drugset / Trial / NCT06513312

Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)

NCT06513312

Phase 2 Active not recruiting 268 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelPrevention

Summary

The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP). The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.

Timeline

Start
2024-10-07
Primary completion
2026-05-28
Completion
2028-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Emtricitabine/tenofovir disoproxil fumarate Unknown Oral
Subject Lenacapavir Small molecule 927 mg Subcutaneous

Indications

No indication recorded.