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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02831764




Registration number
NCT02831764
Ethics application status
Date submitted
8/07/2016
Date registered
13/07/2016

Titles & IDs
Public title
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)
Scientific title
A Phase III, Randomised, Double-blind, Multicentre, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults
Secondary ID [1] 0 0
2016-000459-28
Secondary ID [2] 0 0
205543
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection, Human Immunodeficiency Virus 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dolutegravir (DTG)
Treatment: Drugs - Lamivudine (3TC)
Treatment: Drugs - Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)

Experimental: DTG + 3TC (50 mg+300 mg - Eligible participants will receive one 50 mg tablet of DTG plus one overencapsulated 300 mg 3TC tablet orally once daily upto 96 weeks; thereafter will receive DTG plus 3TC tablet upto Week 148 and will continue to receive this schedule until (i) DTG and 3TC are both locally approved for use as part of a dual regimen, and the single entities of DTG and 3TC are available to patients (e.g. through public health services), or (ii) the DTG/3TC FDC tablet, if required by local regulations, is available, , or (iii) the participant no longer derives clinical benefit, or (iv) the participant meets a protocol defined reason for discontinuation, or (v) development of the DTG plus 3TC dual regimen is terminated.

Active comparator: DTG + TDF/FTC FDC (50 mg+300/200 mg) - Eligible participants will receive one 50 mg tablet of DTG plus one overencapsulated TDF/ FTC FDC (300/200 mg) tablet orally once daily upto 96 weeks; thereafter will receive DTG plus TDF/FTC FDC tablets upto Week 148 (open-label randomised phase).


Treatment: Drugs: Dolutegravir (DTG)
DTG is available as 50 mg white, round, biconvex, film coated tablet debossed on one side with 'SV 572' and on the other side with '50'. The tablets are packaged into high density polyethylene (HDPE) bottles with induction seals and child resistant closures. Each 45 ml bottle contains 30 tablets and a desiccant. DTG 50 mg tablet will be orally administered once daily with or without food upto 148 weeks.

Treatment: Drugs: Lamivudine (3TC)
Lamivudine is available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg lamivudine to visually match overencapsulated TDF/FTC FDC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated 3TC 300 mg tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets debossed with 'GX CJ7' on both sides, packed in over labelled HDPE bottles with child-resistant closures each containing 30 tablets.

Treatment: Drugs: Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
Tenofovir disoproxil fumarate and Emtricitabine are available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg TDF and 200 mg FTC to visually match overencapsulated 3TC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated tenofovir disoproxil fumarate/emtricitabine tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, tenofovir disoproxil fumarate/emtricitabine will be dispensed as 300/200 mg white, blue, capsule shaped, film coated tablets debossed with 'GILEAD' on one side and '701' on another side, packed in overlabelled HDPE bottles with polypropylene childresistant closures each containing 30 tablets and a desiccant.
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 Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) 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 at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
Timepoint [2] 0 0
Week 96
Secondary outcome [3] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
Timepoint [3] 0 0
Week 144
Secondary outcome [4] 0 0
Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
Timepoint [4] 0 0
Up to Week 144
Secondary outcome [5] 0 0
CD4+ Cell Counts at Weeks 24 and 48
Timepoint [5] 0 0
Weeks 24 and 48
Secondary outcome [6] 0 0
CD4+ Cell Counts at Week 96
Timepoint [6] 0 0
Week 96
Secondary outcome [7] 0 0
CD4+ Cell Counts at Week 144
Timepoint [7] 0 0
Week 144
Secondary outcome [8] 0 0
Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
Timepoint [8] 0 0
Baseline and Weeks 24, 48
Secondary outcome [9] 0 0
Changes From Baseline in CD4+ Cell Counts at Week 96
Timepoint [9] 0 0
Baseline and Week 96
Secondary outcome [10] 0 0
Changes From Baseline in CD4+ Cell Counts at Week 144
Timepoint [10] 0 0
Baseline and Week 144
Secondary outcome [11] 0 0
Number of Participants With HIV-1 Disease Progression up to Week 144
Timepoint [11] 0 0
Up to Week 144
Secondary outcome [12] 0 0
Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
Timepoint [12] 0 0
Up to Week 144
Secondary outcome [13] 0 0
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
Timepoint [13] 0 0
Up to Week 144
Secondary outcome [14] 0 0
Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148
Timepoint [14] 0 0
Up to Week 148
Secondary outcome [15] 0 0
Number of Participants With AEs by Maximum Severity Grades up to Week 148
Timepoint [15] 0 0
Up to Week 148
Secondary outcome [16] 0 0
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148
Timepoint [16] 0 0
Up to Week 148
Secondary outcome [17] 0 0
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
Timepoint [17] 0 0
Up to Week 144
Secondary outcome [18] 0 0
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
Timepoint [18] 0 0
Up to Week 144
Secondary outcome [19] 0 0
Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
Timepoint [19] 0 0
Up to Weeks 24, 48 and 96
Secondary outcome [20] 0 0
Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
Timepoint [20] 0 0
Up to Week 144
Secondary outcome [21] 0 0
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
Timepoint [21] 0 0
Baseline and at Weeks 24, 48
Secondary outcome [22] 0 0
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
Timepoint [22] 0 0
Baseline and at Week 96
Secondary outcome [23] 0 0
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
Timepoint [23] 0 0
Baseline and at Week 144
Secondary outcome [24] 0 0
Change From Baseline in Renal Biomarker-Serum RBP at Week 96
Timepoint [24] 0 0
Baseline and at Week 96
Secondary outcome [25] 0 0
Change From Baseline in Renal Biomarker-Serum RBP at Week 144
Timepoint [25] 0 0
Baseline and at Week 144
Secondary outcome [26] 0 0
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
Timepoint [26] 0 0
Baseline and at Weeks 24, 48
Secondary outcome [27] 0 0
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
Timepoint [27] 0 0
Baseline and at Week 96
Secondary outcome [28] 0 0
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
Timepoint [28] 0 0
Baseline and at Week 144
Secondary outcome [29] 0 0
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
Timepoint [29] 0 0
Baseline and at Weeks 24, 48
Secondary outcome [30] 0 0
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
Timepoint [30] 0 0
Baseline and at Week 96
Secondary outcome [31] 0 0
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
Timepoint [31] 0 0
Baseline and at Week 144
Secondary outcome [32] 0 0
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
Timepoint [32] 0 0
Baseline and Weeks 24, 48
Secondary outcome [33] 0 0
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
Timepoint [33] 0 0
Baseline and Week 96
Secondary outcome [34] 0 0
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
Timepoint [34] 0 0
Baseline and at Week 144
Secondary outcome [35] 0 0
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
Timepoint [35] 0 0
Baseline (Day 1) and at Weeks 24, 48
Secondary outcome [36] 0 0
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
Timepoint [36] 0 0
Baseline (Day 1) and at Week 96
Secondary outcome [37] 0 0
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
Timepoint [37] 0 0
Baseline (Day 1) and at Week 144
Secondary outcome [38] 0 0
Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
Timepoint [38] 0 0
Baseline and at Weeks 24, 48
Secondary outcome [39] 0 0
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
Timepoint [39] 0 0
Baseline and at Week 96
Secondary outcome [40] 0 0
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
Timepoint [40] 0 0
Baseline and at Week 144
Secondary outcome [41] 0 0
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
Timepoint [41] 0 0
Baseline and at Weeks 24, 48
Secondary outcome [42] 0 0
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
Timepoint [42] 0 0
Baseline (Day 1) and at Week 96
Secondary outcome [43] 0 0
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
Timepoint [43] 0 0
Baseline (Day 1) and at Week 144
Secondary outcome [44] 0 0
Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
Timepoint [44] 0 0
Baseline (Day 1) and at Weeks 24, 48
Secondary outcome [45] 0 0
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
Timepoint [45] 0 0
Baseline (Day 1) and at Week 96
Secondary outcome [46] 0 0
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
Timepoint [46] 0 0
Baseline (Day 1) and at Week 144
Secondary outcome [47] 0 0
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
Timepoint [47] 0 0
Weeks 24 and 48
Secondary outcome [48] 0 0
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
Timepoint [48] 0 0
Week 96
Secondary outcome [49] 0 0
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
Timepoint [49] 0 0
Week 144
Secondary outcome [50] 0 0
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
Timepoint [50] 0 0
Week 24
Secondary outcome [51] 0 0
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
Timepoint [51] 0 0
Week 48
Secondary outcome [52] 0 0
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
Timepoint [52] 0 0
Week 96
Secondary outcome [53] 0 0
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
Timepoint [53] 0 0
Week 144
Secondary outcome [54] 0 0
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
Timepoint [54] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [55] 0 0
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
Timepoint [55] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [56] 0 0
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
Timepoint [56] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [57] 0 0
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
Timepoint [57] 0 0
Baseline (Day 1) and Week 144
Secondary outcome [58] 0 0
Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
Timepoint [58] 0 0
Baseline (Day 1) and Weeks 4, 24, 48
Secondary outcome [59] 0 0
Change From Baseline in EQ-5D-5L Utility Score at Week 96
Timepoint [59] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [60] 0 0
Change From Baseline in EQ-5D-5L Utility Score at Week 144
Timepoint [60] 0 0
Baseline (Day 1) and Week 144
Secondary outcome [61] 0 0
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48
Timepoint [61] 0 0
Baseline (Day 1) and Weeks 4, 24, 48
Secondary outcome [62] 0 0
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
Timepoint [62] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [63] 0 0
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
Timepoint [63] 0 0
Baseline (Day 1) and Week 144

Eligibility
Key inclusion criteria
* Must be an HIV 1 infected adult >=18 years of age (or older, if required by local regulations) at the time of signing the informed consent
* An eligible female participant should not be pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at Screening and negative urine test at Baseline), not lactating, and at least one of the following conditions applies

* Non reproductive premenopausal women are those that have undergone documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow up confirmation of bilateral tubal occlusion or documented bilateral oophorectomy or hysterectomy
* Non reproductive premenopausal women are those with 12 months of spontaneous amenorrhea and >=45 years of age
* Women with reproductive potential agree to follow one of the protocol-defined methods for avoiding pregnancy
* Should have screening plasma HIV 1 RNA levels of 1000 c/mL to <=100,000 c/mL. If an independent review of accumulated data from other clinical trials investigating the DTG plus 3TC dual regimen is supportive of the DTG plus 3TC treatment regimen, enrolment will be opened to participants with Screening plasma HIV 1 RNA of 1000 c/mL to <=500,000 c/mL
* Participant should be antiretroviral naïve (defined as <=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection). Participants who received HIV post exposure prophylaxis (PEP) or pre exposure prophylaxis (PrEP) in the past are allowed as long as the last PEP/PrEP dose was >1 year from HIV diagnosis or there is documented HIV seronegativity between the last prophylactic dose and the date of HIV diagnosis
* Participants or the participants legal representative capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and the protocol
* Participants enrolled in France: a participant will be eligible for inclusion in this study only if either 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
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 (CDC, 2014), except cutaneous Kaposi's sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm^3
* 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 or HBV surface antibody (anti-HBs or HBsAb) based on:

Participants positive for HBV surface antigen (HBsAg) at screening will be excluded Participants negative for HBV core antibody (anti HBs) but positive for anti HBc (negative HBsAg status) and positive for HBV deoxyribose nucleic acid (DNA) will be excluded; however, participants positive for anti HBc (negative HBsAg status) and positive for anti HBs (past and/or current evidence) are immune to HBV and will not be excluded

* Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug:drug interactions with study treatment throughout the entire study period
* Untreated syphilis infection positive RPR at Screening without clear documentation of treatment. Participants who are at least 14 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; other localised malignancies require agreement between the investigator and the Study Medical Monitor for inclusion of the participant
* Participants who in the Investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behaviour and/or suicidal ideation may be considered as evidence of serious suicide 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
* Treatment with any agent, except recognised ART as allowed above, with documented activity against HIV 1 in vitro within 28 days of first dose of study treatment
* 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 study treatment
* Participants enrolled in France: the participant has participated in any study using an investigational drug 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 the participant will participate simultaneously in another clinical study
* Any evidence of pre existing viral resistance based on the presence of any major resistance associated mutation in the Screening result or, if known, in any historical resistance test result
* Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result
* Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participants participation in the study of an investigational compound
* Alanine aminotransferase (ALT) >=5 times the upper limit of normal (ULN) or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin)
* Creatinine clearance of <50 mL/min per 1.73 m^2 via the chronic kidney disease epidemiology collaboration (CKD EPI) method

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
18/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2022
Sample size
Target
Accrual to date
Final
722
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Parramatta
Recruitment hospital [3] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [4] 0 0
GSK Investigational Site - North Fitzroy
Recruitment hospital [5] 0 0
GSK Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
Prahran 3181 - Melbourne
Recruitment postcode(s) [4] 0 0
3068 - North Fitzroy
Recruitment postcode(s) [5] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Argentina
State/province [13] 0 0
Santa Fe
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autónoma de Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Belgium
State/province [17] 0 0
Bruxelles
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
State/province [19] 0 0
Lodelinsart
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
France
State/province [23] 0 0
Bobigny
Country [24] 0 0
France
State/province [24] 0 0
Lyon
Country [25] 0 0
France
State/province [25] 0 0
Paris Cedex 20
Country [26] 0 0
Germany
State/province [26] 0 0
Nordrhein-Westfalen
Country [27] 0 0
Germany
State/province [27] 0 0
Frankfurt/main
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
München
Country [30] 0 0
Italy
State/province [30] 0 0
Emilia-Romagna
Country [31] 0 0
Italy
State/province [31] 0 0
Liguria
Country [32] 0 0
Italy
State/province [32] 0 0
Lombardia
Country [33] 0 0
Italy
State/province [33] 0 0
Piemonte
Country [34] 0 0
Italy
State/province [34] 0 0
Bergamo
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Monza
Country [37] 0 0
Mexico
State/province [37] 0 0
Jalisco
Country [38] 0 0
Mexico
State/province [38] 0 0
Distrito Federal
Country [39] 0 0
Mexico
State/province [39] 0 0
Mexico
Country [40] 0 0
Peru
State/province [40] 0 0
Lima
Country [41] 0 0
Poland
State/province [41] 0 0
Bydgoszcz
Country [42] 0 0
Portugal
State/province [42] 0 0
Amadora
Country [43] 0 0
Portugal
State/province [43] 0 0
Lisboa
Country [44] 0 0
Portugal
State/province [44] 0 0
Porto
Country [45] 0 0
Romania
State/province [45] 0 0
Bucharest
Country [46] 0 0
Romania
State/province [46] 0 0
Bucuresti
Country [47] 0 0
Romania
State/province [47] 0 0
Iasi
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Izhevsk
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Kazan
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Kemerovo
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Krasnodar
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St. Petersburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
St.Peterburg
Country [54] 0 0
Spain
State/province [54] 0 0
Alcorcon
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Granada
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Malaga
Country [59] 0 0
Spain
State/province [59] 0 0
Marid
Country [60] 0 0
Spain
State/province [60] 0 0
Sevilla
Country [61] 0 0
Spain
State/province [61] 0 0
Valencia
Country [62] 0 0
Switzerland
State/province [62] 0 0
Bern
Country [63] 0 0
Switzerland
State/province [63] 0 0
Geneve
Country [64] 0 0
Switzerland
State/province [64] 0 0
Zuerich
Country [65] 0 0
Taiwan
State/province [65] 0 0
Kaohsiung
Country [66] 0 0
Taiwan
State/province [66] 0 0
New Taipei
Country [67] 0 0
Taiwan
State/province [67] 0 0
Tainan
Country [68] 0 0
Taiwan
State/province [68] 0 0
Taipei
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taoyuan
Country [70] 0 0
United Kingdom
State/province [70] 0 0
London
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Brighton
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Liverpool
Country [73] 0 0
United Kingdom
State/province [73] 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
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/NCT02831764