HIV-1 Infection Clinical Trial
Official title:
Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study
The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV patients with a documented M184V mutation.
This is a pilot study designed to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV-1 subjects ≥ 18 years old carrying the M184V mutation This will be evaluated as the proportion of patients with pVL < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot). This study will consist of a screening period of up to 42 days, a 48-week treatment period, followed by a 4-week post-treatment follow-up (FU) period to document late adverse events. The study will include 20 HIV-1-infected subjects, meeting all inclusion criteria and not meeting any exclusion criteria for this study. ;
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