Phase 2b Study Comparing Oral VH4524184 with Standard HIV Treatment in Adults Newly Diagnosed with HIV-1

What this Trial Is About

Researchers are evaluating a new medication called VH4524184 for treating adults with HIV-1 who have never received treatment before. This Phase 2b study compares two doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide FTCTAF, against a standard HIV treatment combining dolutegravir and lamivudine DTG3TC. The goal is to collect long-term data on the antiviral activity of VH4524184 and to understand the best dosing for future studies. Participants are assigned to one of several groups one group receives a low dose of VH4524184 plus FTCTAF daily for 12 months, another group receives a high dose of VH4524184 plus FTCTAF daily for 12 months, and a third group takes DTG and 3TC daily for 24 months. After 12 months, those on VH4524184 may continue with a selected dose combined with FTCTAF daily until month 24. All medications are taken orally. During the study, participants attend scheduled visits for assessments including blood tests to measure HIV-1 RNA levels, CD4 T-cell counts, and drug concentrations. Researchers monitor the percentage of participants achieving viral suppression at 12 months and maintain it through 24 months. Safety is closely observed through tracking adverse events until roughly month 36. The total participation time may span up to 36 months to evaluate the long-term effects and safety of the treatments.

A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)