NCT04549467

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Fundacion IDEAA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hiv
• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Lamivudine 300 MG	Experimental arm
DRUG	Emtricitabine / Tenofovir Disoproxil Pill	Active Comparator

Timeline

• Start date: 2020-11-17
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2020-09-16
• Last updated: 2024-02-21

Locations

1 site across 1 country: Argentina