A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination with Lenacapavir in Virologically Suppressed People With HIV. Objective: The objective of this multi-site study is to evaluate the safety and antiviral effect of an oral weekly regimen of islatravir in combination with lenacapavir.
Eligibility: To be eligible to participate in the study, individuals must be 18 years of older with a suppressed viral load on Biktarvy.
Description: Participants will be randomly allocated in a 2:1 ratio to receive oral weekly islatravir and lenacapavir or oral daily Biktarvy. Participants will receive study drugs for 48 weeks. Following completion of the Week 48 visit, participants on daily oral Biktarvy will be given the option to change to the oral weekly regimen of islatravir and lenacapavir.
Study Sponsor: Gilead Sciences
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*Please note this Clinical Trial and Summary was started while Community Resource Initiative was still known as Community Research Initiative (CRI). This information is still relevant.Contact our Research Team