HIV Treatment

March 2022 – February 2023

Treatment of HIV has been a core business of the Desmond Tutu Health Foundation since 1998. Two sites remain focused on HIV-treatment: the Groote Schuur Clinical Trials Unit (known as “J52”) and the Centre for Adherence and Therapeutics, adjacent to the Gugulethu Community Health Centre.

  • The Groote Schuur Clinical Trials Unit (J52) comprises a multidisciplinary team of 44 people, including doctors, nurses, pharmacists as well as lab, data and counselling staff. They manage a dedicated, state-of-the-art clinical trials unit with outpatient and inpatient pharmacokinetic facilities, with access to tertiary services of the world-famous Groote Schuur Hospital. Professor Robin Wood was the first to offer antiretroviral therapy to public sector patients through clinical drug trials at this site, when treatment was unaffordable and unavailable in sub-Saharan Africa.
  • The DTHF Centre for Adherence and Therapeutics (DCAT) is a smaller dedicated treatment unit with a focus on novel methods to measure and improve adherence to antiretroviral therapy, based in the Gugulethu community. Profs Linda-Gail Bekker and Catherine Orrell were the first to offer community-based ART at this site, in September 2002.

DTHF remains at the current edge of ART research, exploring new drugs, new formulations and new treatment strategies.

Treatment strategy studies include the D2EFT study (Dolutegravir and Darunavir Evaluation in adults Failing Therapy) which has recently presented week 48 results, showing that dolutegravir-based second-line options are as good to use as the current protease inhibitor-based options. This study has contributed to the data resulting in a change to the South African treatment guidelines.

During the COVID-19 epidemic the J52 team created the now decommissioned COVID Venue or The CoVe; temporary buildings erected in the car park of Groote Schuur Hospital, which allowed us to manage a number of COVID-19 treatment and prevention studies during 2020 and 2021. One of the treatment studies completed there was the AGILE study, in collaboration with the Universities of Southampton and Liverpool, an early phase (Ib and IIa) study to test the benefit of nitazoxanide in people with mild COVID-19 disease.

DCAT has been a critical site for learning about the newly registered injectable ART, intra-muscular cabotegravir (CAB) and rilpivirine (RPV). Injectable formulations are a breakthrough in HIV treatment, where viral suppression rates are reduced due to people being unable to manage the burden of daily tablet taking. FLAIR and ATLAS/ATLAS 2M are the original pharma studies which showed these injectables could maintain viral suppression in people whose viral load was already suppressed on oral medication. In addition to these studies, the DCAT teams are using two investigator-driven studies to explore the use of injectable preparation in more vulnerable populations:

IMPALA (IMProving HIV-1 Control in Africa with Long Acting Antiretrovirals): including those with documented poor adherence (figure 1, above)

AFINAty (Acceptability and Feasibility of long-acting INjectable ART in Adolescents and Young Adults): including adolescents and young people ages 12-24 (figure 2, below)

DCAT also explores, through a number of investigator-driven studies, the use of novel methods of measuring adherence: such as the Wisepill device and the Urine Tenofovir Rapid Test (UTRA). These studies are currently funded by the EDCTP (through Senior Fellowships) and the NIH (R01 and R21 mechanisms).

Another cluster of studies (MSD 017 and 020) explore the use of Islatravir, a new class of ART with the potential to be offered as a once a week or even once a month tablet. Islatravir is currently offered as a single daily tablet in combination with Doravirine, a newer non-nucleoside reverse transcriptase inhibitor. Due to a recent pause due to drug accumulation in CD4 cells, all patients have been switched onto a new lower dose. As a result, we have started investigating a similar drug, MK8427 which in early PK trials is showing promise for a long acting formulation (MK004).

Our inpatient ward has been used for a number of pharmacokinetic and early phase studies, including overnight stays for the DoRIS study (Drug Interactions between Dolutegravir and escalating-doses of Rifampicin Study) – creating PK profiles of dolutegravir with increasing doses of rifampicin – critical for maximising the use of this first-line anti tuberculosis agent. MSD004 (A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants) is a phase I study evaluating a new drug in small cohorts to explore the minimum dose for early viral suppression in ART-naïve individuals.

The DCAT and J52 team also cares for many participants whose regimens, after the study is completed, have not yet been made available in the public sector – at the Friday Compassionate Clinic. Participants there remain on some older drugs, including fosamprenavir, elvitegravir and maraviroc.

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