About this study
Many people around the world are at risk of getting HIV (human immunodeficiency virus). Medicines called PrEP can help prevent HIV infection, but many people have trouble taking them every day or visiting a clinic often.
A medicine called lenacapavir may offer an easier option. Lenacapavir is an FDA-approved drug that blocks HIV from growing in the body. It may protect people from HIV with only 2 shots, given once a year. This could help more people stay protected and lower the number of new HIV infections.
This study will look at how lenacapavir works in the body when it is given as 2, once-a-year shots into a muscle. Researchers want to see how the drug moves through the body and how long it stays at a level that can help prevent HIV. They will also check if the shot causes side effects and is safe and how people feel after getting it.
People in the study will get 2 oral (by mouth) doses of lenacapavir and 2 injections on the first 2 days. After that, they will not need another injection for a year. Participants will visit the clinic several times during the year for checkups, blood tests, and counseling.
After the first year, they may choose to stay in the study and keep getting yearly injections until the medicine is available outside the study. Some people will join an extra part of the study to give more blood samples so researchers can learn more about how the drug works in the body.
This study will help researchers learn whether a yearly shot of lenacapavir is safe and strong enough to protect people from HIV. We also need to know if people prefer this option over daily pills. If it works well, this study could lead to a new, easier way to prevent HIV.
Eligibility overview
- Age 16 or older
- HIV negative
- At risk for HIV from recent sexual activity. This includes having sex without a condom with someone whose HIV status is not known.