New Two-Drug HIV pill could match Three-Drug standard

NCT ID NCT05979311

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

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether a simpler two-drug pill (dolutegravir/lamivudine) works as well as a standard three-drug pill (bictegravir/emtricitabine/tenofovir alafenamide) for adults with HIV who have never been treated. About 473 participants will take one of the two pills daily for up to 96 weeks. The main goal is to see if the two-drug regimen keeps the virus under control just as effectively.

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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

307 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

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

18 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 with age \>=18 years (or older, if required by local regulations) at the time of obtaining informed consent. * An individual participant is eligible to participate if they are not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrollment) and not lactating. * Antiretroviral-naïve (no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) person living with HIV. * Participant (or participant's legally acceptable representative \[LAR\]) is capable of giving written informed consent. * Eligible participants or their LAR must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures. * Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category. Exclusion Criteria: * Individuals who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study. * Any evidence of a current Centers for Disease Control and Prevention (CDC) Stage 3 disease; with the exception of cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ count \<200 cells per cubic millimeter (neither is exclusionary). * History or presence of allergy or intolerance to the study drugs 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, contraindicates study participation. * Ongoing or clinically relevant pancreatitis. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the Investigator and the Medical Monitor for inclusion of the participant prior to enrollment. * Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification. * 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). * History of liver cirrhosis with or without hepatitis viral co-infection. * Alanine aminotransferase (ALT) \>=5 times the upper limit of normal (ULN) or ALT \>=3\*ULN and bilirubin \>=1.5\*ULN (with \>35% direct bilirubin). * Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment. * Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. * Signs and symptoms which, in the opinion of the Investigator, are suggestive of active Coronavirus disease 2019 (COVID-19) (example fever, cough) infection within 14 days prior to enrollment. * Evidence of Hepatitis B virus (HBV) infection based on the results of central lab testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb) and HBV Deoxyribonucleic Acid (DNA) as follows: a. Participants positive for HBsAg are excluded; b. Participants negative for HBsAb and negative for HBsAg but positive for hepatitis B core antibody (HBcAb) may be excluded based on the following consideration: i. Exclude if HBV DNA is detected \[either \<Lower Limit of Quantification (LLoQ), \>Upper Limit of Quantification (ULoQ) OR numerical value (i.e., between LLoQ and ULoQ)\] ii. Not excluded if HBV DNA is negative, not detected * Participants with Hepatitis C virus (HCV) co-infection at Screening are eligible only if: i. liver enzymes meet entry criteria; and ii. HCV disease is not anticipated to require on-study treatment with any agent(s) that have potential adverse drug-drug interactions (DDIs) with the study interventions; and iii. HCV disease has undergone appropriate work-up and is not advanced and will not require treatment prior to the primary endpoint or later visit. Additional information on participants with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. iv. In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility 1. Fib-4 score \>3.25 is exclusionary; 2. Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation. Fibrosis 4 score Formula: (Age \* Aspartate aminotransferase \[AST\]) / (Platelets \* (square root of ALT) * Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment) are excluded. Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor. Participants who completed treatment at least 7 days prior to Screening are eligible. * Presence of any major resistance-associated mutations as defined by the International Antiviral Society-United States of America (IAS-USA) resistance guidelines to DTG, 3TC, BIC, FTC or TAF in the Screening result. * Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent (whichever is longer), prior to first dose of study treatment. * Treatment with any of the following agents within 28 days of Screening: i. radiation therapy; ii. cytotoxic chemotherapeutic agents; iii. tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid, INH); iv. immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. * Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of first dose of study treatment. Treatment withacyclovir/valacyclovir is permitted. * Participants receiving any protocol-defined prohibited medication and who are unwilling or unable to switch to an alternate medication. * Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. * Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in an interventional clinical trial. * Participant has estimated creatine clearance \<30 milliliter per minute (mL/min) per 1.73 square meter using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr\_R) method. * Participants known or suspected to have acquired HIV-1 concurrent with use of Pre-exposure prophylaxis (PrEP) or Post-exposure prophylaxis (PEP) must be discussed with the Medical Monitor prior to enrollment. * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication. * Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Participant is currently participating in, or anticipates being selected for, any other interventional study.

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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

Ciudad Autonoma de Buenos Aire, C1425AWK, Argentina
GSK Investigational Site

Córdoba, X5000JJS, Argentina
GSK Investigational Site

Antwerp, 2000, Belgium
GSK Investigational Site

Brussels, 1000, Belgium
GSK Investigational Site

Ghent, 9000, Belgium
GSK Investigational Site

Hvidovre, 2650, Denmark
GSK Investigational Site

Bordeaux, 33000, France
GSK Investigational Site

Bordeaux, 33076, France
GSK Investigational Site

Lyon, 31059, France
GSK Investigational Site

Montpellier, 34090, France
GSK Investigational Site

Nice, 06202, France
GSK Investigational Site

Nîmes, 30029, France
GSK Investigational Site

Paris, 75012, France
GSK Investigational Site

Paris, 75013, France
GSK Investigational Site

Paris, 75018, France
GSK Investigational Site

Paris, 75970, France
GSK Investigational Site

Berlin, 10787, Germany
GSK Investigational Site

Cologne, 50668, Germany
GSK Investigational Site

Frankfurt, 60590, Germany
GSK Investigational Site

Hamburg, 20146, Germany
GSK Investigational Site

München, 80336, Germany
GSK Investigational Site

Athens, 106 76, Greece
GSK Investigational Site

Athens, 11 527, Greece
GSK Investigational Site

Thessaloniki, 54635, Greece
GSK Investigational Site

Dublin, 7, Ireland
GSK Investigational Site

Dublin, D09 V2N0, Ireland
GSK Investigational Site

Haifa, 31096, Israel
GSK Investigational Site

Ramat Gan, 52621, Israel
GSK Investigational Site

Rehovot, 76100, Israel
GSK Investigational Site

Tel Aviv, 64239, Israel
GSK Investigational Site

Bari, 70124, Italy
GSK Investigational Site

Bergamo, 24127, Italy
GSK Investigational Site

Padova, 35128, Italy
GSK Investigational Site

Pavia, 27100, Italy
GSK Investigational Site

Sassari, 07100, Italy
GSK Investigational Site

Aichi, 460-0001, Japan
GSK Investigational Site

Osaka, 540-0006, Japan
GSK Investigational Site

Tokyo, 108-8639, Japan
GSK Investigational Site

Tokyo, 162-8655, Japan
GSK Investigational Site

Mérida, 97070, Mexico
GSK Investigational Site

Bydgoszcz, 85-030, Poland
GSK Investigational Site

Lodz, 91-347, Poland
GSK Investigational Site

Wroclaw, 50-136, Poland
GSK Investigational Site

Aveiro, 3814-501, Portugal
GSK Investigational Site

Porto, 4099-001, Portugal
GSK Investigational Site

Badalona, 08916, Spain
GSK Investigational Site

Barcelona, 08036, Spain
GSK Investigational Site

Elche Alicante, 03203, Spain
GSK Investigational Site

La Laguna-Tenerife, 35010, Spain
GSK Investigational Site

Madrid, 28040, Spain
GSK Investigational Site

Madrid, 28041, Spain
GSK Investigational Site

Madrid, 28046, Spain
GSK Investigational Site

Marbella, 29603, Spain
GSK Investigational Site

Palma de Mallorca, 07120, Spain
GSK Investigational Site

Palma de Mallorca, 7198, Spain
GSK Investigational Site

Valencia, 46014, Spain
GSK Investigational Site

Stockholm, SE-14186, Sweden
GSK Investigational Site

Basel, 4031, Switzerland
GSK Investigational Site

Zurich, 8005, Switzerland
GSK Investigational Site

Glasgow, G12 OYN, United Kingdom
GSK Investigational Site

London, E9 6SR, United Kingdom
GSK Investigational Site

London, SE5 8AF, United Kingdom
GSK Investigational Site

London, W1D 6AQ, United Kingdom
GSK Investigational Site

London, W2 1NY, United Kingdom

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