NCT05911360

A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF

A Phase 3b, Multicenter, Single-arm, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to DTG/3TC Single Tablet Regimen Administered Once Daily From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in People Living With HIV of at Least 50 Years of Age Who Are Virologically Suppressed

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

Conditions

• HIV
• HIV Infections

Interventions

Type	Name	Description
DRUG	DTG/3TC	DTG/3TC FDC will be administered once daily.

Timeline

• Start date: 2023-01-31
• Primary completion: 2025-02-24
• Completion: 2026-01-13
• First posted: 2023-06-22
• Last updated: 2025-12-01

Locations

56 sites across 12 countries: United States, Austria, Belgium, Canada, France, Germany, Italy, Mexico, Netherlands, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study