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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03446573




Registration number
NCT03446573
Ethics application status
Date submitted
5/01/2018
Date registered
27/02/2018

Titles & IDs
Public title
Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)
Scientific title
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed
Secondary ID [1] 0 0
2015-004401-17
Secondary ID [2] 0 0
204862
Universal Trial Number (UTN)
Trial acronym
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
Description of intervention(s) / exposure
Treatment: Drugs - DTG + 3TC
Treatment: Drugs - TAF based regimen (TBR)

Experimental: DTG + 3TC 50 mg/300 mg - Participants will receive a single tablet of a two-drug regimen of DTG 50 mg + 3TC 300 mg once daily from Day 1 through Week 200 (Early and Late Switch Phase).

Active comparator: TAF based regimen (TBR) - Participants will continue their TBR from Day 1 to Week 148 (Early Switch Phase), and eligible participants will switch to DTG + 3TC once daily from Week 148 to 200 (Late Switch Phase).


Treatment: Drugs: DTG + 3TC
DTG+3TC is supplied as white, oval, film-coated, fixed dose combination tablet. The tablets will be available in packed high density polyethylene (HDPE) bottles with induction seals and child-resistant closures.

Treatment: Drugs: TAF based regimen (TBR)
Participants will continue to receive their TBR.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144
Timepoint [3] 0 0
Weeks 96 and 144
Secondary outcome [4] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144
Timepoint [5] 0 0
Weeks 96 and 144
Secondary outcome [6] 0 0
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Timepoint [6] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [7] 0 0
Change From Baseline in CD4+ Cell Count at Weeks 96 and 144
Timepoint [7] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [8] 0 0
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48
Timepoint [8] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [9] 0 0
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144
Timepoint [9] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [10] 0 0
Number of Participants With Disease Progression at Weeks 24 and 48
Timepoint [10] 0 0
At Weeks 24 and 48
Secondary outcome [11] 0 0
Number of Participants With Disease Progression at Weeks 96 and 144
Timepoint [11] 0 0
At Weeks 96 and 144
Secondary outcome [12] 0 0
Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48
Timepoint [12] 0 0
Up to Week 48
Secondary outcome [13] 0 0
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48
Timepoint [13] 0 0
Up to Week 48
Secondary outcome [14] 0 0
Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148
Timepoint [14] 0 0
Up to Week 148
Secondary outcome [15] 0 0
Number of Participants With AEs by Their Severity Grades: Up to Week 48
Timepoint [15] 0 0
Up to Week 48
Secondary outcome [16] 0 0
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48
Timepoint [16] 0 0
Up to Week 48
Secondary outcome [17] 0 0
Number of Participants With AEs by Their Severity Grades: Up to Week 144
Timepoint [17] 0 0
Up to Week 144
Secondary outcome [18] 0 0
Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48
Timepoint [18] 0 0
Up to Week 48
Secondary outcome [19] 0 0
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48
Timepoint [19] 0 0
Up to Week 48
Secondary outcome [20] 0 0
Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144
Timepoint [20] 0 0
Up to Week 144
Secondary outcome [21] 0 0
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48
Timepoint [21] 0 0
Up to Week 48
Secondary outcome [22] 0 0
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36
Timepoint [22] 0 0
Up to Week 36
Secondary outcome [23] 0 0
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144
Timepoint [23] 0 0
Up to Week 144
Secondary outcome [24] 0 0
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48
Timepoint [24] 0 0
Up to Week 48
Secondary outcome [25] 0 0
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36
Timepoint [25] 0 0
Up to Week 36
Secondary outcome [26] 0 0
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144
Timepoint [26] 0 0
Up to Week 144
Secondary outcome [27] 0 0
Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48
Timepoint [27] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [28] 0 0
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen
Timepoint [28] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [29] 0 0
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144
Timepoint [29] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [30] 0 0
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48
Timepoint [30] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [31] 0 0
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Timepoint [31] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [32] 0 0
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144
Timepoint [32] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [33] 0 0
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48
Timepoint [33] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [34] 0 0
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Timepoint [34] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [35] 0 0
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144
Timepoint [35] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [36] 0 0
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48
Timepoint [36] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [37] 0 0
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Timepoint [37] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [38] 0 0
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144
Timepoint [38] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [39] 0 0
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Timepoint [39] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [40] 0 0
Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Timepoint [40] 0 0
Baseline (Day 1) and at weeks 24 and 48
Secondary outcome [41] 0 0
Change From Baseline in Fasting Lipids at Weeks 96 and 144
Timepoint [41] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [42] 0 0
Number of Participants With Genotypic Resistance: Up to Week 48
Timepoint [42] 0 0
Up to Week 48
Secondary outcome [43] 0 0
Number of Participants With Genotypic Resistance: Up to Week 144
Timepoint [43] 0 0
Up to Week 144
Secondary outcome [44] 0 0
Number of Participants With Phenotypic Resistance: Up to Week 48
Timepoint [44] 0 0
Up to Week 48
Secondary outcome [45] 0 0
Number of Participants With Phenotypic Resistance: Up to Week 144
Timepoint [45] 0 0
Up to Week 144
Secondary outcome [46] 0 0
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48
Timepoint [46] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [47] 0 0
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48
Timepoint [47] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [48] 0 0
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144
Timepoint [48] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [49] 0 0
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48
Timepoint [49] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [50] 0 0
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Timepoint [50] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [51] 0 0
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144
Timepoint [51] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [52] 0 0
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48
Timepoint [52] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [53] 0 0
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Timepoint [53] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [54] 0 0
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144
Timepoint [54] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [55] 0 0
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48
Timepoint [55] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [56] 0 0
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Timepoint [56] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [57] 0 0
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144
Timepoint [57] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [58] 0 0
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48
Timepoint [58] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [59] 0 0
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Timepoint [59] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [60] 0 0
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144
Timepoint [60] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [61] 0 0
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48
Timepoint [61] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [62] 0 0
Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144
Timepoint [62] 0 0
Baseline (Day 1) and at Weeks 96 and 144
Secondary outcome [63] 0 0
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48
Timepoint [63] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [64] 0 0
Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144
Timepoint [64] 0 0
Baseline (Day 1) and at Weeks 96 and 144

Eligibility
Key inclusion criteria
* Participant must be able to understand and comply with protocol requirements, instructions, and restrictions;
* Participant must be likely to complete the study as planned;
* Participant must be considered an appropriate candidate for participation in an investigative clinical trial with medication (example no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country).
* Aged 18 years or older (or older where required by local regulatory agencies), at the time of signing the informed consent.
* HIV-1 infected men or women.
* Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening.
* Plasma HIV-1 RNA <50 c/mL at Screening.
* Must be on uninterrupted ART for at least 6 months prior to screening. Only the following regimens are allowed:

* Participant on a TAF-based regimen for at least 6 months as the initial regimen, or
* Participants who switched from a tenofovir disoproxil fumarate (TDF) first-regimen TAF, without any changes to the other drugs in their regimen, and have been on the TAF-based regimen for at least 3 months immediately prior to Screening i.e., the only switch made is from TDF to TAF. This switch must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for suspected or established treatment failure. A switch from a PI boosted with ritonavir to the same PI boosted with cobicistat is allowed (and vice versa).
* A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test at screen and a negative urine hCG test at randomization [a local serum hCG test at Randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization]), not lactating, and at least one of the following conditions applies:

a. Non-reproductive potential defined as:
* Pre-menopausal females with one of the following:

* Documented tubal ligation
* Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
* Hysterectomy
* Documented bilateral oophorectomy
* Post-menopausal 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 [refer to laboratory reference ranges for confirmatory levels]). 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 enrolment.

b. 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 and for at least 2 weeks after the last dose of study medication.
* The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. All participants participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol. Eligible participants or their legal guardians must sign a written informed consent form before any protocol-specified assessments are conducted.

Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
* Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/millimeter (mm)^3 are NOT exclusionary.
* Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
* Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* 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 antigen antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
* Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study, or anticipated need for HCV therapy based on interferon or for any drugs that have a potential for adverse drug-drug interactions with study treatment throughout the entire study period.
* Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.
* History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
* Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
* Participants who in the investigator's judgment, poses a significant suicidality risk.
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
* Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any systemic immune suppressant.
* Exposure to an experimental drug or experimental vaccine within either 28 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 the first dose of investigational product (IP).
* Use of any regimen consisting of single or dual ART.
* Any evidence of major nucleoside reverse transcriptase inhibitor (NRTI) mutation or presence of any major INSTI resistance-associated mutation in any available prior resistance genotype assay test result, if known, must be provided to ViiV after screening and before randomization for review by ViiV Virology.
* Any verified Grade 4 laboratory abnormality.
* Alanine aminotransferase (ALT) >=5 times (*) the upper limit of normal (ULN) or ALT >=3 * ULN and bilirubin >=1.5 * ULN (with >35 percent [%] direct bilirubin).
* Creatinine clearance of <50 milliliter (mL)/minute/1.73 meter^2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method.
* Within the 6 to 12 month window prior to Screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL.
* Within the 6 to 12 month window prior to Screening and after confirmed suppression to <50 c/mL, 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
* Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement >=50 c/mL.
* Any drug holiday during the 6 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
* Any history of switch to another 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 =400 c/mL.
* Participants enrolled in France (or in other countries as required by local regulations or Ethics Committee/Institutional Review Board [IRB]) who:

* Participated in any study using an investigational drug or vaccine during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study, or
* Participate simultaneously in another clinical study.

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
18/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2022
Sample size
Target
Accrual to date
Final
743
Recruitment in Australia
Recruitment state(s)
NSW,QLD,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 - Surry Hills
Recruitment hospital [4] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [5] 0 0
GSK Investigational Site - Fortitude Valley
Recruitment hospital [6] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [7] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [8] 0 0
GSK Investigational Site - North Fitzroy
Recruitment hospital [9] 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 - Surry Hills
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
4006 - Fortitude Valley
Recruitment postcode(s) [6] 0 0
3053 - Carlton
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3078 - North Fitzroy
Recruitment postcode(s) [9] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
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
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
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
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Belgium
State/province [20] 0 0
Antwerpen
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Brussel
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Canada
State/province [24] 0 0
Manitoba
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
France
State/province [27] 0 0
Bordeaux
Country [28] 0 0
France
State/province [28] 0 0
Marseille
Country [29] 0 0
France
State/province [29] 0 0
Nice
Country [30] 0 0
France
State/province [30] 0 0
Paris Cedex 13
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Tourcoing cedex
Country [33] 0 0
Germany
State/province [33] 0 0
Bayern
Country [34] 0 0
Germany
State/province [34] 0 0
Hessen
Country [35] 0 0
Germany
State/province [35] 0 0
Niedersachsen
Country [36] 0 0
Germany
State/province [36] 0 0
Nordrhein-Westfalen
Country [37] 0 0
Germany
State/province [37] 0 0
Berlin
Country [38] 0 0
Germany
State/province [38] 0 0
Hamburg
Country [39] 0 0
Germany
State/province [39] 0 0
München
Country [40] 0 0
Japan
State/province [40] 0 0
Aichi
Country [41] 0 0
Japan
State/province [41] 0 0
Chiba
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Netherlands
State/province [43] 0 0
Rotterdam
Country [44] 0 0
Spain
State/province [44] 0 0
Galicia
Country [45] 0 0
Spain
State/province [45] 0 0
Alcala de Henares
Country [46] 0 0
Spain
State/province [46] 0 0
Alicante
Country [47] 0 0
Spain
State/province [47] 0 0
Badalona
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Cartagena (Murcia)
Country [50] 0 0
Spain
State/province [50] 0 0
Elche
Country [51] 0 0
Spain
State/province [51] 0 0
Granada
Country [52] 0 0
Spain
State/province [52] 0 0
Granollers (Barcelona)
Country [53] 0 0
Spain
State/province [53] 0 0
Huelva
Country [54] 0 0
Spain
State/province [54] 0 0
L'Hospitalet de Llobregat
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
Marbella
Country [58] 0 0
Spain
State/province [58] 0 0
Mataró
Country [59] 0 0
Spain
State/province [59] 0 0
Murcia
Country [60] 0 0
Spain
State/province [60] 0 0
Málaga
Country [61] 0 0
Spain
State/province [61] 0 0
Santiago de Compostela
Country [62] 0 0
Spain
State/province [62] 0 0
Sevilla
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
Spain
State/province [64] 0 0
Vilajoyosa
Country [65] 0 0
Spain
State/province [65] 0 0
Zaragoza
Country [66] 0 0
United Kingdom
State/province [66] 0 0
West Midlands
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Birmingham
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Brighton
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Bristol
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Crumpsall, Manchester
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Liverpool
Country [72] 0 0
United Kingdom
State/province [72] 0 0
London

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
GlaxoSmithKline
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/NCT03446573