drugset
drugset / Trial / NCT06101329

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

NCT06101329 ↗

Phase 2 Active not recruiting 253 enrolled Gilead Sciences HIV Prevention Trials Network · collab
RandomizedParallel-groupOpen-labelPrevention

Summary

The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US. The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.

Timeline

Start
2023-11-17
Primary completion
2026-07
Completion
2028-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Emtricitabine/Tenofovir Disoproxil Fumarate Unknown 200 mg Oral
Subject Emtricitabine/Tenofovir Disoproxil Fumarate Unknown 300 mg Oral
Subject Lenacapavir Small molecule 600 mg Oral
Subject Lenacapavir Small molecule 927 mg Oral

Indications

No indication recorded.