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NCT05917509 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy
A Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 3
- Development phase
- 171
- Enrollment target
- 20
- Study locations
NCT05917509: Active Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
NCT05917509 is a Phase 3 study of HIV Infections that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 171 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05917509, a Phase 3 study of HIV Infections, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 171 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA). All participants will initially receive DTG/3TC once daily, and once virologic suppression is attained (plasma HIV-1 \<50 c/mL), participants will be offered a choice to switch to CAB + RPV LA or to continue taking oral DTG/3TC. This study will provide important data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes of these two regimens in a study where participants have the option to choose between them based on individual preference. The aim of the study is to evaluate the antiviral effectiveness at 11 months after switching to CAB+RPV LA following initial virologic suppression on DTG/3TC and to provide data on how long it takes participants to suppress their viral load on DTG/3TC.
Conditions Studied
Interventions
- DRUG DTG/3TC
- DRUG Cabotegravir (CAB) LA
- DRUG Rilpivirine (RPV) LA
Study Locations (20)
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Ft. Pierce
- GSK Investigational Site - Orlando
- GSK Investigational Site - Pensacola
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Ciudad Autonoma de Bueno
- GSK Investigational Site - Mar del Plata
- GSK Investigational Site - Rosario
Texas
- GSK Investigational Site - Beaumont
- GSK Investigational Site - Dallas
- GSK Investigational Site - Fort Worth
North Carolina
- GSK Investigational Site - Charlotte
- GSK Investigational Site - Huntersville
Alabama
- GSK Investigational Site - Birmingham
California
- GSK Investigational Site - Bakersfield
Michigan
- GSK Investigational Site - Berkley
Missouri
- GSK Investigational Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2023-07-06 |
| Est. Completion | 2026-04-22 |
| Phase | Phase 3 |
What the registry record for NCT05917509 still lists
NCT05917509 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (62% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which DTG/3TC is the first listed.
NCT05917509 names 20 study sites across 11 states, led by Florida, Other, Texas.
Frequently Asked Questions
What is clinical trial NCT05917509 about?
NCT05917509 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy". This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of d...
What is the current status of trial NCT05917509?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 171 participants. The study started on 2023-07-06. Estimated completion is 2026-04-22.
What conditions does trial NCT05917509 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT05917509?
The interventions under investigation include: DTG/3TC (DRUG), Cabotegravir (CAB) LA (DRUG), Rilpivirine (RPV) LA (DRUG).
Who is sponsoring clinical trial NCT05917509?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05917509 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05917509's enrollment target sits among peer trials
171 195th of 542 higher than 348 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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