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Clinical Trial Summary

First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens. Thus, there is great interest from subjects and clinicians in unique regimens that might avoid such toxicities by minimizing the number of antiretrovirals without sacrificing long-term antiviral efficacy. DTG plus 3TC is a novel, well-tolerated first-line regimen for HIV-infected treatment- naive subjects, limiting the risk of many common adverse reactions associated with other antiretroviral drugs. Thus, this study is designed to evaluate the efficacy and safety of DTG/3TC as a FDC, in ART-naive HIV-1-infected adolescents, who weigh at least 40 kilograms. The study will consists of Screening Phase (up to 28 days prior to the first dose of drug) followed by Treatment Phase (up to 48 weeks). Subjects who successfully complete 48 weeks of therapy and who continue to receive benefit from DTG/3TC FDC may enter a 96-week study Extension Phase. All subjects will receive the FDC of DTG/3TC (50/300 milligrams) for once daily. Approximately 30 subjects will be enrolled in the study.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03682848
Study type Interventional
Source ViiV Healthcare
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Status Not yet recruiting
Phase Phase 3
Start date October 29, 2018
Completion date December 29, 2023

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