The National Institute of Allergy and Infectious Diseases (NIAID) in the US has initiated the Phase III HPTN 083 trial of cabotegravir and truvada to treat men and transgender women with HIV.
Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir.
Truvada is a nucleoside analog reverse transcriptase inhibitor (NRTI) used in conjunction with other anti-HIV medicines to treat HIV-1 infection.
It consists of the two anti-HIV drugs emtricitabine and tenofovir disoproxil fumarate.
Sponsored by National Institutes of Health (NIH), NIAID is collaborating with ViiV Healthcare, Gilead Sciences and the NIH-funded HIV Prevention Trials Network (HPTN) to conduct the large-scale HPTN 083 clinical trial.
The study intends to determine the efficacy of the anti-HIV drug cabotegravir, injected once every eight weeks, in treating HIV infection or if it can be used in combination with daily oral anti-HIV medications such as truvada.
NIAID director Anthony Fauci said: “We urgently need more HIV prevention tools that fit easily into people’s lives.
“Although daily oral Truvada clearly works for HIV prevention, taking a daily pill while feeling healthy can be difficult for some people. If proven effective, injectable cabotegravir has the potential to become an acceptable, discreet and convenient alternative for HIV prevention.”
The trial is expected to enrol 4,500 men who are physically intimate with men and transgender women with men.
Participants will be aged 18 years or older and at high risk for HIV infection.
The participants will be randomly treated with two daily oral cabotegravir or truvada, and a placebo pill during the first five weeks.
In the sixth week, the participants receiving cabotegravir will receive injections of cabotegravir and oral placebo tablets on a daily basis, while participants receiving truvada will receive daily placebo injections and oral truvada tablets.
Results of this study are expected to be released in 2021.
Image: HIV particles on the surface of an infected macrophage. Photo: courtesy of Reconfirming the Traditional Model of HIV Particle Assembly.