NCT05979311

A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive Adults Living With HIV

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.

Conditions

• HIV
• HIV Infections

Interventions

Type	Name	Description
DRUG	Dolutegravir	Dolutegravir will be administered once daily.
DRUG	Lamivudine	Lamivudine will be administered once daily.
DRUG	Bictegravir	Bictegravir will be administered once daily.
DRUG	Emtricitabine	Emtricitabine will be administered once daily.
DRUG	Tenofovir alafenamide	Tenofovir alafenamide will be administered once daily.

Timeline

• Start date: 2024-02-09
• Primary completion: 2026-03-24
• Completion: 2027-02-23
• First posted: 2023-08-07
• Last updated: 2025-12-05

Locations

64 sites across 17 countries: Argentina, Belgium, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom