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Background

GSH
The DTHF Clinical Trials Unit (CTU) is the oldest and most established of the clinical research sites of the Desmond Tutu HIV Foundation. The unit was originally founded by Professor Robin Wood and Sister Elizabeth Fielder in the 1990s as the HIV Research Unit in the New Somerset Hospital. This was the first clinic to offer antiretrovirals to public sector patients through clinical drug trials when treatment was unaffordable in sub-Saharan Africa.

In this pioneering spirit, the site was the only African site to take part in the SMART study and the pre-exposure prophylaxis iPrEx study, and is the regional coordinating site for the START study. As well as running investigator initiated trials, the CTU participates in antiretroviral pharmaceutical drug trials for GlaxoSmithKline, Merck Sharpe & Dohme, Bristol-Myers Squibb, ViiV healthcare and Gilead, amongst others.

Since the start of our trials unit at Somerset Hospital, we have managed over 60 pharmaceutical and investigator driven studies. Our focus is on HIV treatment trials, but we also have extensive experience in HIV prevention studies, vaccine studies and Phase I and II pharmacokinetic studies.

In 2013 the CTU partnered with the Faculty of Health Sciences, Departments of Medicine and Pharmacology at the University of Cape Town to establish an expanded trials unit in Groote Schuur Hospital which is comprised of consulting and counselling rooms, a dedicated pharmacy and laboratory and a 24 bed PK unit run by the division of Clinical Pharmacology.

Current Trials

Sponsor: Gilead Sciences, Inc.
DTHF PI: Assoc Prof Catherine Orrell
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GS–US-292-1515

A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed  Adolescents.

More Info: Click Here

Sponsor: Viiv Healthcare
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GSK-200304

A Phase 3b, randomised, open-label study of the antiviral activity and safety of dolutegravir compared to lopinavir/ritonavir both administered with dual nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected adult subjects with treatment failure on first line therapy

More Info: Click Here

Sponsor: Viiv Healthcare
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Recruiting

ING117175

A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir or efavirenz each administered with two NRTIs in HIV-1-infected antiretroviral therapy-naïve adults starting treatment for rifampicin-sensitive tuberculosis

More Info: Click Here

Sponsor: National Institute of Health
DTHF PI: Prof LG Bekker
Site: Groote Schuur CTU
Status: Active - Not Recruiting

The Sibanye Health Project

Comprehensive HIV prevention package for MSM in Southern Africa: Pilot Study

The objective of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioural and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South Africa.

Sponsor: HIV Prevention Trials Network
DTHF PI: Karen Dominguez
Site: Groote Schuur CTU
Status: Active - Not Recruiting

HVTN 075

Feasibility of HIV Prevention Cohort Studies among Men who have Sex with Men in Sub-Saharan Africa.

This study aims to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).

Sponsor: Merck Sharp & Dohme Corp
DTHF PI: Assoc Prof Catherine Orrell
Site: Groote Schuur CTU
Status: Active - Not Recruiting

MK-1439-018

A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA’ or EPZICOM /KIVEXA in Treatment-Naive HIV-1 Infected Subjects

More Info: Click Here

Sponsor: HVTN
DTHF PI: Prof Linda-Gail Bekker
Site: Groote Schuur CTU
Status: Active - Not Recruiting

HVTN CTAC

Establishing Immunologic Assays for Standardized Analyses of Clinical Specimens.

The aim of this study is to recruit individuals to provide blood, body fluids and mucosal specimens that will function as controls to standardize laboratory assays performed in HIV vaccine and other clinical trials.

Sponsor: Viiv Healthcare
DTHF PI: Assoc Prof Catherine Orrell
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GSK-ING-117172

A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women

More Info: Click Here

Sponsor: Bristol-Myers Squibb
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Active - Not Recruiting

BMS-AI438-011

A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-label Period on the Recommended Dose

More Info: Click Here

Sponsor: University of Minnesota and the INSIGHT Network
DTHF PI: Prof Robin Wood
Site: Groote Schuur CTU
Status: Active - Not Recruiting

START

Strategic Timing of Antiretroviral Treatment (START)

The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality in HIV-1 infected persons who are antiretroviral naïve with a CD4+ count above 500 cells/mm3.

More Info: Click Here

Sponsor: Gilead Sciences, Inc.
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GS-US-236-0112

A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women

More Info: Click Here

Sponsor: Gilead Sciences, Inc.
DTHF PI: Assoc Prof Catherine Orrell
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GS–US-292-0106

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents

More Info: Click Here

Sponsor: Microbicide Trials Network
DTHF PI: Prof Linda-Gail Bekker
Site: Groote Schuur CTU
Status: Completed

MTN-017

A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

More Info: Click Here

Sponsor: Merck Sharp & Dohme Corp
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Active - Not Recruiting

MK-0518-292

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

More Info: Click Here

People

The DTHF CTU is headed by Professor Robin Wood who is an infectious disease specialist and the principal investigator on the START study. Prof Linda-Gail Bekker oversees the prevention work at the DTHF and is principal investigator of the NIH UCT CTU. Other principal investigators in the CTU are Associate Professor Catherine Orrell and Dr Richard Kaplan. The unit is supported by a team of six sub-investigators: Doctors Piotr Chodacki, Keren Middelkoop, Francois Cilliers, Anna Cross, Yashna Singh and Precious Garnett.

Christie Heiberg is the dedicated manager of the CTU and Karen Dominguez manages the Key Populations Division  and is supported by a highly skilled team, trained in conducting HIV prevention research with hard to reach and high risk populations.

Treatment Trials

Robin Wood
Robin Wood

Unit Head

Catherine Orrell
Catherine Orrell

Principal Investigator

Richard Kaplan
Richard Kaplan

Principal Investigator

Christie Heiberg

Unit Manager

Maureen Rattley
Maureen Rattley

Study Coordinator

Anna Witbooi

Research Nurse

Anna Cross

Sub-investigator

Keren Middelkoop

Sub-investigator

Monica Vogt

Laboratory Coordinator

Nomvuselelo Kalolo

Therapeutic Counselor

Phyllisity Smith

Senior Research Nurse

Prevention and MSM Trials

Linda-Gail Bekker

Principal Investigator

Daniel Ndzuzo

Research Assistant

Piotr Chodacki

Sub-investigator

Karen Dominguez

Key Populations Project Manager

Lindsay Gcwabe

Research Assistant

Nehemiah Advance

Research Assistant

Siyabonga Mdlalo

Outreach Worker

Xolani Mvula

Senior Outreach Worker

Brian Kanyemba

Research Assistant

Facilites

  • A large patient waiting area
  • Four clinical examination rooms and one phlebotomy / specimen room (blood room)
  • Procedures room for Electrocardiograms (ECG) and spirometry
  • A fully equipped pharmacy with a separate counselling office, for dispensing and education purposes
  • A fully equipped laboratory with primary and secondary continuous temperature monitoring for fridges and freezers
  • Five counselling rooms, one of which is a dedicated room for HIV Counselling and Testing (HCT)
  • Two large study administration offices
  • Secure patient record storage in lockable high density storage units in the reception area
  • A fully equipped emergency trolley and staff trained in the use of resuscitation equipment
  • 12-lead ECGs with data transfer capabilities
  • Five automated, calibrated vital sign monitors (including oxygen saturation)
  • A calibrated electronic scale and stadiometer
  • Telephones, fax machines, photocopiers, scanners and computers with internet access.
  • Within the larger UCT Clinical Research Centre (CRC) is an echocardiogram room, office space for the data manager and regulatory officer and a meeting room.
  • The Division of Pharmacology’s 24 bed pharmacokinetic unit (PK Unit) is also within the CRC.

Recruitment

The DTHF CTU has achieved the highest enrolment figures for five international studies, including the START study, Second Line, Encore, TMC12-C238 and Pfizer A5271022. Our main source of referrals is from large primary care antiretroviral clinics that we have helped to establish over the last decade.

The unit has a dedicated team of counsellors and community-based recruiters who are responsible for inviting participants to enroll in prevention or treatment studies. They also assist with retention by providing adherence counselling, conducting home visits for patients enrolled in studies and tracking participants who have missed appointments. Their work has resulted in the high adherence rates and extremely low rates of loss to treatment observed in our clinical trials.

Investigator driven clinical trials

Year Trial Enrolment Retention**
2009 START* 287 99%
2009 iPrEx 88 89%
2010 Second-Line 50 100%
2011 Encore 1 62 100%
2014 MTN017* 16 100%

Pharmaceutical studies

Year Trial Enrolment Retention**
2008 VIR201-04-06 47 91%
2008 BI1100. 1486 20 100%
2008 TMC114-C229 6 83%
2008 TMC278-C209 4 100%
2008 PO4875 11 100%
2009 A527-1015 17 100%
2010 AI5271022 9 100%
2010 TMC125-C238 6 100%
2011 AI438011* 18 89%
2012 AI467003 23 100%
2014 GS-US-292-0106* 1 100%
2014 GS-US-236-0112* 3 100%
2014 ING117172* 43 98%
2014 MSD518-292* 27 100%

* studies ongoing
**Losses=Pregnancy, withdrawal of consent or LTFU. Excludes transfer-out and withdrawal due to AE or study end point.

Contact

Trials Unit Manager – Christie Heiberg
Email: Trials@hiv-research.org.za
Telephone: (+27) 21 650 6964
Facsimile: (+27) 21 447 1025

Physical address
Desmond Tutu HIV Foundation
J52 Old Main Building
Groot Schuur Hospital
Main Road, Observatory, Cape Town 7925

Postal address
Desmond Tutu HIV Foundation
P O Box 13801
Mowbray 7705