Clinical Trials - HIV/Aids - Completed Studies

Completed HIV/Aids studies

Our completed clinical trials in HIV/Aids are listed here:

NCT00036452

Protocol number title: Comparison of twice daily ART vs once daily ART and Self-Administered ART vs. DOT ART.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne Interventional Closed 2005/2006 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)/ Other

NCT00055120

Protocol number title: ART for HIV-Infected Adults with Acute OIs: Immediate vs. Deferred Initiation.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne Interventional Closed 2005/2006
    AIDS Clinical Trials Group (ACTG)
National Institutes of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID)

NCT00084136

Protocol number title: Once-Daily PI + Non-NRTI Regimens for Initial Treatment in Resource-Limited Settings.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne/Dr Firnhaber Interventional Closed 2005/2010 AIDS Clinical Trials Group (ACTG) AIDS Clinical Trials Group/National Institute of Allergy and Infectious Diseases (NIAID)/NIH

NCT00100867

Protocol number title: Safety/Toxicity of Infants of HIV-Infected Women in ART Protocols .

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Firnhaber/Dr Badal-Faesen Observational Closed 2006/2010 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)/Other

NCT00096824

Protocol number title: International Neurological Study.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne Observational Closed 2005/2010 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)/Other

NCT00099632

Protocol number title: 3 ART Strategies to Reduce NVP-Resistant HIV After Intrapartum Single Dose Nevirapine.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Conradie Interventional Closed 2006/2010 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)

NCT00089505

Protocol number title: Optimal Combination Therapy After Nevirapine Exposure.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne/Dr Conradie Interventional Closed 2005/2011 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)

NCT00885703

Protocol number title: High-dose Fluconazole for pre-ART CM Patients.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne/Dr Ive Interventional Closed 2011/2013 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)

NCT00357552

Protocol number title: Study of LPV/r in Subjects with Virologic Relapse on NNRTI-Containing Regimens.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Badal-Faesen Interventional Closed 2007/2012 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)

NCT00608569

Protocol number title: Modified Directly Observed Therapy vs. Self-Administered Therapy for First Virologic Failure on Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI).

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Rassool Interventional Closed 2008/2011 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)

NCT01352715

Protocol number title: Study of Options for Second-Line Effective Combination Therapy (SELECT).

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Rassool Interventional Closed 2012/October 2014 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)

NCT00102960

Protocol number title: Study of Antiretrovirals treatment strategy in resource-poor settings

This study found that nurses are not inferior to doctors in the monitoring of ART. It demonstrated the effectiveness of task-shifting treatment from doctors to nurses and was widely quoted in both international and the World Health Organisation’s ART guidelines. It also led to the expansion of ART to primary health care settings in SA and internationally. This study has been followed by health economic evaluations and national costing models of ART.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne/Dr Conradie Interventional Closed 2009/2010 National Institutes of Health (NIH) National Institutes of Health (NIH)

NCT 00100646

Protocol number title: Randomised trial of limited interruptions of PI-based ARV therapy VS Continuous therapy of HIV-1 infection (2005-2009)

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne/Dr Firnhaber Interventional Closed 2005/2009 Wistar Institute National Institutes of Health (NIH)

NCT00074581

Protocol number title: HIV Treatment as Prevention Antiretroviral Therapy Study – Phase III, two-arm, randomized, controlled, multi-centre trial to determine whether antiretroviral therapy (ART) can prevent the sexual transmission of HIV-1 in HIV-1 serodiscordant couples.

SA was one of nine countries participating in this study which was a landmark study proving that early ART can prevent HIV transmission. The findings demonstrate that ART, when taken until viral suppression is achieved and sustained, is a highly effective, durable intervention for HIV prevention. Following the interim results of this study, the World Health Organization recommended that ART be offered to all people living with HIV who have uninfected partners.

Principal Investigator (PI) Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Badal-Faesen Interventional Closed 2007/2015 HIV Prevention Trials Network (HPTN) National Institution of Health and Research

NCT00326716

Protocol number title: A pilot study of atazanavir (ATV)/Ritonavir (RTV) administered as part of highly active antiretroviral therapy (HAART) therapy in HIV-1 infected pregnant women.

This study explored the pharmacokinetics in pregnant women, safety in their neonates, efficacy and tolerability in pregnant women, and prevention of mother-to-child transmission of HIV.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial study Funders/ sponsors
Dr Conradie Interventional Closed 1998/2001 Bristol-Myers Squibb /GlaxoSmithKline (GSK)

NCT02131233                                                                        

Protocol number title: A Phase III multicentre, double-blind, randomized, active comparator-controlled clinical trial.

This trial aimed to evaluate the safety and efficacy of Raltegravir (MK-0518) 1200 mg once daily versus Raltegravir (MK-0518) 400 mg twice daily, each in combination with TRUVADA™, in treatment-naïve HIV-1 infected individuals.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial study Funders/ sponsors
Dr Rassool Interventional Closed AUG 2014/DEC 2016 MERCK/MSD

NCT01641367

Protocol number title: Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE).

This study assesses the use of a resistance test to choose anti-HIV drugs. It also aims to see:

  • how well combinations of new anti-HIV drugs work to lower HIV infection
  • if taking new anti-HIV drugs together is safe and tolerable and
  • if text messages improve adherence.

The study compares how these drugs act in people taking certain combinations of anti-HIV drugs with anti-TB drugs and evaluates how people do after they stop frequent clinic visits as part of a research study.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Badal-Faesen Interventional Closed 2013-2018 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)

NCT01241643

Protocol number title: A multicentre, open-labelled, controlled, randomized study of recombinant Interleukin-7 (CYT107) treatment to restore and maintain CD4 T-lymphocyte counts above 500 cells/µL in HIV-infected patients with CD4 counts remaining between 101-350 cells/µL after at least 2 years of HAART and plasma HIV RNA < 50 copies/mL for 18 months. (2010-2013).

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Ive Interventional Closed 28-09-2010 – 03-07-2013 Cytheris SA Cytheris Incorporation

NCT to follow

Protocol number title: A descriptive study of the genotypic resistance profiles of patients failing first- and second-line therapy in national rollout site in South Africa.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Investigator-driven study Funders/ sponsors
Dr MacPhail Observational Closed 1998 University of Witwatersrand, South Africa

NCT01601899

Protocol number title: Molecular, biochemical and clinical differences between Stavudine and Tenofovir, each combined with lamivudine and Efavirenz, in HIV-infected patient.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Investigator-driven study Funders/ sponsors
Dr Menezes Interventional Closed 2007/2011 University of Witwatersrand, South Africa

NCT01003990

Protocol number title: Atazanavir for HIV-infected individuals who are completing Atazanavr clinical trials, Rollover for AI421-03.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial study Funders/ sponsors
Dr Ive Interventional Closed Oct 2002/Feb 2016 Bristol-Myers Squibb

NCT00326716

Protocol number title: A Pilot Study of Atazanavir (ATV)/Ritonavir (RTV) Administered As Part Of HAART Therapy in HIV-1 Infected Pregnant Women: Exploring The Pharmacokinetics In Pregnant Women, Safety In their Neonates, Efficacy And Tolerability In Pregnant Women, And Prevention Of Mother-To-Child Transmission of HIV.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial study Funders/ sponsors
Dr Conradie Interventional Closed 1998/2001 Bristol-Myers Squibb

NCT00272779

Protocol number title: A 96 Week Phase IIIB Study Comparing The Antiviral Efficacy And Safety Of Atazanavir/Ritonavir (ATV/RTV) with Lopinavir/Ritonavir (LPV/RTV), Each In Combination With Fixed Dose Tenofovir-Emtricitabine-Emtricitabine.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial study Funders/ sponsors
Dr Firnhaber Interventional Closed 1998/2001 Bristol-Myers Squibb

NCT

Protocol number title: A Randomised. Double blinded equivalence trial study comparing emtricitabine to lamivudine within a triple combination in ART drug naïve HIV-1 infected patients.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial study Funders/ sponsors
Dr Sanne Interventional Closed 1998/2003 Triangle Pharmaceuticals/NIH AIDS Clinical Trials Information Service

NCT00017992

Protocol number title: Open label study of a once daily dose of emtricitabine in combination with other Antiretroviral agents in HIV-Infected Paediatric.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial study Funders/ sponsors
Dr Ndiweni/Dr Francesca Interventional Closed 1998/2003 Triangle Pharmaceuticals/NIH AIDS Clinical Trials Information Service

Protocol number title: Creating an International Network on HIV Drug Resistance in Africa

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Ive Observational Closed 2007/2011 Stichting Pharmaceutical Stichting Pharmaceutical

NCT00002362

Protocol number title: A randomised, open label study of emtricitabine combined with stavudine and emtricitabine versus abacavir combined with stavudine and emtricitabine in HIV infected patients who are treatment naïve. (1998- COMPASSIONATE).

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial Funders/ sponsors
Dr Sanne Interventional Compassionate 1998 – ongoing MERCK/MSD

NCT00098293

Protocol number title: A Multicentre, Randomized, Double Blind, Comparative Trial of a Novel CCR5 Antagonist, UK-427, 857, in Combination with Zidovudine / Lamivudine versus Efavirenz in Combination with Zidovudine / Lamivudine for the Treatment of Antiretroviral-Naïve HIV-1 Infected Subjects

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial Funders/ sponsors
Dr Ive Interventional Roll over June 2012/ June 2016 ViiV Healthcare/Pfizer

NCT02131233

Protocol number title: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Raltegravir (MK-0518) 1200 mg Once Daily Versus Raltegravir (MK-0518) 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects

PI Interventional / Observational Closed/ Ongoing Start/
end date
Commercial Funders/ sponsors
Dr Rassool Interventional Closed AUG 2014/DEC 2016 MERCK/ MSD