Study of Dolutegravir and Lamivudine Combination Therapy for HIV-1 Patients Evaluating Safety and Effectiveness in Real-World Treatment

What this Trial Is About

Researchers are evaluating a simplified treatment for HIV using a combination of two anti-HIV medicines, dolutegravir DTG and lamivudine 3TC, taken once daily. This study aims to explore the safety and effectiveness of this two-drug regimen in HIV-infected patients in China, as previous studies have shown similar results compared to traditional three-drug treatments but lack data from the Chinese population. The goal is to guide clinical use and provide a solid basis for treatment guidelines. This open-label, phase IV clinical trial involves 300 HIV-infected patients who switch to a simplified regimen of 50 mg DTG plus 400 mg 3TC taken orally once daily. The study observes the treatments effectiveness by measuring viral suppression rates and immune cell counts at weeks 24, 36, 48, and 96. Safety and medication adherence are also monitored throughout the trial. Participants will have their viral load and CD4CD8 immune cell counts assessed regularly over 96 weeks, along with monitoring for any adverse events and treatment compliance. The study involves multiple follow-up visits to track immune function changes and viral control. This long-term observation provides valuable data on how well the simplified therapy works and how safe it is for patients living with HIV.

Dolutegravir Plus Lamivudine Simplified Therapy