsworth CRS)
Network or Sponsor: Microbicide Trials Network (MTN)
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SOCIO-BEHAVIOURAL TRIALS
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| 2018 |
Registration Cohort: Development of an HIV-negative registration cohort for future participation in an HIV vaccine study
Principal Investigator(s): Ms. Samantha Siva (Phoenix CRS, Verulam CRS)
Sponsor: European Developing Country Clinical Trial Partnership (EDCTP)
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| 2017 |
SHIOP - A Study to investigate Sexual health, HIV and co-morbidity with non-communicable infections among Older Persons
Principal Investigator(s): Dr Makandwe Nyirenda (Botha’s Hill CRS and Chatsworth CRS)
Sponsor: SAMRC
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| 2016 |
MTN 032: (AHA): Assessment of ASPIRE and HOPE Adherence
National Clinical Trial Number: NCT02702895
Principal Investigator: Ms. Neetha Morar (Botha’s Hill CRS)
Network: Microbicide Trials Network (MTN)
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| 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’ Principal Investigator: Prof Gita Ramjee Sponsor: SAMRC
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2012
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MTN 020: Qualitative Study (component of MTN 020)
Site Investigator: Mrs Kubashni Woeber (Isipingo CRS)
Network: Microbicide Trials Network (MTN)
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2007
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PEER study: Implementation and Evaluation of a Peer Education Programme in Communities
Principal Investigator: Ms. Neetha Morar
Sponsor: SAMRC and Trial sponsors
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| Historical completed - 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 |
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