In an effort to find other options as HIV pre-exposure prophylaxis (PrEP), the National Institutes of Health launched a clinical trial to test the long-acting form of cabotegravir, an experimental anti-HIV drug.
Currently, the only approved PrEP regimen is Truvada, which consists of two anti-HIV drugs tenofovir disoproxil fumarate and emtricitabine. As Truvada is taken orally daily as a tablet, it may present a challenge to at-risk individuals looking for more discreet ways to prevent HIV, which the injectable cabotegravir is hoping to address.
"We urgently need more HIV prevention tools that fit easily into people's lives," said Anthony S. Fauci, M.D., NIH's National Institute of Allergy and Infectious Diseases (NIAID) director.
NIH HIV Prevention Clinical Trial
Called HPTN 083, the Phase 3 clinical trial will assess if the cabotegravir administered once every eight weeks via injection can effectively protect men, as well as transgender women, from HIV at least as well as Truvada.
NIAID is sponsoring the trial in collaboration with Gilead Sciences, ViiV Healthcare and the HIV Prevention Trials Network. Gilead Sciences and Viiv Healthcare will be providing medications for the trial.
HPTN 083 will have 4,500 participants across 45 trial sites in the United States, Vietnam, Thailand, South Africa, Peru, India, Brazil and Argentina. All participants are at high risk of acquiring HIV infections and will be aged at least 18 years old.
The large-scale clinical trial began on Dec. 20 and results are expected to be released in 2021.
Aside from medication, HPTN 083 participants will be provided with counseling, lubricant and condoms to prevent HIV. Routine checks for sexually transmitted infections will be done throughout the course of the study. If a participant tests positive for an STI, the individual will be given appropriate treatment. Those who contract HIV will be excluded from the trial and referred to local health care providers to receive appropriate care and treatment.
Cabotegravir For Women
A related study known as HPTN 084 will specifically test the efficacy and safety of cabotegravir as an injection for preventing HIV in women. This study is set to launch in 2017 and will be carried out in sub-Saharan Africa.
U.S. Response To HIV/AIDS
The U.S. President's Emergency Plan for AIDS Relief is the American government's initiative to aid in saving the lives of those living with HIV/AIDS around the globe. It's the largest commitment by any country to address a single disease internationally but it is driven by a responsibility shared among partner and donor nations and others who invest in saving lives.
Currently, there are 36.7 million people in the world living with HIV/AIDS.