Evaluating the Dual Combination of Doravirine and Raltegravir to Maintain Viral Suppression in HIV-1 Infected Patients with Controlled HIV RNA Under Current Treatment

What this Trial Is About

Researchers are evaluating a new dual antiretroviral therapy combining doravirine and raltegravir in adults living with HIV-1 who have achieved viral suppression under their current treatment. The goal is to maintain this viral control while reducing the long-term toxic effects and drug interactions commonly seen with traditional triple-drug HIV therapies. This phase II trial focuses on older patients, many of whom face age-related health challenges such as cardiovascular disease, bone loss, and kidney dysfunction, all of which can be worsened by long-term antiretroviral drug use. Participants will be randomly assigned to either switch immediately to the once-daily dual therapy doravirine plus raltegravir or to continue their current antiretroviral regimen for 48 weeks before switching to the dual therapy. The study lasts a total of 96 weeks, allowing researchers to compare the effects of early versus delayed switching. Doravirine and raltegravir are chosen for their potent antiviral activity and favorable safety profiles, including fewer expected drug interactions. During the study, participants will undergo regular assessments including viral load measurements to monitor HIV control, immune system evaluations, and metabolic health checks. The primary outcome is the effectiveness of the dual therapy at maintaining viral suppression at 48 weeks. Safety, tolerance, and the impact on metabolic and general health symptoms will also be closely observed over the full 96-week period.

HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label