A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens

Condition studied

HIV-1

Investigational medicinal product(s)

Every trial of Cobicistat, Doravirine, Ritonavir and Tenofovir DF across our registers →

Eligibility

Primary endpoint

Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as defined by the US FDA snapshot algorithm.

Endpoint detail

Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 92 as defined by the US FDA snapshot algorithm., Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 52 and 92 as determined by the US FDA snapshot algorithm., Changes from baseline in CD4+ T-cell counts at Weeks 52 and 92., Proportion of participants experiencing TEAEs., Proportion of participants prematurely discontinuing their study treatment due to an AE., Trough concentrations at Weeks 26, 52, and 104 for LEN, TAB, and ZAB., Incidence of ADAs and neutralizing antibodies (NAbs) of TAB and ZAB.