Long-Acting Oral Treatments for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).
The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.
The primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.
Who Is on the Research Team?
Gilead Study Director
Principal Investigator
Gilead Sciences
Are You a Good Fit for This Trial?
This trial is for adults with HIV-1 who have had undetectable virus levels and have been taking Biktarvy (B/F/TAF) daily for at least 6 months. Participants must be generally healthy, have a CD4 count of at least 200, and agree to use birth control if they could become pregnant.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares switching to new long-acting weekly oral HIV treatments (GS-3242 plus Lenacapavir) versus continuing the standard daily pill Biktarvy. The goal is to see if the new regimens work as well in keeping the virus suppressed over 24 weeks.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment Arm B), administered concomitantly for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.
Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment C), administered concomitantly for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.
Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
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