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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 (VOLITION)

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DTG/3TC
Cabotegravir (CAB) LA
Rilpivirine (RPV) LA
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants having 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. Exclusion Criteria: 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). 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 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. Participants with 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 the Screening result; or, if known, in any historical 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.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participants Receiving DTG/3TC Fixed Dose Combination (FDC)

Participants Receiving CAB + RPV LA

Arm Description

Outcomes

Primary Outcome Measures

[DTG/3TC]: Time to Virologic Suppression (HIV-1 Ribonucleic Acid [RNA] <50 Copies per Millilitre [c/mL]) From Baseline (Day 1)
[CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 11

Secondary Outcome Measures

[DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 12
[DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL as Per Snapshot Algorithm
[CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA >= 50 c/mL as Per Snapshot Algorithm
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Through Day of Choice
[DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Over Time
[CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Over Time
Absolute Values for Plasma HIV-1 RNA (log10 c/mL) Through Day of choice
Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) Through Day of Choice
[DTG/3TC]: Absolute Values for Plasma HIV-1 RNA (log10 c/mL) Through Month 12
[DTG/3TC]: Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) Through Month 12
Absolute Values in Cluster of Differentiation 4 (CD4+) Cell Count Through Day of Choice
Change From Baseline in CD4+ Cell Count Through Day of Choice
[DTG/3TC]: Absolute Values in CD4+ Cell Count Through Month 12
[DTG/3TC]: Change From Baseline in CD4+ Cell Count Through Month 12
[CAB + RPV LA]: Absolute Values of CD4+ Cell Count Through Month 11
[CAB + RPV LA]: Change From Baseline in CD4+ Cell Count Through Month 11
Percentage of Participants Meeting Confirmed Virologic Failure (CVF) Criteria Through Day of Choice
[DTG/3TC]: Percentage of Participants Meeting CVF Criteria Over Time
[CAB + RPV LA]: Percentage of Participants Meeting CVF Criteria Over Time
Percentage of Participants With Disease Progression Through Day of Choice
[DTG/3TC]: Percentage of Participants With Disease Progression Over Time
[CAB + RPV LA]: Percentage of Participants With Disease Progression Over Time
Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Day of Choice
[DTG/3TC]: Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Month 12
[CAB + RPV LA]: Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Month 11
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.
[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.
[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.
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
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).
[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
[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).
[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
[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).
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).
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).
[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).
[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).
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.
[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.
[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.
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.
[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.
[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.
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.
[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.
[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.
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.
[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.
[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.
[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.

Full Information

First Posted
June 13, 2023
Last Updated
July 17, 2023
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline, PPD
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1. Study Identification

Unique Protocol Identification Number
NCT05917509
Brief Title
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
Acronym
VOLITION
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
September 29, 2025 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline, PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants Receiving DTG/3TC Fixed Dose Combination (FDC)
Arm Type
Experimental
Arm Title
Participants Receiving CAB + RPV LA
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DTG/3TC
Intervention Description
DTG/3TC FDC will be administered as an oral once daily tablet.
Intervention Type
Drug
Intervention Name(s)
Cabotegravir (CAB) LA
Intervention Description
CAB LA will be administered as an intramuscular injection once every 2 months in combination with RPV LA.
Intervention Type
Drug
Intervention Name(s)
Rilpivirine (RPV) LA
Intervention Description
RPV LA will be administered as an intramuscular injection once every 2 months in combination with CAB LA.
Primary Outcome Measure Information:
Title
[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
Title
[CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 11
Time Frame
Month 11
Secondary Outcome Measure Information:
Title
[DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 12
Time Frame
Month 12
Title
[DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL as Per Snapshot Algorithm
Time Frame
Month 12
Title
[CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA >= 50 c/mL as Per Snapshot Algorithm
Time Frame
Month 11
Title
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Through Day of Choice
Time Frame
Up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Over Time
Time Frame
Up to and including Month 12
Title
[CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Over Time
Time Frame
Up to and including Month 11
Title
Absolute Values for Plasma HIV-1 RNA (log10 c/mL) Through Day of choice
Time Frame
Up to and including Day of Choice (approximately 20 weeks)
Title
Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) Through Day of Choice
Time Frame
Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Absolute Values for Plasma HIV-1 RNA (log10 c/mL) Through Month 12
Time Frame
Up to and including Month 12
Title
[DTG/3TC]: Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) Through Month 12
Time Frame
Baseline (Day 1) and up to and including Month 12
Title
Absolute Values in Cluster of Differentiation 4 (CD4+) Cell Count Through Day of Choice
Time Frame
Up to and including Day of Choice (approximately 20 weeks)
Title
Change From Baseline in CD4+ Cell Count Through Day of Choice
Time Frame
Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Absolute Values in CD4+ Cell Count Through Month 12
Time Frame
Up to and including Month 12
Title
[DTG/3TC]: Change From Baseline in CD4+ Cell Count Through Month 12
Time Frame
Baseline (Day 1) and up to and including Month 12
Title
[CAB + RPV LA]: Absolute Values of CD4+ Cell Count Through Month 11
Time Frame
Up to and including Month 11
Title
[CAB + RPV LA]: Change From Baseline in CD4+ Cell Count Through Month 11
Time Frame
Baseline (Day 1) and up to and including Month 11
Title
Percentage of Participants Meeting Confirmed Virologic Failure (CVF) Criteria Through Day of Choice
Time Frame
Up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Percentage of Participants Meeting CVF Criteria Over Time
Time Frame
Up to and including Month 12
Title
[CAB + RPV LA]: Percentage of Participants Meeting CVF Criteria Over Time
Time Frame
Up to and including Month 11
Title
Percentage of Participants With Disease Progression Through Day of Choice
Time Frame
Up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Percentage of Participants With Disease Progression Over Time
Time Frame
Up to and including Month 12
Title
[CAB + RPV LA]: Percentage of Participants With Disease Progression Over Time
Time Frame
Up to and including Month 11
Title
Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Day of Choice
Time Frame
Up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Month 12
Time Frame
Up to and including Month 12
Title
[CAB + RPV LA]: Percentage of Participants With Viral Resistance to CAB, RPV, DTG and 3TC Through Month 11
Time Frame
Up to and including Month 11
Title
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
Description
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.
Time Frame
Up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC] Percentage of Participants With SAEs, Drug Related AEs and AEs Leading to Discontinuation of Study Intervention Over Time
Description
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.
Time Frame
Up to and including Month 12
Title
[CAB + RPV LA] Percentage of Participants With SAEs, Drug Related AEs and AEs Leading to Discontinuation of Study Intervention Over Time
Description
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.
Time Frame
Up to and including Month 11
Title
Change From Baseline in Total Treatment Satisfaction Score for HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) to Day of Choice
Description
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
Time Frame
Baseline (Week 4) up to Day of Choice (approximately 20 weeks)
Title
Change From Baseline in Individual Item Score for HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) to Day of Choice
Description
HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied).
Time Frame
Baseline (Week 4) up to Day of Choice (approximately 20 weeks)
Title
[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
Description
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
Time Frame
Baseline (Week 4) and at Month 6 and 12
Title
[DTG/3TC]: Change From Baseline in Individual Item Scores for HIVTSQs at Months 6 and 12 or up to Withdrawal
Description
HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied).
Time Frame
Baseline (Week 4) and at Month 6 and 12
Title
[CAB + RPV LA]: Change From Baseline in Total Treatment Satisfaction Score for HIVTSQs at Months 5 and 11 or up to Withdrawal
Description
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
Time Frame
Baseline (Week 4) and at Month 5 and 11
Title
[CAB + RPV LA]: Change From Baseline in Individual Item Scores for HIVTSQs at Months 5 and 11 or up to Withdrawal
Description
HIVTSQ is a 12-item self-reported scale. Individual items are rated from 0 (very dissatisfied) to 6 (very satisfied).
Time Frame
Baseline (Week 4) and at Month 5 and 11
Title
Change From Baseline in Total Score of HIV Related Symptoms Assessed by Symptom Distress Module (SDM) Through Day of Choice
Description
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).
Time Frame
Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)
Title
Change From Baseline in Individual Bothersome Symptoms of HIV Assessed by SDM Through Day of Choice
Description
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).
Time Frame
Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Change From Baseline in Total Score of HIV Related Symptoms Assessed by SDM at Month 6 and 12
Description
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).
Time Frame
Baseline (Day 1) and at Month 6 and 12
Title
[DTG/3TC]: Change From Baseline in Individual Bothersome Symptoms of HIV Assessed by SDM at Month 6 and 12
Description
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).
Time Frame
Baseline (Day 1) and at Month 6 and 12
Title
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
Description
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.
Time Frame
Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)
Title
[CAB + RPV LA]: Change From Baseline in Health-Related Quality of Life Using WHOQoL-HIV-BREF at Month 5 and 11
Description
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.
Time Frame
Baseline (Day 1) and at Month 5 and 11
Title
[DTG/3TC]: Change From Baseline in Health-Related Quality of Life Using WHOQoL-HIV-BREF at Month 6 and 12
Description
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.
Time Frame
Baseline (Day 1) and at Month 6 and 12
Title
Change From Baseline in Anxiety and Depression Score Using Patient Health Questionnaire 9 (PHQ-9) Through Day of Choice
Description
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.
Time Frame
Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Change From Baseline in Anxiety and Depression Score Using PHQ-9 at Month 6 and 12
Description
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.
Time Frame
Baseline (Day 1) and at Month 6 and 12
Title
[CAB + RPV LA]: Change From Baseline in Anxiety and Depression Score Using PHQ-9 at Month 5 and 11
Description
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.
Time Frame
Baseline (Day 1) and at Month 5 and 11
Title
Change From Baseline in Anxiety and Depression Score Using General Anxiety Disorder 7 (GAD-7) Through Day of Choice
Description
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.
Time Frame
Baseline (Day 1) and up to and including Day of Choice (approximately 20 weeks)
Title
[DTG/3TC]: Change From Baseline in Anxiety and Depression Score Using GAD-7 at Month 6 and 12
Description
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.
Time Frame
Baseline (Day 1) and at Month 6 and 12
Title
[CAB + RPV LA]: Change From Baseline in Anxiety and Depression Score Using GAD-7 at Month 5 and 11
Description
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.
Time Frame
Baseline (Day 1) and at Month 5 and 11
Title
Percentage of Participants Providing Response to Single Item Bespoke Questions From Baseline to Day of Choice
Description
Bespoke single-item questions are developed by ViiV Healthcare to assess concepts such as stigma, feelings about diagnosis, low mood/excitement relating to treatment.
Time Frame
Baseline (Day 1) and Day of Choice (approximately 20 weeks)
Title
[CAB + RPV LA]: Percentage of Participants Providing Response to Single Item Bespoke Questions From Day of Choice to Month 5 and 11
Description
Bespoke single-item questions are developed by ViiV Healthcare to assess concepts such as stigma, feelings about diagnosis, low mood/excitement relating to treatment.
Time Frame
Day of Choice (approximately 20 weeks) up to Month 5 and 11
Title
[DTG/3TC]: Percentage of Participants Providing Response to Single Item Bespoke Questions From Day of Choice to Month 6 and 12
Description
Bespoke single-item questions are developed by ViiV Healthcare to assess concepts such as stigma, feelings about diagnosis, low mood/excitement relating to treatment.
Time Frame
Day of Choice (approximately 20 weeks) up to Month 6 and 12
Title
[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
Description
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.
Time Frame
Day of Choice (approximately 20 weeks) up to Month 5 and 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants having 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. Exclusion Criteria: 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). 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 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. Participants with 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 the Screening result; or, if known, in any historical 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Facility Information:
Facility Name
GSK Investigational Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Franco antoni Felizarta
Facility Name
GSK Investigational Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+442089904466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Frederick Cruickshank

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
IPD Sharing URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

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

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