AzTrials
AzTrials

HIV InfectionsPhase 3VOLITIONNCT05917509

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

A Phase 3 study testing DTG/3TC, Cabotegravir (CAB) LA and Rilpivirine (RPV) LA in people with HIV Infections, run by ViiV Healthcare at 47 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
DTG/3TC, Cabotegravir (CAB) LA and Rilpivirine (RPV) LA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
47 sitesin 9 countries
Study dates
6 Jul 2023to 20 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 plasma HIV-1 RNA ≥1,000 c/mL at Screening.
  • Antiretroviral-naïve participants (defined as no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) prior to enrolment.
  • Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
  • Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.

Who cannot join

  • Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
  • Participants with any evidence of a current Center 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/cubic millimetre (mm^3) (neither is exclusionary).
  • Participants with 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.
  • Participants with ongoing or clinically relevant pancreatitis.
  • Participants with Clinically significant cardiovascular disease, as defined by recent history (within the last 6 months) or current evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
  • Corrected QT (QTc) interval >450 milliseconds (msec) (or QTc >480 msec for participants with bundle branch block).
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  • Participants with 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 enrolment.
  • Participants with hereditary coagulation and platelet disorders (e.g., haemophilia or von Willebrand Disease); or current or anticipated need for chronic anti-coagulation, with the exception of the use of low-dose acetylsalicylic acid (≤325 mg).
  • Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
  • Participants with 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, or decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per Investigator assessment).
  • Participants with history of liver cirrhosis with or without hepatitis viral co-infection.
  • 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 enrolment 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 enrolment.
  • 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.
  • Participants with signs and symptoms which, in the opinion of the Investigator, are suggestive of active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to enrolment.
  • Evidence of hepatitis B virus (HBV) infection based on the results of testing at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), and hepatitis B surface antibody (anti-HBs) as follows:
  • Participants positive for HBsAg are excluded
  • Participants negative for HBsAg and negative for anti-HBs but positive for anti-HBc are excluded only if HBV DNA is detected [either detected below lower limit of quantification (LLOQ); detected above upper limit of quantification (ULOQ); or numerical value (i.e. between LLOQ and ULOQ)];
  • Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
  • Participants with hepatitis C virus (HCV) co-infection at Screening are eligible only if:
  • liver enzymes meet entry criteria; and
  • 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
  • HCV disease has undergone appropriate work-up and is not advanced or associated with cirrhosis
  • Participants with untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of completed treatment at least 7 days prior to enrolment) 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 enrolment are eligible.
  • Known or suspected presence of any major resistance mutations as defined by the international AIDS society (IAS)-United States of America (USA) resistance guidelines to DTG, 3TC, CAB or RPV in any resistance test result.
  • Participants with 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.
  • Participants with treatment with any of the following agents within 28 days of Screening:
  • radiation therapy
  • cytotoxic chemotherapeutic agents;
  • tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid, INH);
  • anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid (≤325 mg);
  • immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Participants using short-term (e.g. ≤21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment
  • 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 with acyclovir/valacyclovir is permitted.
  • Use of medications which are associated with Torsade de Pointes
  • 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 (m^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKDEPIcr_R) method.
  • Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN); or ALT ≥3xULN and bilirubin ≥1.5xULN (with >35 percentage (%) direct bilirubin).
  • Participants known or suspected to have acquired HIV-1 concurrent with use of protease-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) must be discussed with the Medical Monitor prior to enrolment.
  • Participant has a gluteal implant/enhancements (including fillers); or tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
  • 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 drugs.
  • 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

47 sites in 9 countries.

47 sites in 9 countries

United States15 sites

  • GSK Investigational Site

    Bakersfield, California, 93301

  • GSK Investigational Site

    Beaumont, Texas, 77701

  • GSK Investigational Site

    Berkley, Michigan, 48072

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33308

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982

  • GSK Investigational Site

    Henderson, Nevada, 89106

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Pensacola, Florida, 32504

Other trials in United States

Spain8 sites

  • GSK Investigational Site

    Almería, 04009

  • GSK Investigational Site

    Granada, 35016

  • GSK Investigational Site

    La Laguna-Tenerife, 35010

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Murcia, 30008

  • GSK Investigational Site

    Seville, 41071

Other trials in Spain

France5 sites

  • GSK Investigational Site

    Créteil, 94000

  • GSK Investigational Site

    Orléans, 45067

  • GSK Investigational Site

    Paris, 75004

  • GSK Investigational Site

    Paris, 75015

  • GSK Investigational Site

    Paris, 75475

Other trials in France

Argentina4 sites

  • GSK Investigational Site

    Buenos Aires, C1202

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, 1405

  • GSK Investigational Site

    Mar del Plata, B7600DHK

  • GSK Investigational Site

    Rosario, S2013

Other trials in Argentina

Chile4 sites

  • GSK Investigational Site

    La Cisterna, 7970000

  • GSK Investigational Site

    Providencia, 7500000

  • GSK Investigational Site

    Santiago, 9500000

  • GSK Investigational Site

    Temuco, 4780000

Other trials in Chile

Germany4 sites

  • GSK Investigational Site

    Düsseldorf, 40225

  • GSK Investigational Site

    Frankfurt am Main, 60329

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    München, 80337

Other trials in Germany

Italy4 sites

  • GSK Investigational Site

    Foggia, 71100

  • GSK Investigational Site

    Milan, 20127

  • GSK Investigational Site

    Milan, 20157

  • GSK Investigational Site

    Roma, 00149

Other trials in Italy

Canada2 sites

  • GSK Investigational Site

    Hamilton, Ontario, L8S 1A4

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9

Other trials in Canada

Puerto Rico1 site

  • GSK Investigational Site

    Ponce, 00717-1563

Other trials in Puerto Rico

About this study

Official title: A Phase IIIb, Multi-center, Non-randomized, Parallel-group, Open-label, Hybrid Type I Study Evaluating the Efficacy, Safety, Implementation Effectiveness, and Patient-reported Outcomes of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Followed by Participant-determined Optional Switch to Long-acting Intramuscular Cabotegravir Plus Rilpivirine Every Two Months for the Maintenance of Virologic Suppression in Antiretroviral Therapy Naive Adults Living With HIV-1

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
HIV Infections
Being tested
DTG/3TC, Cabotegravir (CAB) LA, Rilpivirine (RPV) LA
Keywords
HIV-1, dolutegravir, lamivudine, cabotegravir, rilpivirine, Antiretroviral therapy (ART) - naïve, optional switch study, Long-acting, Fixed-dose combination, People living with HIV (PLHIV), Integrase inhibitor
Medical subject headings
HIV Infections

What participants receive

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

  • DTG/3TCDrug

    Also called Dovato

    DTG/3TC FDC will be administered as an oral once daily tablet.

  • Cabotegravir (CAB) LADrug

    Also called Vocabria

    CAB LA will be administered as a gluteal intramuscular injection once every 2 months in combination with RPV LA.

  • Rilpivirine (RPV) LADrug

    Also called Rekambys

    RPV LA will be administered as a gluteal intramuscular injection once every 2 months in combination with CAB LA.

Study groups in NCT05917509
Study groupRoleWhat they receive
Participants Receiving DTG/3TC Fixed Dose Combination (FDC)ExperimentalNot described
Receives: Drug: DTG/3TC
Participants Receiving CAB + RPV LAExperimentalNot described
Receives: Drug: Cabotegravir (CAB) LA; Drug: Rilpivirine (RPV) LA

What is being measured

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

  1. [DTG/3TC]: Time to Virologic Suppression (HIV-1 Ribonucleic Acid [RNA] <50 Copies per Millilitre [c/mL]) From Baseline (Day 1)

    Measured: Baseline (Day 1) up to Month 12

  2. [CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 11

    Measured: Month 11

Secondary outcomes (51)

  1. [DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 12

    Measured: Month 12

  2. [DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL as Per Snapshot Algorithm

    Measured: Month 12

  3. [CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA >= 50 c/mL as Per Snapshot Algorithm

    Measured: Month 11

  4. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Through Day of Choice

    Measured: Up to and including Day of Choice (approximately 20 weeks)

  5. [DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Over Time

    Measured: Up to and including Month 12

  6. [CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Over Time

    Measured: Up to and including Month 11

  7. Absolute Values for Plasma HIV-1 RNA (log10 c/mL) Through Day of choice

    Measured: Up to and including Day of Choice (approximately 20 weeks)

  8. Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) Through Day of Choice

    Measured: Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)

  9. [DTG/3TC]: Absolute Values for Plasma HIV-1 RNA (log10 c/mL) Through Month 12

    Measured: Up to and including Month 12

  10. [DTG/3TC]: Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) Through Month 12

    Measured: Baseline (Day 1) and up to and including Month 12

  11. Absolute Values in Cluster of Differentiation 4 (CD4+) Cell Count Through Day of Choice

    Measured: Up to and including Day of Choice (approximately 20 weeks)

  12. Change From Baseline in CD4+ Cell Count Through Day of Choice

    Measured: Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)

  13. [DTG/3TC]: Absolute Values in CD4+ Cell Count Through Month 12

    Measured: Up to and including Month 12

  14. [DTG/3TC]: Change From Baseline in CD4+ Cell Count Through Month 12

    Measured: Baseline (Day 1) and up to and including Month 12

  15. [CAB + RPV LA]: Absolute Values of CD4+ Cell Count Through Month 11

    Measured: Up to and including Month 11

  16. [CAB + RPV LA]: Change From Baseline in CD4+ Cell Count Through Month 11

    Measured: Baseline (Day 1) and up to and including Month 11

  17. Percentage of Participants Meeting Confirmed Virologic Failure (CVF) Criteria Through Day of Choice

    Measured: Up to and including Day of Choice (approximately 20 weeks)

  18. [DTG/3TC]: Percentage of Participants Meeting CVF Criteria Over Time

    Measured: Up to and including Month 12

  19. [CAB + RPV LA]: Percentage of Participants Meeting CVF Criteria Over Time

    Measured: Up to and including Month 11

  20. Percentage of Participants With Disease Progression Through Day of Choice

    Measured: Up to and including Day of Choice (approximately 20 weeks)

  21. [DTG/3TC]: Percentage of Participants With Disease Progression Over Time

    Measured: Up to and including Month 12

  22. [CAB + RPV LA]: Percentage of Participants With Disease Progression Over Time

    Measured: Up to and including Month 11

  23. Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Day of Choice

    Measured: Up to and including Day of Choice (approximately 20 weeks)

  24. [DTG/3TC]: Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Month 12

    Measured: Up to and including Month 12

  25. [CAB + RPV LA]: Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Month 11

    Measured: Up to and including Month 11

  26. Percentage of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AEs) and AEs Leading to Discontinuation of Study Intervention Through Day of Choice

    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function which meets the definition of Hy's Law.

    Measured: Up to and including Day of Choice (approximately 20 weeks)

  27. [DTG/3TC] Percentage of Participants With SAEs, Drug Related AEs and AEs Leading to Discontinuation of Study Intervention Over Time

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function.

    Measured: Up to and including Month 12

  28. [CAB + RPV LA] Percentage of Participants With SAEs, Drug Related AEs and AEs Leading to Discontinuation of Study Intervention Over Time

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function.

    Measured: Up to and including Month 11

  29. Change From Baseline in Total Treatment Satisfaction Score for HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) to Day of Choice

    HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied) producing a total score ranging from 0 to 66. Higher scores indicate a greater level of participant-reported satisfaction with their current therapy

    Measured: Baseline (Week 4) up to Day of Choice (approximately 20 weeks)

  30. Change From Baseline in Individual Item Score for HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) to Day of Choice

    HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied).

    Measured: Baseline (Week 4) up to Day of Choice (approximately 20 weeks)

  31. [DTG/3TC]: Change From Baseline in Total Treatment Satisfaction Score for HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Months 6 and 12 or up to Withdrawal

    HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied) producing a total score ranging from 0 to 66. Higher scores indicate a greater level of participant-reported satisfaction with their current therapy

    Measured: Baseline (Week 4) and at Month 6 and 12

  32. [DTG/3TC]: Change From Baseline in Individual Item Scores for HIVTSQs at Months 6 and 12 or up to Withdrawal

    HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied).

    Measured: Baseline (Week 4) and at Month 6 and 12

  33. [CAB + RPV LA]: Change From Baseline in Total Treatment Satisfaction Score for HIVTSQs at Months 5 and 11 or up to Withdrawal

    HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied) producing a total score ranging from 0 to 66. Higher scores indicate a greater level of participant-reported satisfaction with their current therapy

    Measured: Baseline (Week 4) and at Month 5 and 11

  34. [CAB + RPV LA]: Change From Baseline in Individual Item Scores for HIVTSQs at Months 5 and 11 or up to Withdrawal

    HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied).

    Measured: Baseline (Week 4) and at Month 5 and 11

  35. Change From Baseline in Total Score of HIV Related Symptoms Assessed by Symptom Distress Module (SDM) Through Day of Choice

    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. Each item is rated from 0 (complete absence of symptom) to 4 (very bothersome symptom). Overall score is calculated as the sum of the scores for each of the 20 items of the questionnaire and ranges from 0 (best health) to 80 (worst health).

    Measured: Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)

  36. Change From Baseline in Individual Bothersome Symptoms of HIV Assessed by SDM Through Day of Choice

    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. Each item is rated from 0 (complete absence of symptom) to 4 (very bothersome symptom).

    Measured: Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)

  37. [DTG/3TC]: Change From Baseline in Total Score of HIV Related Symptoms Assessed by SDM at Month 6 and 12

    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. Each item is rated from 0 (complete absence of symptom) to 4 (very bothersome symptom). Overall score is calculated as the sum of the scores for each of the 20 items of the questionnaire and ranges from 0 (best health) to 80 (worst health).

    Measured: Baseline (Day 1) and at Month 6 and 12

  38. [DTG/3TC]: Change From Baseline in Individual Bothersome Symptoms of HIV Assessed by SDM at Month 6 and 12

    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. Each item is rated from 0 (complete absence of symptom) to 4 (very bothersome symptom).

    Measured: Baseline (Day 1) and at Month 6 and 12

  39. Change From Baseline in Health-Related Quality of Life Using World Health Organisation Quality of Life Brief version (WHOQoL-HIV-BREF) Through Day of Choice

    WHOQoL-HIV-BREF is a 31-item self-reported measure that addresses the 6 quality of life domains including (physical, psychological, level of independence, social relations, environment, spiritual) and 2 general health presence. The scales domain score ranges from 4 to 20. Higher scores indicate a better quality of life.

    Measured: Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)

  40. [CAB + RPV LA]: Change From Baseline in Health-Related Quality of Life Using WHOQoL-HIV-BREF at Month 5 and 11

    WHOQoL-HIV-BREF is a 31-item self-reported measure that addresses the 6 quality of life domains including (physical, psychological, level of independence, social relations, environment, spiritual) and 2 general health presence. The scales domain score ranges from 4 to 20. Higher scores indicate a better quality of life.

    Measured: Baseline (Day 1) and at Month 5 and 11

  41. [DTG/3TC]: Change From Baseline in Health-Related Quality of Life Using WHOQoL-HIV-BREF at Month 6 and 12

    WHOQoL-HIV-BREF is a 31-item self-reported measure that addresses the 6 quality of life domains including (physical, psychological, level of independence, social relations, environment, spiritual) and 2 general health presence. The scales domain score ranges from 4 to 20. Higher scores indicate a better quality of life.

    Measured: Baseline (Day 1) and at Month 6 and 12

  42. Change From Baseline in Anxiety and Depression Score Using Patient Health Questionnaire 9 (PHQ-9) Through Day of Choice

    PHQ-9 is a 9-item scale that assesses mood symptoms over past two weeks. Each item is rated from 0 to 3 and yields a total score range of 0-27. Higher score indicates severe depression.

    Measured: Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)

  43. [DTG/3TC]: Change From Baseline in Anxiety and Depression Score Using PHQ-9 at Month 6 and 12

    PHQ-9 is a 9-item scale that assesses mood symptoms over past two weeks. Each item is rated from 0 to 3 and yields a total score range of 0-27. Higher score indicates severe depression.

    Measured: Baseline (Day 1) and at Month 6 and 12

  44. [CAB + RPV LA]: Change From Baseline in Anxiety and Depression Score Using PHQ-9 at Month 5 and 11

    PHQ-9 is a 9-item scale that assesses mood symptoms over past two weeks. Each item is rated from 0 to 3 and yields a total score range of 0-27. Higher score indicates severe depression.

    Measured: Baseline (Day 1) and at Month 5 and 11

  45. Change From Baseline in Anxiety and Depression Score Using General Anxiety Disorder 7 (GAD-7) Through Day of Choice

    GAD-7 is a 7-item scale that assesses GAD symptoms over past two weeks. Each item is rated from 0 to 3 and yields a total score range of 0-21. Higher score indicates severe anxiety.

    Measured: Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)

  46. [DTG/3TC]: Change From Baseline in Anxiety and Depression Score Using GAD-7 at Month 6 and 12

    GAD-7 is a 7-item scale that assesses GAD symptoms over past two weeks. Each item is rated from 0 to 3 and yields a total score range of 0-21. Higher score indicates severe anxiety.

    Measured: Baseline (Day 1) and at Month 6 and 12

  47. [CAB + RPV LA]: Change From Baseline in Anxiety and Depression Score Using GAD-7 at Month 5 and 11

    GAD-7 is a 7-item scale that assesses GAD symptoms over past two weeks. Each item is rated from 0 to 3 and yields a total score range of 0-21. Higher score indicates severe anxiety.

    Measured: Baseline (Day 1) and at Month 5 and 11

  48. Percentage of Participants Providing Response to Single Item Bespoke Questions From Baseline to Day of Choice

    Bespoke single-item questions are developed by ViiV Healthcare to assess concepts such as stigma, feelings about diagnosis, low mood/excitement relating to treatment.

    Measured: Baseline (Day 1) and Day of Choice (approximately 20 weeks)

  49. [CAB + RPV LA]: Percentage of Participants Providing Response to Single Item Bespoke Questions From Day of Choice to Month 5 and 11

    Bespoke single-item questions are developed by ViiV Healthcare to assess concepts such as stigma, feelings about diagnosis, low mood/excitement relating to treatment.

    Measured: Day of Choice (approximately 20 weeks) up to Month 5 and 11

  50. [DTG/3TC]: Percentage of Participants Providing Response to Single Item Bespoke Questions From Day of Choice to Month 6 and 12

    Bespoke single-item questions are developed by ViiV Healthcare to assess concepts such as stigma, feelings about diagnosis, low mood/excitement relating to treatment.

    Measured: Day of Choice (approximately 20 weeks) up to Month 6 and 12

  51. [CAB + RPV LA]: Percentage of Participants Providing Response to Assessments Using ViiV Healthcare Developed Single Item Questionnaire From Day of Choice to Month 5 and 11

    Bespoke single-item questions developed by ViiV Healthcare to assess long-acting specific concepts such as fear of disclosure of HIV status, adherence anxiety and daily reminder of HIV status.

    Measured: Day of Choice (approximately 20 weeks) up to Month 5 and 11

Timeline

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

  1. First posted26 Jun 2023
  2. Study start6 Jul 2023
  3. Primary completion16 Sep 2025
  4. Study completion20 Apr 2026

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917509
Sponsor's protocol ID
219700
Other IDs
2023-503893-19-00, 2023
Acronym
VOLITION
Status last verified
May 2026
First submitted
13 Jun 2023
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Publications

  • Cordova E, Rolle CP, Hove K, Felizarta F, Johnson M, Cuevas Tascon G, Molina JM, Bravo Urbieta J, Hocqueloux L, Lupo S, Perez CM, Ole Jensen BE, Jonsson-Oldenbuttel C, Zamora Vargas FX, Szabo J, Cahn P, Antinori A, Lopez Bernaldo de Quiros JC, Castagna A, Bui M, Grove R, Wang K, St Clair M, Moodley R, Radford J, Priest J, Gutner CA, Jacob I, Chatterjee A, Somvanshi S, Kolobova I, Trehan R, Polk C, Patel P, de Los Rios P, DiMondi P, Gordon LA, Brown K, Garges HP, Jones B, van Wyk J. Rapid Virologic Suppression With Dolutegravir Plus Lamivudine Facilitates Early Switch to Long-Acting Cabotegravir Plus Rilpivirine for Treatment-Naive People With HIV-1: Month 11/12 Outcomes From the Phase 3b VOLITION Study. Open Forum Infect Dis. 2026 Jul 25;13(9):ofag383. doi: 10.1093/ofid/ofag383. eCollection 2026 Sep.

    PubMed 42812355

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTG/3TC, Cabotegravir (CAB) LA and Rilpivirine (RPV) LA in people with HIV Infections, run by ViiV Healthcare at 47 sites in 9 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 4 inclusion and 44 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: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Spain, France, Argentina, Chile and 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

[DTG/3TC]: Time to Virologic Suppression (HIV-1 Ribonucleic Acid [RNA] <50 Copies per Millilitre [c/mL]) From Baseline (Day 1) (time frame: Baseline (Day 1) up to Month 12). The study lists 2 primary outcomes in all. 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 NCT05917509, 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 27 May 2026.

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