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NCT05911360Recruiting

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
ViiV HealthcarePhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
HIV
Drug/Device/Intervention
DTG/3TC
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
ViiV Healthcare
Location
Bakersfield, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Jul 07, 2023
End date
Feb 02, 2026
Enrollment
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] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHIV disease resulting in other viral infectionsUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other specified diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05911360
Type
Non-Device Trial
About this record

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.