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HIVPhase 3VOGUENCT05979311

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 study testing Dolutegravir, Lamivudine and Bictegravir in people with HIV and HIV Infections, run by ViiV Healthcare at 64 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, HIV Infections
What is being tested?
Dolutegravir, Lamivudine and Bictegravir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
463 participants
Where
64 sitesin 17 countries
Study dates
21 Feb 2024to 26 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 36Show fewer
  • 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:
  • 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:
  • 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.
  • 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:
  • 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.

Trial locations and contacts

64 sites in 17 countries.

64 sites in 17 countries

Spain11 sites

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Elche Alicante, 03203

  • GSK Investigational Site

    La Laguna-Tenerife, 35010

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Marbella, 29603

  • GSK Investigational Site

    Palma de Mallorca, 07120

  • GSK Investigational Site

    Palma de Mallorca, 7198

  • GSK Investigational Site

    Valencia, 46014

Other trials in Spain

France10 sites

  • GSK Investigational Site

    Bordeaux, 33000

  • GSK Investigational Site

    Bordeaux, 33076

  • GSK Investigational Site

    Lyon, 31059

  • GSK Investigational Site

    Montpellier, 34090

  • GSK Investigational Site

    Nice, 06202

  • GSK Investigational Site

    Nîmes, 30029

  • GSK Investigational Site

    Paris, 75012

  • GSK Investigational Site

    Paris, 75013

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Paris, 75970

Other trials in France

Germany5 sites

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Cologne, 50668

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Hamburg, 20146

  • GSK Investigational Site

    München, 80336

Other trials in Germany

Italy5 sites

  • GSK Investigational Site

    Bari, 70124

  • GSK Investigational Site

    Bergamo, 24127

  • GSK Investigational Site

    Padova, 35128

  • GSK Investigational Site

    Pavia, 27100

  • GSK Investigational Site

    Sassari, 07100

Other trials in Italy

United Kingdom5 sites

  • GSK Investigational Site

    Glasgow, Lanarkshire, G12 OYN

  • GSK Investigational Site

    London, E9 6SR

  • GSK Investigational Site

    London, SE5 8AF

  • GSK Investigational Site

    London, W1D 6AQ

  • GSK Investigational Site

    London, W2 1NY

Other trials in United Kingdom

Israel4 sites

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Rehovot, 76100

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Japan4 sites

  • GSK Investigational Site

    Aichi, 460-0001

  • GSK Investigational Site

    Osaka, 540-0006

  • GSK Investigational Site

    Tokyo, 108-8639

  • GSK Investigational Site

    Tokyo, 162-8655

Other trials in Japan

Belgium3 sites

  • GSK Investigational Site

    Antwerp, 2000

  • GSK Investigational Site

    Brussels, Brussels Capital, 1000

  • GSK Investigational Site

    Ghent, 9000

Other trials in Belgium

Greece3 sites

  • GSK Investigational Site

    Athens, 106 76

  • GSK Investigational Site

    Athens, 11 527

  • GSK Investigational Site

    Thessaloniki, 54635

Other trials in Greece

Poland3 sites

  • GSK Investigational Site

    Bydgoszcz, 85-030

  • GSK Investigational Site

    Lodz, 91-347

  • GSK Investigational Site

    Wroclaw, 50-136

Other trials in Poland

Argentina2 sites

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1425AWK

  • GSK Investigational Site

    Córdoba, X5000JJS

Other trials in Argentina

Ireland2 sites

  • GSK Investigational Site

    Dublin, 7

  • GSK Investigational Site

    Dublin, D09 V2N0

Other trials in Ireland

Portugal2 sites

  • GSK Investigational Site

    Aveiro, 3814-501

  • GSK Investigational Site

    Porto, 4099-001

Other trials in Portugal

Switzerland2 sites

  • GSK Investigational Site

    Basel, Canton of Basel-City, 4031

  • GSK Investigational Site

    Zurich, 8005

Other trials in Switzerland

Denmark1 site

  • GSK Investigational Site

    Hvidovre, 2650

Other trials in Denmark

Mexico1 site

  • GSK Investigational Site

    Mérida, 97070

Other trials in Mexico

Sweden1 site

  • GSK Investigational Site

    Stockholm, SE-141 86

Other trials in Sweden

About this study

Official title: A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive Adults Living With HIV

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
HIV, HIV Infections
Being tested
Dolutegravir, Lamivudine, Bictegravir, Emtricitabine, Tenofovir alafenamide
Keywords
Antiretroviral-naïve, Bictegravir, Dolutegravir, Emtricitabine, Human immunodeficiency virus 1 (HIV-1), Lamivudine, Virologic suppression, Tenofovir alafenamide
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DolutegravirDrug

    Dolutegravir will be administered once daily.

  • LamivudineDrug

    Lamivudine will be administered once daily.

  • BictegravirDrug

    Bictegravir will be administered once daily.

  • EmtricitabineDrug

    Emtricitabine will be administered once daily.

  • Tenofovir alafenamideDrug

    Tenofovir alafenamide will be administered once daily.

Study groups in NCT05979311
Study groupRoleWhat they receive
DTG/3TCExperimentalParticipants will receive FDC of DTG/3TC once daily until Week 96.
Receives: Drug: Dolutegravir; Drug: Lamivudine
BIC/FTC/TAFActive comparatorParticipants will receive BIC/FTC/TAF once daily until Week 96.
Receives: Drug: Bictegravir; Drug: Emtricitabine; Drug: Tenofovir alafenamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 48

Secondary outcomes (41)

  1. Percentage of participants with plasma HIV-1 RNA <50 c/mL as per snapshot algorithm at Weeks 24 and 96

    Measured: Weeks 24 and 96

  2. Percentage of participants with HIV-RNA greater than or equal to (>=)50 c/mL as per snapshot algorithm at Weeks 24, 48, and 96

    Measured: Weeks 24, 48 and 96

  3. Change from Baseline in HIV-1 RNA at Weeks 24, 48 and 96

    Measured: Baseline (Day 1) and Weeks 24, 48 and 96

  4. Change from Baseline in Cluster of differentiation 4 positive (CD4+) cell count at Weeks 24, 48 and 96

    Measured: Baseline (Day 1) and Weeks 24, 48 and 96

  5. Change from Baseline in CD4/Cluster of differentiation 8 (CD8) at Weeks 24, 48 and 96

    Measured: Baseline (Day 1) and Weeks 24, 48 and 96

  6. Number of Participants With HIV-1 Disease Progression

    Measured: Weeks 24, 48 and 96

  7. Time to virologic suppression (HIV-1 RNA <50 c/mL) from Baseline

    Measured: Baseline (Day 1) and Up to Week 96

  8. Number of participants with confirmed virologic withdrawal (CVW)

    Measured: Up to Week 96

  9. Number of Participants with treatment-emergent resistance

    Measured: Up to week 96

  10. Change from Baseline in Renal Biomarkers- estimated glomerular filtration rate at Weeks 48 and 96

    Measured: Baseline (Day 1), Weeks 48 and 96

  11. Change from Baseline in Renal Biomarkers- urinary protein/creatinine at Weeks 48 and 96

    Measured: Baseline (Day 1), Weeks 48 and 96

  12. Change from Baseline in renal biomarker- Serum Cystatin C at Weeks 48 and 96 (Milligrams per liter)

    Measured: Baseline (Day 1), Weeks 48 and 96

  13. Change from Baseline in renal biomarker- Serum Retinol Binding Protein (RBP) at Weeks 48 and 96 (Milligrams per deciliter)

    Measured: Baseline (Day 1), Weeks 48 and 96

  14. Change from Baseline in renal biomarker- Serum Beta-2 Microglobulin (B2M) at Weeks 48 and 96 (Micrograms per milliliter)

    Measured: Baseline (Day 1), Weeks 48 and 96

  15. 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)

    Measured: Baseline (Day 1), Weeks 48 and 96

  16. Change from Baseline in bone biomarkers- Serum Vitamin D at Weeks 48 and 96 (Nanomoles per Liter)

    Measured: Baseline (Day 1), Weeks 48 and 96

  17. 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.

    Measured: Baseline (Week 4) and Weeks 12, 24, 48 and 96

  18. 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.

    Measured: Baseline (Week 4) and Weeks 12, 24, 48 and 96

  19. 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.

    Measured: Baseline (Week 4) and Weeks 12, 24, 48 and 96

  20. 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).

    Measured: Baseline (Day 1) and Weeks 4, 12, 24, 48 and 96

  21. Absolute values for waist and hip circumference (Centimeters)

    Measured: Up to Week 96

  22. Absolute values for waist to hip ratio and waist to height ratio (Ratio)

    Measured: Up to Week 96

  23. Absolute values for Body weight (Kilogram)

    Measured: Up to Week 96

  24. Absolute values for systolic and diastolic blood pressure (millimeters of mercury)

    Measured: Up to Week 96

  25. Change from Baseline in Body Mass Index (kilogram per square meter)

    Measured: Baseline (Day 1) and Up to Week 96

  26. Change from Baseline in body weight greater than (>) 5 percentage (%) at Weeks 24, 48 and 96

    Measured: Baseline (Day 1) and Weeks 24, 48 and 96

  27. Change from Baseline in total and regional (trunk and extremities) fat assessed by Dual-energy X-ray absorptiometry (DXA) at Weeks 48 and 96

    Measured: Baseline (Day 1), Weeks 48 and 96

  28. Change from Baseline in total and regional (trunk and extremities) fat-free mass assessed by DXA Weeks 48 and 96

    Measured: Baseline (Day 1), Weeks 48 and 96

  29. Change from Baseline in lumbar and hip bone mineral density (BMD) assessed by DXA at Weeks 48 and 96

    Measured: Baseline (Day 1), Weeks 48 and 96

  30. 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.

    Measured: Baseline (Day 1), Weeks 48 and 96

  31. Change from Baseline in fasting glucose (Millimoles per Liter)

    Measured: Baseline (Day 1), Weeks 48 and 96

  32. Change from Baseline in insulin (Microunits per millilliter)

    Measured: Baseline (Day 1), Weeks 48 and 96

  33. Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 and Week 96

    Measured: Baseline (Day 1), Week 48 and Week 96

  34. Change from Baseline in Hemoglobin A1c [HbA1c] at Week 48 and Week 96 (Percentage of HbA1c)

    Measured: Baseline (Day 1), Week 48 and Week 96

  35. 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

    Measured: Baseline (Day 1), Week 48 and Week 96

  36. 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.

    Measured: Baseline (Day 1), Weeks 48 and 96

  37. 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.

    Measured: Baseline (Day 1), Weeks 48 and 96

  38. Number of participants with metabolic syndrome at Weeks 48 and 96

    Measured: Weeks 48 and 96

  39. 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.

    Measured: Baseline (Day 1), Weeks 48 and 96

  40. 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%).

    Measured: Baseline (Day 1), Weeks 48 and 96

  41. Changes from Baseline in Systolic and diastolic blood pressure at Weeks 48 and 96 millimeters of mercury (mmHg)

    Measured: Baseline (Day 1), Weeks 48 and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start21 Feb 2024
  3. Primary completion15 Apr 2026
  4. Study completion26 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979311
Sponsor's protocol ID
219816
Other IDs
2023-504993-40-00, 2023
Acronym
VOGUE
Status last verified
Oct 2026
First submitted
19 Jul 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

Publications

  • Ghosn J, Pulido F, Lopardo GD, Olczak A, Ripamonti D, Martin C, Paredes Ceballos O, Stocker H, Mendez Vazquez MJ, Gatanaga H, Metallidis S, Elbirt D, Whitlock G, Mateo Gonzalez JI, Mohammed P, Wang K, Grove R, Wang R, Jewell A, Sutton K, Elliot E, Moodley R, Borsi R, Jones B, Kisare M, Budnik P, van Wyk J; VOGUE Study Group; VOGUE Study Group. VOGUE: Noninferior Efficacy of Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-1 Naive to Treatment. Open Forum Infect Dis. 2026 Jul 28;13(8):ofag471. doi: 10.1093/ofid/ofag471. eCollection 2026 Aug.

    PubMed 42597905

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dolutegravir, Lamivudine and Bictegravir in people with HIV and HIV Infections, run by ViiV Healthcare at 64 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Spain, France, Germany, Italy, United Kingdom and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05979311, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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