Efficacy of Dolutegravir Plus Lamivudine in HIV-1-infected Treatment-naïve Adults Without a Baseline Genotyping Test — D2ARLING  

Hiv Clinical Trial

Official title: Efficacy of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults Without Baseline Genotyping Test (D2ARLING Study)

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of DTG + 3TC versus DTG + TDF/FTC over 48 weeks in HIV-1 naive patients in a real life setting with no baseline HIV genotypic resistance testing available.

Clinical Trial Description

This is a 48-week, Phase IV, randomized, open-label, to assess the non-inferior antiviral activity (VL < 50 c/ml) of 2DR DTG+3TC versus 3DR TDF/FTC + DTG over 48 weeks in HIV1 naïve adult patients without baseline GT available at Day 1 visit. Subjects will be stratified by screening HIV-1 RNA (≤100,000 c/mL or >100,000 c/mL) and Screening CD4+ cell count (≤ or >200 cells/mm3).

The study will comprise:

• a 28-day Screening Phase (which may be extended to 35 days to allow receipt of all Screening assessment results).

• an Open-label Randomized Phase (Day 1 to Week 48).

Approximately 200 HIV-1 naïve adult patients will be randomized 1:1 to receive 2DR DTG+3TC versus 3DR TDF/FTC + DTG for 48 weeks. ;

Related Conditions & MeSH terms

• Hiv
• HIV-1-infection

• NCT number: NCT04549467
• Study type: Interventional
• Source: Fundacion IDEAA
• Status: Completed
• Phase: Phase 4
• Start date: November 17, 2020
• Completion date: September 30, 2023