Active, not recruitingNCT05979311VOGUEUpdated Jul 2, 2026

A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

A Phase 3 interventional study of Dolutegravir and Lamivudine in HIV and HIV Infections, sponsored by ViiV Healthcare. Active, not recruiting at 64 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by ViiV Healthcare · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 307
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.

Conditions studied

HIV
HIV Infections

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Keywords

Antiretroviral-naïve
Bictegravir
Dolutegravir
Emtricitabine
Human immunodeficiency virus 1 (HIV-1)
Lamivudine
Virologic suppression
Tenofovir alafenamide

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 307 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Fib-4 score >3.25 is exclusionary;
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 307 participants (actual)

Study arms

Experimental
DTG/3TC
Participants will receive FDC of DTG/3TC once daily until Week 96.
Drug: Dolutegravir · Drug: Lamivudine
Active comparator
BIC/FTC/TAF
Participants will receive BIC/FTC/TAF once daily until Week 96.
Drug: Bictegravir · Drug: Emtricitabine · Drug: Tenofovir alafenamide

Interventions

DrugDolutegravir
Dolutegravir will be administered once daily.
DrugLamivudine
Lamivudine will be administered once daily.
DrugBictegravir
Bictegravir will be administered once daily.
DrugEmtricitabine
Emtricitabine will be administered once daily.
DrugTenofovir alafenamide
Tenofovir alafenamide will be administered once daily.

What researchers measure

Primary outcomes

Percentage of participants with plasma HIV- Ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) as per snapshot algorithm at Week 48
Time frame: Week 48

Secondary outcomes

Percentage of participants with plasma HIV-1 RNA <50 c/mL as per snapshot algorithm at Weeks 24 and 96
Time frame: Weeks 24 and 96
Percentage of participants with HIV-RNA greater than or equal to (>=)50 c/mL as per snapshot algorithm at Weeks 24, 48, and 96
Time frame: Weeks 24, 48 and 96
Change from Baseline in HIV-1 RNA at Weeks 24, 48 and 96
Time frame: Baseline (Day 1) and Weeks 24, 48 and 96
Change from Baseline in Cluster of differentiation 4 positive (CD4+) cell count at Weeks 24, 48 and 96
Time frame: Baseline (Day 1) and Weeks 24, 48 and 96
Change from Baseline in CD4/Cluster of differentiation 8 (CD8) at Weeks 24, 48 and 96
Time frame: Baseline (Day 1) and Weeks 24, 48 and 96
Number of Participants With HIV-1 Disease Progression
Time frame: Weeks 24, 48 and 96
Time to virologic suppression (HIV-1 RNA <50 c/mL) from Baseline
Time frame: Baseline (Day 1) and Up to Week 96
Number of participants with confirmed virologic withdrawal (CVW)
Time frame: Up to Week 96
Number of Participants with treatment-emergent resistance
Time frame: Up to week 96
Change from Baseline in Renal Biomarkers- estimated glomerular filtration rate at Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in Renal Biomarkers- urinary protein/creatinine at Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in renal biomarker- Serum Cystatin C at Weeks 48 and 96 (Milligrams per liter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in renal biomarker- Serum Retinol Binding Protein (RBP) at Weeks 48 and 96 (Milligrams per deciliter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in renal biomarker- Serum Beta-2 Microglobulin (B2M) at Weeks 48 and 96 (Micrograms per milliliter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in bone biomarkers- Serum Bone Specific Alkaline Phosphatase, Serum Procollagen type 1 N- Propeptide, Serum Type I Collagen C-Telopeptides and Serum Osteocalcin at Weeks 48 and 96 (Micrograms per Liter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in bone biomarkers- Serum Vitamin D at Weeks 48 and 96 (Nanomoles per Liter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline (Week 4) in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction status Questionnaire (HIVTSQs) at Weeks 12, 24, 48 and 96 (Scores on a scale)
The HIVTSQ status version (HIVTSQs) is assessing participants' satisfaction with their current treatment with a Total score ranging from 0 to 60. Higher scores indicate a greater level of satisfaction with HIV treatment. Baseline is defined as measurement value at Week 4.
Time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
Change from Baseline (Week 4) in Individual Item Scores Using HIVTSQs at Weeks12, 24, 48 and 96 (Scores on a scale)
Individual items scores range from 0 to 6 (0=very dissatisfied, 6=very satisfied). Baseline is defined as measurement value at Week 4.
Time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
Change from Baseline (Week 4) in Domains Scores Using HIVTSQs at Weeks 12, 24, 48 and 96 (Scores on a scale)
There are two domain scores of General Satisfaction/Clinical and Lifestyle/Ease subscales; each comprised of 5 items with possible scores of 0 to 30. The higher the score, the greater the satisfaction within the subscale. Baseline is defined as measurement value at Week 4.
Time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
Change from Baseline in bothersome symptoms using the Symptom Distress Module at Weeks 4, 12, 24, 48 and 96 (Score on a scale)
The Symptom Distress Module (SDM) is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom bother score is based on the score for each symptom present ranging from 1 (it does not bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score).
Time frame: Baseline (Day 1) and Weeks 4, 12, 24, 48 and 96
Absolute values for waist and hip circumference (Centimeters)
Time frame: Up to Week 96
Absolute values for waist to hip ratio and waist to height ratio (Ratio)
Time frame: Up to Week 96
Absolute values for Body weight (Kilogram)
Time frame: Up to Week 96
Absolute values for systolic and diastolic blood pressure (millimeters of mercury)
Time frame: Up to Week 96
Change from Baseline in Body Mass Index (kilogram per square meter)
Time frame: Baseline (Day 1) and Up to Week 96
Change from Baseline in body weight greater than (>) 5 percentage (%) at Weeks 24, 48 and 96
Time frame: Baseline (Day 1) and Weeks 24, 48 and 96
Change from Baseline in total and regional (trunk and extremities) fat assessed by Dual-energy X-ray absorptiometry (DXA) at Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in total and regional (trunk and extremities) fat-free mass assessed by DXA Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in lumbar and hip bone mineral density (BMD) assessed by DXA at Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in trabecular bone score (TBS) assessed by DXA at Weeks 48 and 96
Trabecular bone score (TBS) is a lumbar spine dual-energy absorptiometry texture index, which provides information on microarchitecture skeletal quality partially independent of BMD.
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in fasting glucose (Millimoles per Liter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in insulin (Microunits per millilliter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 and Week 96
Time frame: Baseline (Day 1), Week 48 and Week 96
Change from Baseline in Hemoglobin A1c [HbA1c] at Week 48 and Week 96 (Percentage of HbA1c)
Time frame: Baseline (Day 1), Week 48 and Week 96
Change from Baseline in plasma lipids (total, high-density lipoprotein [HDL], and low-density lipoprotein [LDL] cholesterol, triglycerides) (Millimoles per Liter) at Week 48 and Week 96
Time frame: Baseline (Day 1), Week 48 and Week 96
Change from Baseline in QDiabetes Score at Week 48 and Week 96 (Scores on a scale)
QDiabetes score defines the risk (percentage) of developing type 2 Diabetes in the next ten years. The score ranges from 0-100.
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in Fibrosis 4 (FIB-4) Score at Week 48 and Week 96 (Scores on a scale)
A value of FIB-4 scores below 1.30 is considered as low risk for advanced fibrosis; value of FIB-4 over 2.67 is considered as high risk for advanced fibrosis; and FIB-4 values between 1.30 and 2.67 are considered as intermediate risk of advanced fibrosis.
Time frame: Baseline (Day 1), Weeks 48 and 96
Number of participants with metabolic syndrome at Weeks 48 and 96
Time frame: Weeks 48 and 96
Change from Baseline in Framingham cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale)
Coronary heart disease (CHD) risk at 10 years in percent (%) can be calculated with the help of the Framingham Risk Score. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in Data collection on Adverse events of anti-HIV Drugs (DAD) cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale)
Coronary heart disease (CHD) risk at 5 years in percent can be calculated with the help of the DAD Risk Score. The 5-year risk of CHD is classified as low (\<1%), moderate (1 to 5%), high (5 to 10%), or very high (\>10%).
Time frame: Baseline (Day 1), Weeks 48 and 96
Changes from Baseline in Systolic and diastolic blood pressure at Weeks 48 and 96 millimeters of mercury (mmHg)
Time frame: Baseline (Day 1), Weeks 48 and 96

Study locations

64 sites

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

References and documents

Individual participant data

Plan to share: Yes — ViiV will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05979311
Lead sponsor: ViiV Healthcare
Responsible party: Sponsor
First posted: Aug 7, 2023
Start date: Feb 21, 2024
Primary completion: Apr 15, 2026
Completion: Feb 23, 2027 (estimated)
Last update: Jul 2, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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