Abstract
A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the World Health Organization for persons at high risk of acquiring HIV, but not all countries immediately adopted those recommendations. The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to SoC and PrEP in HIV prevention clinical trials taking place in lower- to middle-income countries (LMIC). Policymakers, regulators, ethicists, experts in law, researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. A group of subject matter experts presented on the regulatory, ethical, scientific, and historic framework of SoC in clinical trials, focusing on PrEP in South Africa. Summit participants discussed how and when to include new HIV treatment and prevention practices into existing clinical guidelines and trial protocols, as well as the opportunities for and challenges to scaling up interventions. The summit addressed challenges to PrEP provision, such as inconsistent efficacy amongst different populations and various biological, virological, and immunological explanations for this heterogeneity. Advocates and community members propagated the urgent need for accessible interventions that could avert HIV infection. The meeting recommended supporting access to PrEP in HIV prevention trials by (1) developing PrEP access plans for HIV vaccine trials, (2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism, and (3) supporting the safety monitoring of PrEP. This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials.
Highlights
HIV prevention has evolved tremendously over the last decade
Several randomized controlled trials (RCTs) comparing different combinations of oral tenofovir disoproxil fumarate (TDF) and TDF/emtricitabine (TDF/FTC, brand name Truvada) in serodiscordant couples have shown that pre-exposure prophylaxis (PrEP) can reduce HIV acquisition, to different extents based on the population [5–7]
The recommendations of the Ministry of Health, South African ethics boards, research teams, and the vulnerable communities should be heeded in clinical trials conducted in any lower- to middle-income countries (LMIC)
Summary
HIV prevention has evolved tremendously over the last decade. Traditionally, antiretroviral therapy (ART) was prescribed to people living with HIV (PLWH) to slow the progression of AIDS when CD4+ T-cell counts dipped below 200 cells per microliter. In a trial of serodiscordant couples that compared early ART administration (irrespective of CD4 counts) to delayed, the early treatment reduced the risk of sexual HIV transmission to their uninfected partner by over 90% [1, 2]. This study, conducted by the HIV Prevention Trials Network (HPTN) HPTN 052, has since been joined by other trials that have shown undetectable viral loads prevent transmission and solidified the use of ART for TasP [3, 4]. The ‘inverse’ of HPTN 052 was investigating the efficacy of ART when administered to the HIV-uninfected partner in a serodiscordant relationship, a concept of pre-exposure prophylaxis (PrEP). Several randomized controlled trials (RCTs) comparing different combinations of oral tenofovir disoproxil fumarate (TDF) and TDF/emtricitabine (TDF/FTC, brand name Truvada) in serodiscordant couples have shown that PrEP can reduce HIV acquisition, to different extents based on the population [5–7]. Prevention efficacy is robust in men, but contradictory results have been reported in women [5–9]
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