Dolutegravir is an Integrase inhibitor approved by US FDA on 13 August 2013. It is indicated in combination with other antiretroviral agents to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric subjects weighing at least 30 kg. This study aims to evaluate the safety and assess the effectiveness of Dolutegravir in causing HIV-1 suppression in combination with other ARVs in HIV-1 infected subjects. National AIDS Research Institute is conducting this study through 10 sites all over India. PHG is one of the sites for this study. As per DCGI recommendation, 275 HIV 1 positive adult participants will be enrolled in the study.

Objectives:

• To assess the frequency of any adverse event in subjects initiated on Dolutegravir based regimen.
• To assess the frequency of any SAE after initiating DTG based regimen.
• To explore the risk factors for the development of AE/SAE.
• To assess the frequency of AE and SAE attributable to DTG.
• To determine the time to discontinuation of antiretroviral regimen due to any adverse event.
• To evaluate the effectiveness of Dolutegravir based regimens in achieving or maintaining virologic suppression in combination with other ARVs in HIV-1 infected subjects.
• To assess trends in CD4 and CD8 counts and CD4:CD8 over the study period

Type of research: Open-Label, Non-Randomized, Non-Controlled, Multi-Center, Phase IV Trial

Investigators:

Dr. Abhijeet Kadam (Principal Investigator from lead research institute NARI)

Dr. Vinay Kulkarni (Prayas site Principal Investigator)

Funding: Emcure Pharmaceuticals Ltd.

CTRI number: CTRI/2018/03/012576

Start date: July 2018 (Recruitment started at Prayas site)

End date:  December 2022