Pilot Phase 2 Study of DoravirineLamivudineTenofovir Disoproxil Fumarate DOR3TCTDF Switch in Adults with Controlled HIV and M184VI Mutation

What this Trial Is About

This clinical trial studies adults living with HIV who have controlled viral loads but previously developed the M184VI mutation, which causes resistance to lamivudine 3TC. Researchers aim to evaluate how well the combination of Doravirine, Lamivudine, and Tenofovir Disproxyl Fumarate DOR3TCTDF maintains viral suppression 24 weeks after switching to this regimen, with follow-up continuing to 48 weeks. The study also investigates changes in metabolism, weight, and HIV-DNA mutations over time. Participants will switch from their current antiretroviral treatment to a single pill combining Doravirine 100 mg, Lamivudine 300 mg, and Tenofovir disoproxil fumarate 245 mg Delstrigo, taken once daily for 48 weeks. This is a single-arm, open-label phase 2 trial, so all participants receive this combination without placebo comparison. During the study, participants will have their HIV-RNA levels carefully monitored at 24 and 48 weeks after the switch. Researchers will assess viral suppression, metabolic and weight changes, and mutation patterns. The trial includes regular visits and evaluations over the 48-week treatment period to track the effects and safety of switching to DOR3TCTDF.

DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)