The National Institutes of Health said today that it has launched the first large-scale clinical trial of a long-acting injectable drug for HIV preparation in sexually-active women. The NIH is funding the study in partnership with ViiV Healthcare and the Bill & Melinda Gates Foundation.
The study, which is being conducted in southern and eastern Africa, is designed to test the safety and efficacy of an investigational anti-HIV drug, cabotegravir, injected once every eight weeks.
The current standard for HIV pre-exposure prophylaxis is Truvada, which is administered daily as an oral pill. Among adults in southern and eastern Africa, women accounted for 58% of new HIV infections last year, according to the NIH.
“This new study, driven by African women scientists and volunteers, is testing the efficacy of a new HIV prevention tool for women who need more options for protection,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in prepared remarks. “Taking a daily pill can be challenging for some people. For some women, a long-acting injectable form of protection may be an easier, more desirable and discreet alternative.”
“Injectable cabotegravir has the potential to give sexually active women a choice of biomedical HIV prevention tools for the first time—somewhat similar to the choices available to women for contraception,” protocol chair Sinead Delany-Moretlwe added. “Current HIV prevention tools can be especially difficult for women to control or negotiate with a partner. An effective, long-acting injectable drug would allow a woman to discreetly protect herself from HIV during sex.”
Viiv Healthcare and Gilead Sciences (NSDQ:GILD) are providing the medications for the 3,200-patient trial. During the 3.6 year-long study, researchers plan to randomize patients to either receive cabotegravir or Truvada. In the first five weeks, participants will receive two daily oral tablets – either cabotegravir, Truvada or a placebo. Then starting in the sixth week, participants in the cabotegravir group will receive injections of the drug and placebo tablets, while people in the control group will receive placebo injections and Truvada tablets.
Participants in the study will also receive HIV prevention counseling, as well as condoms and support to encourage adherence to the daily pill regimen. The group expects results from the trial to be available in 2022.
“HPTN 084 also will examine how women experience long-acting injectable cabotegravir — whether they find it desirable and usable,” protocol co-chair Dr. Mina Hosseinipour explained. “Understanding what types of HIV prevention fit best in women’s lives will help further refine HIV prevention research, delivering tools that are ultimately safe, effective and desired.”
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