HIV Prevention Clinical Trial For Women Launched

The first large-scale clinical trial for HIV prevention in sexually active women called HPTN-084, has launched.

This phase three clinical study in Africa will examine whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every eight weeks, can safely protect women at risk for HIV infection.

Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), said "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."

The only drug regimen currently licensed for HIV pre-exposure prophylaxis, or PrEP, is the anti-HIV medication Truvada taken daily as an oral tablet.

Truvada consists of two anti-HIV drugs, emtricitabine and tenofovir disoproxil fumarate.

Women accounted for 58 percent of new HIV infections among adults in southern and eastern Africa in 2016.

"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," said Sinead Delany-Moretlwe, M.B.B.Ch., Ph.D., the HPTN 084 protocol chair.

"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," said Dr. Delany-Moretlwe is associate professor and director of research at the Wits Reproductive Health and HIV Institute at the University of the Witwatersrand in Johannesburg.

This trial will enroll approximately 3,200 sexually active women aged 18 to 45 years at 20 sites in seven countries in southern and eastern Africa. The women are randomly assigned to either the cabotegravir group or the Truvada group. Neither the participants nor the study team will know who is in which group until the end of the trial.

The new trial complements HPTN 083, an ongoing NIH study launched in 2016 of long-acting injectable cabotegravir for HIV prevention in men who have sex with men and transgender women who have sex with men.

The U.S. National Institutes of Health (NIH) is sponsoring the trial, and the NIH-funded HIV Prevention Trials Network (HPTN) is conducting the study. ViiV Healthcare and Gilead Sciences Inc. are providing the study medications.

For more information about HPTN 084, please see Questions and Answers: The HPTN 084 HIV Prevention Study and study identifier NCT03164564.