November 2, 2019
HIV continues to be a healthcare challenge in sub-Saharan Africa. HJF Medical Research International (a wholly-owned subsidiary of HJF), the Kenya Medical Research Institute and others are conducting research on HIV prevention options for HIV-uninfected women. It’s the first large-scale trial for this group of a long-acting injectable drug compared to a daily pill.
The HTPN 084 trial—also known as the Life (Long-Acting Injectable for the Epidemic) Study—is a Phase 3, multi-site, double-blind, two-arm randomized (1:1), controlled superiority trial of the safety and efficacy of Long Acting Injectable Cabotegravir (CAB LA) compared to daily oral TDF/FTC (Truvada) for Pre-Exposure Prophylaxis (PrEP) in HIV-uninfected women at high risk of acquiring HIV. The study in Kisumu is funded through the Emory-CDC Clinical Trials Unit (UM1A069418) through the HIV Prevention Trials Network of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases with joint funding from the Bill & Melinda Gates Foundation and ViiV Healthcare.
Taking a daily pill is an effective tool for preventing HIV, however, it is hypothesized that expanded choices for HIV prevention will similarly increase utilization, satisfaction, and effectiveness of global HIV prevention efforts. In addition, women deserve HIV prevention options that are safe, effective, and they feel comfortable using.
The study, which began in late 2017, is scheduled to last approximately four and a half years. The goal is to enroll 3,200 women aged 18 to 45 years across 20 sites in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda, and Zimbabwe.
After randomization, the study progresses through three phases: a five-week oral run-in phase; an injection phase for up to 3.5 years; and a 48-week open label phase with daily oral Truvada to cover the pharmacokinetic tail for Cabotegravir. The study will be conducted on the background of the best available combination HIV prevention package, including behavioral risk reduction, diagnosis and treatment of STIs, adherence counseling, and provision of condoms.
Results are expected in 2023. After the study is completed with positive results, the regulatory approval process has several steps, including review and approval by the U.S. Food and Drug Administration and other regulatory agencies.