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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04542070




Registration number
NCT04542070
Ethics application status
Date submitted
1/09/2020
Date registered
9/09/2020

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed
Scientific title
A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed
Secondary ID [1] 0 0
213500
Universal Trial Number (UTN)
Trial acronym
SOLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Cabotegravir Tablets
Treatment: Drugs - Cabotegravir Injectable Suspension (CAB LA)
Treatment: Drugs - Rilpivirine Tablets
Treatment: Drugs - Rilpivirine Injectable Suspension (RPV LA)
Treatment: Drugs - BIKTARVY Tablets (BIK)

Active comparator: Biktarvy (BIK) - Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).

Experimental: Oral lead-in phase (OLI) - Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase

Experimental: Direct to injections (D2I) - Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.

Active comparator: Switch Q2M Group - Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.


Treatment: Drugs: Cabotegravir Tablets
CAB tablets were available as film coated tablets for oral administration.

Treatment: Drugs: Cabotegravir Injectable Suspension (CAB LA)
CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.

Treatment: Drugs: Rilpivirine Tablets
RPV was administered as tablets for oral administration.

Treatment: Drugs: Rilpivirine Injectable Suspension (RPV LA)
RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.

Treatment: Drugs: BIKTARVY Tablets (BIK)
BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population
Timepoint [1] 0 0
At month 12/11
Primary outcome [2] 0 0
Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population
Timepoint [2] 0 0
At month 12/11
Secondary outcome [1] 0 0
Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population
Timepoint [1] 0 0
At month 12/11
Secondary outcome [2] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population
Timepoint [2] 0 0
At month 12/11
Secondary outcome [3] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population
Timepoint [3] 0 0
At month 6/5
Secondary outcome [4] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population
Timepoint [4] 0 0
At month 6/5
Secondary outcome [5] 0 0
Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11
Timepoint [5] 0 0
Up to month 12
Secondary outcome [6] 0 0
Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5
Timepoint [6] 0 0
At month 6/5
Secondary outcome [7] 0 0
Absolute Values of HIV Viral Load
Timepoint [7] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [8] 0 0
Change From Baseline in HIV Viral Load
Timepoint [8] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [9] 0 0
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count
Timepoint [9] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [10] 0 0
Change From Baseline in CD4+ Cell Count
Timepoint [10] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [11] 0 0
Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11
Timepoint [11] 0 0
Up to Month 12/11
Secondary outcome [12] 0 0
Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5
Timepoint [12] 0 0
Up to Month 6/5
Secondary outcome [13] 0 0
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11
Timepoint [13] 0 0
Up to Month 12/11
Secondary outcome [14] 0 0
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5
Timepoint [14] 0 0
Up to Month 6/5
Secondary outcome [15] 0 0
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L))
Timepoint [15] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [16] 0 0
Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L))
Timepoint [16] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [17] 0 0
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L])
Timepoint [17] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [18] 0 0
Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L))
Timepoint [18] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [19] 0 0
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L))
Timepoint [19] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [20] 0 0
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol))
Timepoint [20] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [21] 0 0
Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol))
Timepoint [21] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [22] 0 0
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11
Timepoint [22] 0 0
Baseline (Day 1) and at Month 12/11
Secondary outcome [23] 0 0
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5
Timepoint [23] 0 0
Baseline (Day 1) and at month 6/5
Secondary outcome [24] 0 0
Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR)
Timepoint [24] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [25] 0 0
Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M
Timepoint [25] 0 0
Up to month 12/11
Secondary outcome [26] 0 0
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
Timepoint [26] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [27] 0 0
Change From Baseline in Individual Item Scores Using HIVTSQs
Timepoint [27] 0 0
Baseline (Day 1) and up to Month 12
Secondary outcome [28] 0 0
HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11
Timepoint [28] 0 0
At Month 12/11
Secondary outcome [29] 0 0
Individual Item Scores of HIVTSQc at Month 12/11
Timepoint [29] 0 0
At Month 12/11
Secondary outcome [30] 0 0
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M
Timepoint [30] 0 0
From Month 2/1 up to Month 12
Secondary outcome [31] 0 0
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M
Timepoint [31] 0 0
From Month 2/1 up to Month 12

Eligibility
Key inclusion criteria
* Participants aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent.
* A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies.

1. Non-reproductive potential defined as:

* Pre-menopausal females with one of the following:

1. Documented tubal ligation.
2. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion.
3. Hysterectomy.
4. Documented Bilateral Oophorectomy
* Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), 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.
* Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. BIK must be the participant's first or second regimen. If BIK is the second regimen, the first regimen must be an integrase inhibitor (INI) regimen. Only a single prior Integrase inhibitor (INI) regimen is allowed if BIK is a second line regimen >=6 months prior to screening. Any history of non-integrase strand transfer inhibitor regimens (that is. non-nucleoside reverse transcriptase inhibitor, protease inhibitor, C-C chemokine receptor 5 and other entry inhibitors) are not permitted. Any prior change in regimen, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for treatment failure (HIV-1 RNA >=400 c/mL).

The following are limited exceptions:

* A change from Tenofovir disoproxil fumarate (TDF) to TAF will not be considered a regimen change.
* Historical perinatal use of Nucleoside reverse transcriptase inhibitor (NRTI) when given in addition to an ongoing Highly active antiretroviral therapy (HAART) will not be considered a change in ART therapy regimen.
* The past use of ARVs in the context of Post Exposure Prophylaxis (PEP) or Pre-Exposure Prophylaxis (PrEP) while the participant was HIV negative will be allowed. Such cases will be evaluated on a case by case basis with the Medical Monitor, and may require documentation of HIV negative serology during time of PEP or PrEP.
* A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy.
* A change in formulation from multiple class regimens to single treatment regimens (of the same medications) would not be considered a change in ART regimen.

* Documented evidence of plasma HIV-1 RNA measurements <50 c/mL in the 6 months prior to Screening.
* Plasma HIV-1 RNA <50 c/mL at Screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >=50 c/mL.
* Within the 6 to 12-month window prior to Screening, documented evidence of any plasma HIV-1 RNA measurement greater than (>)200 c/mL, or 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
* History of prior treatment failure to any Department of Health and Human Services (DHHS) recommended ART regimen.
* History of drug holiday >1 month for any reason prior to Screening visit, except where all ART was stopped due to tolerability and/or safety concerns.
* Any change to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement >=200 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen).
* Participants who are currently participating in or anticipate being selected for any other interventional study.
* Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
* Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts <200 cells/microliter are not exclusionary.
* Participants with moderate to severe hepatic impairment.
* 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.
* 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.
* All participants will be screened for syphilis.

* Participants with untreated secondary (late latent) or tertiary syphilis infection, defined as a positive rapid plasma reagin (RPR) and a positive treponemal test 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 with primary syphilis or early latent secondary syphilis (acquired within the preceding year) who have a positive RPR test and have not been treated may be treated during the screening period and if completion of antibiotic treatment occurs during the screening period, may be allowed entry after consultation with the Medical Monitor. If antibiotic treatment cannot be completed before the screening window ends, participants may be rescreened once following completion of antibiotic therapy for primary or early latent secondary syphilis.
* 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.
* The participant has a tattoo, gluteal implant/enhancements or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
* 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), Hepatitis B surface antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows:

1. Participants positive for HBsAg are excluded.
2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded.
* Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who require or qualify for immediate HCV treatment are excluded for those co-infected participants who post entry into Switch Onto Long Acting Regimen (SOLAR) decide treatment for HCV infection is warranted or desired either by the participant or by the treating physician.

Participants with HCV co-infection will be allowed entry into this study if:

1. Liver enzymes meet entry criteria
2. HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the Month 14 visit. Additional information (where available) 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.
3. In the event that recent biopsy or imaging data is not available or inconclusive, the fibrosis (Fib)-4 score will be used to verify eligibility

i. Fib-4 score >3.25 is exclusionary ii. Fib-4 scores 1.45-3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: d. Age x aspartate aminotransferase (AST)/ Platelets x (square [Alanine aminotransferase {ALT}]).

* 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 [for example {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).
* History of liver cirrhosis with or without hepatitis viral co-infection.
* Ongoing or clinically relevant pancreatitis
* Clinically significant cardiovascular disease, as defined by history/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.
* 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 Study medical monitor for inclusion of the participant prior to randomization.
* 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.
* History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
* Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 milligram) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
* Corrected QT interval (QTc [Bazett]) >450 milliseconds (msec) or QTc (Bazett) >480 msec for participants with bundle branch block.
* Known or suspected active Coronavirus Disease-2019 (COVID-19) infection or has had contact with an individual with known COVID-19, within 14 days of study enrollment.
* Known or suspected presence of resistance mutations as defined by the International Antiviral Society-United States of America (IAS-USA) resistance guidelines to the individual components of BIK (BIC, FTC, TAF), RPV, and CAB by any historical resistance test result.
* Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.
* Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
* Participant has estimated creatine clearance <30mL/minute per 1.73 meter square (m^2) via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method.
* ALT >=3 times upper limit of normal (ULN).
* 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 Day 1 of this study.
* 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;
* 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, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of study Day 1. Treatment with acyclovir/valacyclovir is permitted.
* Use of medications which are associated with Torsade de Pointes.
* Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/04/2023
Sample size
Target
Accrual to date
Final
687
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst, Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [4] 0 0
GSK Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst, Sydney
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Austria
State/province [20] 0 0
Innsbruck
Country [21] 0 0
Austria
State/province [21] 0 0
Linz
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
Country [23] 0 0
Belgium
State/province [23] 0 0
Hasselt
Country [24] 0 0
Belgium
State/province [24] 0 0
Leuven
Country [25] 0 0
Belgium
State/province [25] 0 0
Liege
Country [26] 0 0
Belgium
State/province [26] 0 0
Lodelinsart
Country [27] 0 0
Canada
State/province [27] 0 0
Manitoba
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Saskatchewan
Country [31] 0 0
France
State/province [31] 0 0
Bobigny
Country [32] 0 0
France
State/province [32] 0 0
Bordeaux Cedex
Country [33] 0 0
France
State/province [33] 0 0
Clermont-Ferrand
Country [34] 0 0
France
State/province [34] 0 0
Créteil
Country [35] 0 0
France
State/province [35] 0 0
Le Kremlin-Bicetre Cedex
Country [36] 0 0
France
State/province [36] 0 0
Nantes
Country [37] 0 0
France
State/province [37] 0 0
Nice cedex 3
Country [38] 0 0
France
State/province [38] 0 0
Tourcoing cedex
Country [39] 0 0
Germany
State/province [39] 0 0
Bayern
Country [40] 0 0
Germany
State/province [40] 0 0
Nordrhein-Westfalen
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Ireland
State/province [43] 0 0
Dublin
Country [44] 0 0
Italy
State/province [44] 0 0
Emilia-Romagna
Country [45] 0 0
Italy
State/province [45] 0 0
Lazio
Country [46] 0 0
Italy
State/province [46] 0 0
Lombardia
Country [47] 0 0
Italy
State/province [47] 0 0
Piemonte
Country [48] 0 0
Japan
State/province [48] 0 0
Aichi
Country [49] 0 0
Japan
State/province [49] 0 0
Osaka
Country [50] 0 0
Japan
State/province [50] 0 0
Tokyo
Country [51] 0 0
Netherlands
State/province [51] 0 0
Amsterdam
Country [52] 0 0
Spain
State/province [52] 0 0
Alcala de Henares
Country [53] 0 0
Spain
State/province [53] 0 0
Burgos
Country [54] 0 0
Spain
State/province [54] 0 0
Huelva
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Majadahonda( Madrid
Country [57] 0 0
Spain
State/province [57] 0 0
Sant Boi de Llobregat
Country [58] 0 0
Spain
State/province [58] 0 0
Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Switzerland
State/province [60] 0 0
Bern
Country [61] 0 0
Switzerland
State/province [61] 0 0
Geneve
Country [62] 0 0
Switzerland
State/province [62] 0 0
Lausanne
Country [63] 0 0
Switzerland
State/province [63] 0 0
Zuerich
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Merseyside
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Glasgow
Country [66] 0 0
United Kingdom
State/province [66] 0 0
London
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ViiV Healthcare
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen, LP
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
ViiV Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Anonymized IPD is 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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04542070