NCT05295394

Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pedro Cahn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Dolutegravir plus lamivudine	Dolutegravir 50 mg QD plus lamivudine 300 mg QD

Timeline

• Start date: 2019-05-22
• Primary completion: 2022-08-01
• Completion: 2022-08-30
• First posted: 2022-03-25
• Last updated: 2022-04-12

Locations

2 sites across 1 country: Argentina