A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1

• Published in: Pragmatic and observational research 2022-01, Vol.13, p.75-84
• Main Authors: Dravid, Ameet, Morkar, Dnyanesh, Prasad, Dwijendra, Ramapuram, John T, Patel, Kartik Vikrambhai, Naik, K Sunil, Bhrusundi, Milind, Kulkarni, Milind, Hegde, Sanjeev, Anuradha, S, Nageswaramma, Siddabathuni, Madan, Surabhi, Jayaprakash, Thammisetty, Kulkarni, Vinay
• Format: Article
• Language: English
• Subjects: AIDS treatment; Analysis; Anti-HIV agents; Antiviral agents; Clinical trials; Compliance; Demographics; Drug dosages; Drug resistance; Drug therapy; Health aspects; HIV; HIV (Viruses); HIV patients; Human immunodeficiency virus; Infection; Medical research; Medicine, Experimental; Original Research; Patient compliance; Plasma; Respiratory tract diseases; Reverse transcriptase inhibitors; Statistical analysis
• ISSN: 1179-7266; 1179-7266
• DOI: 10.2147/POR.S361907

Purpose: WHO recommends dolutegravir (DTG) based regimens as first-line treatment for HIV-1 infection. However, few studies have been conducted in Indian population. Hence, our study evaluated the safety, tolerability, and efficacy of DTG 50 mg with Tenofovir and Lamivudine (300/300mg) fixed dose combination in treatment naive adult Indian patients. Methods: This was an open label, multicenter, prospective, interventional, phase IV study conducted across 14 sites between February 2019 and July 2020. 24 weeks was the treatment duration for each subject. The primary end point was to assess the incidence of adverse events (AEs) and secondary end points were to assess the proportion of patients achieving plasma HIV-1 RNA levels