Virological and Immunological Assessment in HIV Positive Participants on Dual Therapy Versus Triple Therapy in a Randomized Switch Trial

What this Trial Is About

Researchers are studying HIV-1 infected adults who are currently on a stable triple drug regimen to see how switching to a dual therapy affects the virus and immune system. This trial compares dual therapy with dolutegravir and lamivudine DTG3TC, Dovato against a triple regimen with bictegravir, tenofovir alafenamide, and emtricitabine BICTAFFTC, Biktarvy. The main goal is to check if the dual therapy is not worse than the triple therapy in terms of the amount of intact HIV virus in blood cells after 48 weeks, while monitoring immune activation and inflammation markers. Participants will be randomly assigned to either continue their triple therapy or to switch to dual therapy. The study includes a 48-week primary period and extends up to 240 weeks to assess longer-term effects. Researchers will measure viral sequences, immune system markers, metabolic health indicators like weight and insulin resistance, and body composition using scans such as DXA and FibroScan. Patient experiences will also be evaluated through questionnaires. During the study, participants will attend regular visits for blood sample collection and assessments of viral load, immune function, metabolic health, and liver condition. These include measuring markers like interleukin-6, C-reactive protein, T cell activation and exhaustion indicators, and others. The study aims to ensure safety and monitor any health complications over nearly five years. Participants must agree to ongoing blood sample storage for research and complete scheduled assessments throughout the study.

2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial