A clinical trial to test a new, potentially more convenient HIV prophylaxis for women is starting in Africa. It is a long-acting form of the investigational drug cabotegravir and could give sexually active women a choice of biomedical HIV prevention tools for the first time, similar to the choices available for contraception, says Sinead Delany-Moretiwe, PhD, chair of the protocol.
The trial, HPTN 084, will enroll about 3,200 women aged 18 to 45 years at 20 sites in 7 countries. The women will be randomly assigned to either cabotegravir and a placebo pill or Truvada, which is a combination of emtricitabine and tenofovir disoproxil fumarate. Truvada, currently the only drug licensed for HIV pre-exposure prophylaxis, must be taken every day to achieve and maintain protective drug concentrations. The women will start with 2 cabotegravir injections 4 weeks apart, then receive injections once every 8 weeks for an average of 2.6 years. After completing the injections, participants will be offered 48 weeks of PrEP with daily oral Truvada.
The NIAID is sponsoring the phase 3 clinical trial and cofunding it in a unique partnership with ViiV Healthcare (which is providing the study medications with Gilead Sciences) and the Bill & Melinda Gates Foundation.
Participants will receive HIV prevention counseling, condoms and lubricant, and counseling to support adherence to the daily pill. Anyone who becomes HIV infected during the trial will stop receiving the study products and be referred to local medical providers for care and treatment.
The study also will evaluate how women experience long-acting injectable cabotegravir, the researchers say. They are hoping to get a better understanding of the types of safe and effective HIV prevention that also fit best in women’s lives.