ClinicalTrials.gov ID: NCT07682961

Brief Summary 

Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

The purpose of this Phase 3, open-label, multicenter, randomized, active-controlled study to evaluate the effectiveness and safety of switching to twice-yearly
LEN + TAB + ZAB versus switching to CAB + RPV every 8 weeks 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). The Screening Period will enroll PWH ≥ 18 years of age who are virologically suppressed and on a stable oral antiretroviral (ARV) treatment regimen for at least 6 months prior to screening The screening will establish whether a potential participant has HIV proviral phenotypic susceptibility to both TAB and ZAB using the investigational protocol-defined assay.

Approximately 590 participants with HIV-1 susceptibility to TAB and ZAB who meet additional eligibility criteria will be enrolled in the Treatment Period. In this period,  participants will be randomized in a 1:1 ratio to Treatment Groups 1 and 2 for parallel assignment to treatment.

Group 1 will reiceve the Experimental treament, Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB). These participants will receive oral LEN 600 mg, subcutaneous (SC) LEN 927 mg, and intravenously (IV) infusions of TAB and ZAB on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. Every 26 weeks, participants will receive SC LEN and IV infusions of TAB and ZAB up to Week 92.

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).

Group 2 will recieve the Active Comparator, Cabotegravir (CAB) + Rilpivirine (RPV). These participants will discontinue their baseline oral antiretroviral therapy (ART) and will receive intramuscular (IM) CAB 600 mg + RPV 900 mg on Day 1, Week 4 and then every 8 weeks for up to 92 weeks.