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First received: October 20, 2023

Clinical Trial: Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN-103)

Study Status: Completed

Recruit Status: RECRUITING

Condition: Pre-Exposure Prophylaxis of HIV Infection

Study Type: INTERVENTIONAL


Official Title: A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject

Brief Summary: The goals of this clinical study are to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF) for pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US).The primary objectives of this study are:To characterize the pharmacokinetics (PK) of LEN.To evaluate the safety of LEN and F/TDF for PrEP in US PWID.

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