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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 - Trial NCT05911360

Access comprehensive clinical trial information for NCT05911360 through Pure Global AI's free database. This Phase 3 trial is sponsored by ViiV Healthcare and is currently Recruiting. The study focuses on HIV. Target enrollment is 200 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05911360
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT05911360
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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

Study Focus

HIV

DTG/3TC

Interventional

drug

Sponsor & Location

ViiV Healthcare

Bakersfield, United States of America

Timeline & Enrollment

Phase 3

Jul 07, 2023

Feb 02, 2026

200 participants

Primary Outcome

Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (≥)50 Copies/Millilitre (c/mL) per Snapshot Algorithm at Week 48

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.

ICD-10 Classifications

Human immunodeficiency virus [HIV] disease
Human immunodeficiency virus [HIV] disease resulting in other conditions
HIV disease resulting in other viral infections
Unspecified human immunodeficiency virus [HIV] disease
Human immunodeficiency virus [HIV] disease resulting in other specified diseases

Data Source

ClinicalTrials.gov

NCT05911360

Non-Device Trial