A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States

Clinical Trial Details

The purpose of this study is to advance HIV prevention research for women in the United States, explore whether cisgender women prefer getting injections of Lenacapavir (LEN) or taking Truvada (F/TDF) pills.

Participants will be randomized into one of two groups. Randomized means the study treatment will be chosen by chance—like flipping a coin.

Group 1 will receive LEN injection on Day 1 and Week 26. Participants in this group will also receive 4 tablets of a loading dose of LEN to take on Days 1 and 2 (two tablets each day).

Group 2 will take Truvada (F/TDF) given as one tablet once daily from Day 1 onwards.

Participants will also get blood work done at study visits. Total study participation is expected to last about 2.5 years.

Key Eligibility:

18 years of age or older
Woman (assigned female at birth)
Have been sexually active with a man (condomless) in the last 12 months
Do not have HIV
Not pregnant or breastfeeding
Have not used long-acting PrEP in the past

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Chelsea - Manhattan

Contact(s)

Chelsea Clinic
(212) 746-7204

Protocol ID(s)

Weill Cornell Medicine IRB #:

2303025816

ClinicalTrials.gov:

NCT06101329

Status

Open to Enrollment

Age Group

Adult

Disease

HIV/AIDS and Infectious Diseases