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ACTIVE NOT RECRUITING 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

NCT05917509 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 171 participants
Start Date 2023-07-06
Est. Completion 2026-04-22
Phase Phase 3

Sponsor

ViiV Healthcare

82 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05917509

The ClinicalTrials.gov registry entry for NCT05917509 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05917509 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Other, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05917509?

The interventions under investigation include: DTG/3TC (DRUG), Cabotegravir (CAB) LA (DRUG), Rilpivirine (RPV) LA (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05917509?

This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial