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NCT05911360 · ClinicalTrials.gov registry record · Phase 3
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 3 study of HIV Infections and HIV, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 3
- Development phase
- 205
- Enrollment target
- 20
- Study locations
NCT05911360: Active Phase 3 study of HIV Infections and HIV, sponsored by ViiV Healthcare.
NCT05911360 is a Phase 3 study of HIV Infections and HIV that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 205 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05911360, a Phase 3 study of HIV Infections and HIV, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 205 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Participants with HIV-1 RNA \>= 50 c/mL were evaluated. Virologic outcome was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the Week 48 Window. The analysis was done using the modified Snapshot algorithm.
Conditions Studied
Interventions
- DRUG DTG/3TC
Study Locations (20)
Florida
- GSK Investigational Site - Ft. Pierce
- GSK Investigational Site - Miami
- GSK Investigational Site - West Palm Beach
Georgia
- GSK Investigational Site - Augusta
- GSK Investigational Site - Decatur
- GSK Investigational Site - Macon
North Carolina
- GSK Investigational Site - Charlotte
- GSK Investigational Site - Greensboro
- GSK Investigational Site - Wilmington
California
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Palm Springs
Michigan
- GSK Investigational Site - Berkley
- GSK Investigational Site - Detroit
Arizona
- GSK Investigational Site - Phoenix
District of Columbia
- GSK Investigational Site - Washington D.C.
Massachusetts
- GSK Investigational Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2026-01-13 |
| Phase | Phase 3 |
What the registry record for NCT05911360 still lists
NCT05911360 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which DTG/3TC is the first listed.
NCT05911360 names 20 study sites across 12 states, led by Florida, Georgia, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05911360 about?
NCT05911360 is a clinical study titled "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". 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) wh...
What is the current status of trial NCT05911360?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 205 participants. The study started on 2023-01-31. Estimated completion is 2026-01-13.
What conditions does trial NCT05911360 study?
This clinical trial studies the following conditions: HIV Infections, HIV.
What interventions are being tested in trial NCT05911360?
The interventions under investigation include: DTG/3TC (DRUG).
Who is sponsoring clinical trial NCT05911360?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05911360 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05911360's enrollment target sits among peer trials
205 168th of 542 higher than 374 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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