Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens

This is a Phase 3, open-label, multicenter, randomized, active-controlled noninferiority study to evaluate the efficacy and safety of switching to twice-yearly Lenicapavir (LEN) + Teropavimab (TAB) + Zinlirvimab (ZAB) versus continuing stable baseline regimen (SBR) in virologically suppressed PWH that have virus susceptibility to TAB and ZAB and who are receiving treatment with an oral daily regimen. The study will consist of 2 periods: a broadly neutralizing antibody (bNAb) Susceptibility Screening Period (3a) and a Treatment Period (3b). Approximately 590 participants with HIV-1 susceptibility to TAB and ZAB by protocol-defined criteria who meet all eligibility criteria will be enrolled. In the Randomized Phase of the Treatment Period, participants will be randomized in a 1:1 ratio to Treatment Groups 1 and 2. Eligible participants who complete the randomized study treatment through at least Week 92 and the end of randomized treatment (ERT) visit will be offered the option to participate in the study Extension Phase (EXT).

Study GS-US-536-6544 is being conducted in parallel with Study GS-US-536-5938 with the aim
to pool data generated from these 2 studies for evaluating key program objectives.

Participant Eligibility

Inclusion Criteria: (At time of Screening)
1. At least 18 years old or older and currently living with HIV.
2. Currently on stable oral antiretroviral therapy (ART) for at least 6 months or more.
3. Recent changes in ART are 3 months or more prior to screening.
4. Current HIV VL is undetectable with supporting lab data.

Exclusion Criteria: (At time of Screening)
1. Less than 18 years old.
2. History of stage 3 HIV opportunistic infections.
3. Active, serious infections.
4. Active tuberculosis infections.
5. Acute hepatitis of any cause less than 30 days prior to randomization.
6. History or current clinical depompensated liver cirrhosis: (ascites, encephalopathy)
7. Active cancer or malignancy requiring acute systemic therapy.
8. Currenlty pregnant or breast feeding.

Contact

Clay Youngblood, RN
(206) 773-7129