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Older adults with HIV may safely switch to a simpler two-drug pill

NCT ID NCT05911360

Disease control Sponsor: ViiV Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study looked at whether adults aged 50 and older living with HIV could safely switch from a three-drug pill to a simpler two-drug pill (DTG/3TC) while keeping the virus under control. About 200 participants who already had undetectable virus levels made the switch and were followed for 48 weeks. The goal was to see if the simpler pill worked just as well at maintaining viral suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

205 people

The number who actually took part.

Started

Jul 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants living with HIV-1 and had documented plasma HIV-1 RNA \<50 c/mL within 3 months prior to Screening. * Participants had been on uninterrupted ART for ≥1 year (except for brief periods \[less than 30 days\] where all ART had been stopped due to tolerability and/or safety concerns). * Participants had been on uninterrupted BIC/FTC/TAF for at least 6 months prior to Screening. * Participants had plasma HIV-1 RNA \<50 c/mL at Screening. * Participants had no known prior regimen switches due to documented virologic failure (defined as a confirmed plasma HIV-1 RNA ≥200 c/mL). * Participants with unknown full treatment/clinical history beyond 5 years prior to Screening may have been eligible upon discussion and agreement with the medical monitor. Exclusion Criteria: * Women participants were pregnant or breastfeeding or planned to become pregnant or breastfeed during the study. * Participants had any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/cubic millimetre (mm\^3) were not exclusionary. * Participants had signs and symptoms which, in the opinion of the investigator, were suggestive of active severe acute respiratory syndrome-related coronavirus (SARS-CoV-2) infection within 14 days prior to enrolment. * Participants had severe hepatic impairment (Class C) as determined by Child-Pugh classification. * Evidence of hepatitis B virus (HBV) infection was based on the results of testing at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: 1. Participants positive for HBsAg were excluded; 2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, were excluded; 3. Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) were immune to HBV and were not excluded. * Participants had unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). * Participants had a history of liver cirrhosis with or without hepatitis viral co-infection. * Participants had untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who were at least 7 days post completed treatment were eligible. * Participants had a history or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicated their participation. * Participants had ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia. * Participants who, in the investigator's judgment, posed a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation was considered when evaluating for suicide risk. * Participants had any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major Integrase strand transfer inhibitor (INSTI) resistance associated mutation in any available prior resistance genotype assay test result. All available historical resistance reports with HIV-1 reverse transcriptase or integrase genotypic data were provided to ViiV after screening and before enrollment for review by ViiV Virology. * Participants had any verified Grade 4 laboratory abnormality with the exception of Grade 4 lipid abnormalities. Alanine aminotransferase (ALT) was ≥5 times the upper limit of normal (ULN) or ALT was ≥3×ULN and bilirubin was ≥1.5×ULN (\>35% direct bilirubin). \- Participants had estimated creatine clearance \<30 mL/min per 1.73 square meter (m\^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr\_R) method.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV HIV infections

Contacts and locations

Locations

  • GSK Investigational Site

    Phoenix, Arizona, 85015, United States

  • GSK Investigational Site

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    Palm Springs, California, 92262, United States

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20005, United States

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982, United States

  • GSK Investigational Site

    Miami, Florida, 33133, United States

  • GSK Investigational Site

    West Palm Beach, Florida, 33407, United States

  • GSK Investigational Site

    Augusta, Georgia, 30912, United States

  • GSK Investigational Site

    Decatur, Georgia, 30033, United States

  • GSK Investigational Site

    Macon, Georgia, 31201, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02043, United States

  • GSK Investigational Site

    Berkley, Michigan, 48072, United States

  • GSK Investigational Site

    Detroit, Michigan, 48202, United States

  • GSK Investigational Site

    Kansas City, Missouri, 64111, United States

  • GSK Investigational Site

    Omaha, Nebraska, 68198, United States

  • GSK Investigational Site

    Las Vegas, Nevada, 89106, United States

  • GSK Investigational Site

    The Bronx, New York, 10467, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    Greensboro, North Carolina, 27401, United States

  • GSK Investigational Site

    Wilmington, North Carolina, 28401-7684, United States

  • GSK Investigational Site

    Akron, Ohio, 44304, United States

  • GSK Investigational Site

    Portland, Oregon, 97239, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Austin, Texas, 78705, United States

  • GSK Investigational Site

    Innsbruck, 6020, Austria

  • GSK Investigational Site

    Vienna, 1100, Austria

  • GSK Investigational Site

    Brussels, 1200, Belgium

  • GSK Investigational Site

    Ghent, 9000, Belgium

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2L 1N9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    Nice, 6202, France

  • GSK Investigational Site

    Orléans, 45100, France

  • GSK Investigational Site

    Paris, 75004, France

  • GSK Investigational Site

    Freiburg im Breisgau, 79106, Germany

  • GSK Investigational Site

    Hanover, 30625, Germany

  • GSK Investigational Site

    München, 80336, Germany

  • GSK Investigational Site

    Milan, 20142, Italy

  • GSK Investigational Site

    Modena, 41100, Italy

  • GSK Investigational Site

    Roma, 161, Italy

  • GSK Investigational Site

    Torino, 10149, Italy

  • GSK Investigational Site

    Mérida, 97070, Mexico

  • GSK Investigational Site

    Monterrey, 64460, Mexico

  • GSK Investigational Site

    Amsterdam, 1105 AZ, Netherlands

  • GSK Investigational Site

    Rotterdam, 3079 DZ, Netherlands

  • GSK Investigational Site

    Utrecht, 3584 CX, Netherlands

  • GSK Investigational Site

    Porto, 4099-001, Portugal

  • GSK Investigational Site

    Porto, 4200-319, Portugal

  • GSK Investigational Site

    Vila Nova de Gaia, 4434-502, Portugal

  • GSK Investigational Site

    Manresa, Catalonia, 08243, Spain

  • GSK Investigational Site

    Sabadell, Catalonia, 8208, Spain

  • GSK Investigational Site

    Guadalajara, 19002, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Liverpool, L7 8XP, United Kingdom

  • GSK Investigational Site

    London, SE1 9RT, United Kingdom

  • GSK Investigational Site

    London, SW7 2AZ, United Kingdom

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Other studies related to the condition(s) this trial covers.