drugset / Trial / NCT07682961

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

NCT07682961

Phase 3 Not yet recruiting 590 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.

Timeline

Start
2026-07
Primary completion
2029-03
Completion
2033-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cabotegravir Small molecule 600 mg Intramuscular
Subject Lenacapavir Small molecule 600 mg Subcutaneous
Subject Lenacapavir Small molecule 927 mg Subcutaneous
Comparator Rilpivirine Small molecule 900 mg Intramuscular
Subject Teropavimab Monoclonal antibody Intravenous
Subject Zinlirvimab Monoclonal antibody Intravenous