Clinical Trials Unit
The Clinical Trials Unit at the DTHC headquarters at the University of Cape Town, has conducted a wide diversity of trials since its establishment in 1993. The majority of the patients attending the unit are on treatment pharmaceutical trials with all drug monitoring and clinical expenses covered by the companies concerned. Some patients who are post trial receive support for their continued treatment from the Pepfar funded Compassionate Use Programme. Innovative trials and studies are in progress concerning investigational products and/or strategies for the treatment and/or prevention of HIV. Partnership with local and provincial HIV and ARV clinics has contributed substantially to their success.
We have included three investigator driven studies to our portfolio which has strengthened our academic interests. The trials unit currently has 280 patients on studies and in the compassionate programme.
• Investigating the safety and efficacy of a therapeutic vaccine for HIV participants. It is hoped that the vaccine will enhance existing, or generate new, anti-HIV immune responses in those already infected with HIV. In addition the clinical trials unit is the only site in South Africa where the PK sub-study is being undertaken.
• The unit has been selected to participate in a leading multi-centred treatment strategy funded by the NIH: START (Strategic Timing of Antiretroviral Treatment). The study has commenced and our site is the highest recruiting site in the world.
• The unit is also participating in two international investigator driven studies sponsored by the University of New South Wales. These studies will answer important questions about HIV treatment and we have exceeded our enrolment targets.
• The PrEP Study has proved the efficacy and safety of pre-exposure prophylaxis in a high risk HIV negative male patient population of men who have sex with men (MSM). The study has revolutionised the recruitment and retention strategies of the clinical trials unit.
Projectleaders: Dr Catherine Orrell and Christie Heiberg