Phase 1 Study of Long-Acting Cabotegravir Injection to Prevent HIV and Explore Hormone Interactions in Adults 19 and Older

What this Trial Is About

Researchers are evaluating how long-acting cabotegravir CAB-LA works to prevent HIV in adults aged 19 years or older. This phase 1, open-label study also examines how natural and therapeutic hormones affect the drugs behavior in the body. The study focuses on measuring drug levels directly in blood, rectal and genital tissues, and secretions to better understand CAB-LAs pharmacology, especially at sites where HIV transmission occurs. Participants will receive a single 600 mg intramuscular injection of CAB-LA using the FDA-approved method. The study includes three groups males not using hormones, males on hormone therapy, and females using non-hormonal contraception. Over about 12 weeks, participants will have multiple visits for biopsies, blood draws, and fluid collections to measure CAB-LA concentrations and hormone levels, as well as to assess tissue susceptibility to HIV before and after drug exposure. Participants will undergo screening and a baseline visit with evaluations including HIV tests and hormone measurements. During the study, they will attend several visits for biopsies, blood tests, and safety monitoring, including medication logs to track hormone use. Researchers will measure plasma and tissue drug levels, hormone concentrations, and HIV tissue response over 12 weeks. The study aims to understand drug interactions and safety while participants receive the injectable medication and complete all scheduled assessments.

Cabotegravir-Hormone PK/PD Interactions for HIV Prevention