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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02429791




Registration number
NCT02429791
Ethics application status
Date submitted
9/04/2015
Date registered
29/04/2015

Titles & IDs
Public title
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)
Scientific title
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults Who Are Virologically Suppressed
Secondary ID [1] 0 0
2014-005147-40
Secondary ID [2] 0 0
201636
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 50 mg
Treatment: Drugs - RPV 25 mg
Treatment: Drugs - CAR

Active comparator: Current antiretroviral regimen (CAR) - Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Experimental: DTG + RPV - Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).


Treatment: Drugs: DTG 50 mg
Participants received one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid.

Treatment: Drugs: RPV 25 mg
Participants received one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet contained 27.5 mg of rilpivirine hydrochloride, which was equivalent to 25 mg of RPV.

Treatment: Drugs: CAR
CAR included the following combinations: 2 NRTIs + 1 INI, 2 NRTIs + 1 NNRTI, or 2 NRTIs + 1 PI
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Timepoint [1] 0 0
At Weeks 24 and 48
Secondary outcome [2] 0 0
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Timepoint [3] 0 0
Up to Week 411 or study discontinuation
Secondary outcome [4] 0 0
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Timepoint [4] 0 0
Up to 48 weeks
Secondary outcome [5] 0 0
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks
Timepoint [5] 0 0
Up to 48 weeks
Secondary outcome [6] 0 0
Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48
Timepoint [6] 0 0
At Week 48
Secondary outcome [7] 0 0
Mean Change From Baseline in Cystatin C at Week 48
Timepoint [7] 0 0
At Week 48
Secondary outcome [8] 0 0
Mean Change From Baseline in D-Dimer at Week 48
Timepoint [8] 0 0
At Week 48
Secondary outcome [9] 0 0
Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48
Timepoint [9] 0 0
At Week 48
Secondary outcome [10] 0 0
Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
Timepoint [10] 0 0
At Week 48
Secondary outcome [11] 0 0
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
Timepoint [11] 0 0
At Week 48
Secondary outcome [12] 0 0
Mean Change From Baseline in Urine Phosphate at Week 48
Timepoint [12] 0 0
At Week 48
Secondary outcome [13] 0 0
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Timepoint [13] 0 0
At Week 48
Secondary outcome [14] 0 0
Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
Timepoint [14] 0 0
At Week 48
Secondary outcome [15] 0 0
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Timepoint [15] 0 0
At Week 48
Secondary outcome [16] 0 0
Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48
Timepoint [16] 0 0
At Week 48
Secondary outcome [17] 0 0
Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48
Timepoint [17] 0 0
At Week 48
Secondary outcome [18] 0 0
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Timepoint [18] 0 0
At Week 24 and at Week 48
Secondary outcome [19] 0 0
Number of Participants With Genotypic Resistance- Early Switch Phase
Timepoint [19] 0 0
Up to Week 52
Secondary outcome [20] 0 0
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
Timepoint [20] 0 0
Up to Week 148
Secondary outcome [21] 0 0
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
Timepoint [21] 0 0
Post-Late switch (LS) Baseline (Week 52) up to Week 148
Secondary outcome [22] 0 0
Number of Participants With Phenotypic Resistance-Early Switch Phase
Timepoint [22] 0 0
Up to Week 52
Secondary outcome [23] 0 0
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
Timepoint [23] 0 0
Up to Week 148
Secondary outcome [24] 0 0
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
Timepoint [24] 0 0
Post-LS Baseline (Week 52) up to Week 148
Secondary outcome [25] 0 0
Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase
Timepoint [25] 0 0
Pre-dose at Week 4, 24, 48, 56, 76 and 100
Secondary outcome [26] 0 0
Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch Phase
Timepoint [26] 0 0
Pre-dose at Weeks 56, 76 and 100
Secondary outcome [27] 0 0
Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Timepoint [27] 0 0
Pre-dose at Week 2, 4 and 8
Secondary outcome [28] 0 0
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
Timepoint [28] 0 0
Week 48
Secondary outcome [29] 0 0
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
Timepoint [29] 0 0
At Week 48
Secondary outcome [30] 0 0
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Timepoint [30] 0 0
Up to 48 weeks
Secondary outcome [31] 0 0
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
Timepoint [31] 0 0
Up to 48 weeks
Secondary outcome [32] 0 0
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
Timepoint [32] 0 0
Up to 48 weeks
Secondary outcome [33] 0 0
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class
Timepoint [33] 0 0
Up to Week 48
Secondary outcome [34] 0 0
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class
Timepoint [34] 0 0
Up to Week 48
Secondary outcome [35] 0 0
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Timepoint [35] 0 0
At Week 24 and at Week 48
Secondary outcome [36] 0 0
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Timepoint [36] 0 0
At Week 4, Week 24 and Week 48
Secondary outcome [37] 0 0
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Timepoint [37] 0 0
At Week 56, Week 76, Week 100 and Week 148
Secondary outcome [38] 0 0
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Timepoint [38] 0 0
At Week 56, Week 76, Week 100 and Week 148
Secondary outcome [39] 0 0
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
Timepoint [39] 0 0
At Week 4, Week 24 and Week 48
Secondary outcome [40] 0 0
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Timepoint [40] 0 0
At Week 56, Week 76, Week 100 and Week 148
Secondary outcome [41] 0 0
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Timepoint [41] 0 0
At Week 56, Week 76, Week 100 and Week 148
Secondary outcome [42] 0 0
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
Timepoint [42] 0 0
Up to Week 411
Secondary outcome [43] 0 0
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
Timepoint [43] 0 0
Up to Week 411
Secondary outcome [44] 0 0
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
Timepoint [44] 0 0
Week 52 to Week 411
Secondary outcome [45] 0 0
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
Timepoint [45] 0 0
Week 52 to Week 411
Secondary outcome [46] 0 0
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
Timepoint [46] 0 0
Up to Week 411
Secondary outcome [47] 0 0
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
Timepoint [47] 0 0
Up to Week 411
Secondary outcome [48] 0 0
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
Timepoint [48] 0 0
Week 52 to Week 411
Secondary outcome [49] 0 0
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
Timepoint [49] 0 0
Week 52 to Week 411

Eligibility
Key inclusion criteria
* Participants must have been able to understand and comply with protocol requirements, instructions, and restrictions.
* Participants must have been likely to complete the study as planned.
* Participants must have been considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country, etc.).
* HIV-1 infected men or women of greater than or equal to (>=)18 years of age.
* Must have been on uninterrupted current regimen (either the initial or second combination antiretroviral therapy [cART] regimen) for at least 6 months prior to screening; Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification. Acceptable stable cART regimens prior to screening include 2 NRTIs plus INI (either the initial or second cART regimen), or an NNRTI (either the initial or second cART regimen), or a Boosted PI (or atazanavir unboosted) (either the initial or second PI-based cART regimen).
* 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;
* A female may have been eligible to enter and participate in the study if she was of : Non-child-bearing potential either defined as post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, Child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: Complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 2 weeks after discontinuation of all study medications and completion of the Follow-up visit; Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion); Male partner sterilization with documentation of azoospermia prior to the female participant's entry into the study and this male is the sole partner for that participant; The documentation on male sterility could come from the site personnel's review of participant's medical records, medical examination, and/or semen analysis, or medical history interview provided by her or her partner; Approved hormonal contraception for participants randomly assigned to DTG + RPV arm (and for participants randomly assigned to CAR following switch to DTG + RPV at Week 52) or approved hormonal contraception plus a barrier method for participants assigned to CAR through Week 52; Approved hormonal contraception included: Combined estrogen and progestogen oral contraceptive, Contraceptive subdermal implant, Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches. Any other method with published data showing that the expected failure rate is <1% per year. Any contraception method must have been used consistently, in accordance with the approved product label during treatment with study drug and for at least 2 weeks after discontinuation of study drug and completion of the Follow-Up Visit. The investigator was responsible for ensuring that participants understand how to properly use these methods of contraception. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception.
* Participants who were willing and able to understand requirements of study participation and provided signed and dated written informed consent prior to screening.
* For participants enrolled in France: participants were 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
Exclusionary Criteria prior to screening or Day 1:

* 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.
* 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.
* Any drug holiday during the window between initiating first HIV ART and 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 switch 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 >=400 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen).

Exclusionary medical conditions:

* Women who were pregnant, breastfeeding or planned to become pregnant or breastfeed during the study.
* Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions included cutaneous Kaposi's sarcoma not requiring systemic therapy and historic CD4+ lymphocyte counts of <200 cells per cubic millimeter (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 any of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, 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), and Hepatitis B surface antibody (HBsAb) as follows: Participants positive for HBsAg were excluded; Participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb were excluded.
* Participants with an anticipated need for any Hepatitis C virus (HCV) therapy during the Early Switch Phase and for interferon-based therapy for HCV throughout the entire study period.
* History or presence of allergy 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 intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization;
* Participants who in the investigator's judgment posed a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should have been considered when evaluating for suicide risk;
* Any pre-existing physical or mental condition which, in the opinion of the Investigator, could have interfered with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which could have compromised the safety of the participants;
* Any condition which, in the opinion of the Investigator, could have interfered with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication;

Exclusionary Treatments prior to Screening or Day 1:

* Use of medications which were associated with Torsades de Pointes.
* 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 immunomodulators that alter immune responses.
* 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 Day 1 of this study.
* Participants who were participating or anticipated to be selected to participate in any other interventional study, with the exception of the DEXA sub-study 202094, after randomization
* A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART.
* Current or prior history of etravirine (ETR) use.
* Current use of tipranavir/ritonavir or fosamprenavir/ritonavir.
* Participants receiving any prohibited medication and who were unwilling or unable to switch to an alternate medication.

Exclusionary Laboratory Values or Clinical Assessments at Screening:

* Evidence of viral resistance based on the presence of any resistance associated major PI, INI, NRTI, or NNRTI mutation and integrase (IN) resistance associated substitution R263K in any available prior resistance genotype assay results.
* Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test was 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 participant's participation in the study of an investigational compound.
* Alanine aminotransferase (ALT) >=5 × upper limit of normal (ULN), or ALT >=3 × ULN and bilirubin >=1.5 × ULN (with greater than [>] 35% direct bilirubin).
* Corrected QT interval (QTc [Bazett]) >450 milliseconds or QTc (Bazett) >480 milliseconds for participants with bundle branch block. The QTc was the QT interval corrected for heart rate according to Bazett's formula (QTcB).

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
14/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2023
Sample size
Target
Accrual to date
Final
510
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 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
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad Autonoma de Buenos Aire
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Liege
Country [14] 0 0
Canada
State/province [14] 0 0
Ottawa
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec City
Country [16] 0 0
Canada
State/province [16] 0 0
Toronto
Country [17] 0 0
Canada
State/province [17] 0 0
Vancouver
Country [18] 0 0
Canada
State/province [18] 0 0
Victoria
Country [19] 0 0
France
State/province [19] 0 0
Garches
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
Germany
State/province [22] 0 0
Frankfurt
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Muenchen
Country [25] 0 0
Italy
State/province [25] 0 0
Brescia
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Netherlands
State/province [27] 0 0
Rotterdam
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Kazan
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Orel
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Smolensk
Country [32] 0 0
Russian Federation
State/province [32] 0 0
St Petersburg
Country [33] 0 0
Spain
State/province [33] 0 0
Alcala de Henares
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Elche
Country [36] 0 0
Spain
State/province [36] 0 0
Granada
Country [37] 0 0
Spain
State/province [37] 0 0
Huelva
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Malaga
Country [40] 0 0
Spain
State/province [40] 0 0
Marbella
Country [41] 0 0
Spain
State/province [41] 0 0
Palma de Mallorca
Country [42] 0 0
Spain
State/province [42] 0 0
Sevilla
Country [43] 0 0
Spain
State/province [43] 0 0
Valencia
Country [44] 0 0
Taiwan
State/province [44] 0 0
Kaohsiung
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London
Country [47] 0 0
United Kingdom
State/province [47] 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 Pharmaceuticals
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
GlaxoSmithKline
Address [2] 0 0
Country [2] 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?
IPD for this study will be made available via the Clinical Study Data Request site.

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)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02429791