Dolutegravir Plus Lamivudine Simplified Therapy

Dolutegravir (DTG) is one type of integrase inhibitor, lamivudine (3TC) is one type of reverse transcriptase inhibitor, both of which are HIV medicine prevents HIV from self-multiplying, reduces the viral load. The data of the existing randomized controlled clinical studies show that the simplified two-drug DTG-based regimen is similar to the three-drug regimen in terms of efficacy, but there are no relevant data and reports on the efficacy and safety of DTG+3TC in HIV-infected patients in China so far. This project aims to explore the efficacy and safety of the DTG + 3TC regimen for HIV-infected patients in real clinical environment, to guide clinical application, and to provide a theoretical basis for the selection of simplified schemes for the formulation of guidelines. This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV.

NCT Number	NCT03884673
Lead Sponsor	Guangzhou 8th People's Hospital Collaborators: Shenzhen Third People's Hospital, Dongguan People's Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, The Third People's Hospital of Guilin, Guangxi Longtan hospital, The Fourth People's Hospital of Nanning, The Third People's Hospital of Kunming, Yunnan AIDS Care Center, Meng Chao Hepatobiliary Hospital of Fujian Medical University, First Affiliated Hospital of Guangxi Medical University
Conditions	HIV/AIDS
Enrollment	300 participants
Start Date	2019-01-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2022-09-14