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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02422797




Registration number
NCT02422797
Ethics application status
Date submitted
9/04/2015
Date registered
21/04/2015

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-2)
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
2014-005148-16
Secondary ID [2] 0 0
201637
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: Participants receiving CAR - Participants will receive CAR from Day 1 to Week 52 (Early Switch Phase), and eligible participants will switch to DTG 50 milligrams (mg) + RPV 25 mg once daily from Week 52 to 148 (Late Switch Phase).

Experimental: Participants receiving DTG 50 mg + RPV 25 mg - Participants will receive DTG 50 mg + RPV 25 mg once daily from Day 1 through Week 148 (Early and Late Switch Phase).


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

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

Treatment: Drugs: CAR
CAR will include 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
Baseline (Day 1), 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 52
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
Baseline (Day 1) and Week 48
Secondary outcome [7] 0 0
Mean Change From Baseline in Cystatin C at Week 48
Timepoint [7] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [8] 0 0
Mean Change From Baseline in D-Dimer at Week 48
Timepoint [8] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [9] 0 0
Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48
Timepoint [9] 0 0
Baseline (Day 1) and 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
Baseline (Day 1) and 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
Baseline (Day 1) and Week 48
Secondary outcome [12] 0 0
Mean Change From Baseline in Urine Phosphate at Week 48
Timepoint [12] 0 0
Baseline (Day 1) and 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
Baseline (Day 1) and 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
Baseline (Day 1) and Week 48
Secondary outcome [15] 0 0
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Timepoint [15] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [16] 0 0
Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48
Timepoint [16] 0 0
Baseline (Day 1) and 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
Baseline (Day 1) and Week 48
Secondary outcome [18] 0 0
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Timepoint [18] 0 0
Baseline (Day 1), Weeks 24 and 48
Secondary outcome [19] 0 0
Number of Participants With Genotypic Resistance-Early Switch Phase
Timepoint [19] 0 0
Up to Week 48
Secondary outcome [20] 0 0
Number of Participants With Genotypic Resistance-DTG+RPV Early Switch Arm 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 Late Switch Arm Through Late Switch Phase
Timepoint [21] 0 0
Post-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 48
Secondary outcome [23] 0 0
Number of Participants With Phenotypic Resistance-DTG+RPV Early Switch 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 Late Switch 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 Early Switch 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 Late Switch 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 Weeks 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
Up to Week 48
Secondary outcome [29] 0 0
Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
Timepoint [29] 0 0
Baseline (Day 1) and 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
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
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
Baseline (Day 1), Weeks 24 and 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
Baseline (Day 1), Weeks 4, 24 and 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 Early Switch Group Through Early and Late Switch Phase
Timepoint [37] 0 0
Baseline (Day 1), Weeks 56, 76, 100 and 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 Late Switch Group Through Late Switch Phase
Timepoint [38] 0 0
LS Baseline (Week 48), Weeks 56, 76, 100 and 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
Baseline (Day 1), Weeks 4, 24 and 48
Secondary outcome [40] 0 0
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Timepoint [40] 0 0
Baseline (Day 1), Weeks 56, 76, 100 and 148
Secondary outcome [41] 0 0
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase
Timepoint [41] 0 0
LS Baseline (Week 48), Weeks 56, 76, 100 and 148

Eligibility
Key inclusion criteria
* Participants must be able to understand and comply with protocol requirements, instructions, and restrictions.
* Participants must be likely to complete the study as planned.
* Participants must be 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 >=18 years of age.
* Must be 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 be eligible to enter and participate in the study if she is 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 can 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 includes: 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 be 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 is 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 are not acceptable methods of contraception. Note: these contraceptive requirements do not apply to females of reproductive potential with same sex partners only, when this is their preferred and usual lifestyle. 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.
* Participants who are willing and able to understand requirements of study participation and provide signed and dated written informed consent prior to screening.
* For participants enrolled in France: participants 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
Exclusionary Criteria prior to screening or Day 1:

* Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current Antiretroviral therapy (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 are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
* Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions include 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 are excluded; participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb are excluded. Note: Participants positive for anti-HBc (negative HBsAg status) and positive for HBsAb are immune to HBV and are not 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 pose a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk;
* Any pre-existing physical or mental condition 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;
* 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 take oral medication;

Exclusionary Treatments prior to Screening or Day 1:

* Use of medications which are 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 are currently participating, or are anticipated to be selected to participate in any other interventional study, with the exception of the DEXA sub-study 202094, after randomization (NOTE: Participants who are already enrolled into another interventional study at time of screening may be eligible after consultation with the GlaxoSmithKline study team prior to randomization. Considerations include participant's ability to attend all visits on schedule, and possible drug and study procedure compatibility).
* 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 are unwilling or unable to switch to an alternate medication. Note: Any prohibited medications that decrease DTG or RPV concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to the first dose and any other prohibited medications should be discontinued for a minimum of two weeks or a minimum of three half-lives (whichever is longer) prior to the first dose.

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. Note: Any prior genotypic resistance testing is not required but if available it must be provided to GlaxoSmithKline, after screening and before randomization, to provide direct evidence of no pre-existing exclusionary resistance mutations. You must wait for the study virologists to confirm the lack of exclusionary resistance mutations, which will be provided before the screening window closes.
* Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. 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 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 >35% direct bilirubin).
* Corrected QT interval (QTc [Bazett]) >450 milliseconds or QTc (Bazett) >480 milliseconds for participants with bundle branch block. The QTc is 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
21/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2023
Sample size
Target
Accrual to date
Final
518
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst, Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Surry Hills
Recruitment hospital [3] 0 0
GSK Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst, Sydney
Recruitment postcode(s) [2] 0 0
2010 - Surry Hills
Recruitment postcode(s) [3] 0 0
2010 - Sydney
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
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Santa Fe
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Canada
State/province [16] 0 0
Saskatchewan
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Lyon cedex 04
Country [19] 0 0
France
State/province [19] 0 0
Marseille.
Country [20] 0 0
France
State/province [20] 0 0
Paris Cedex 20
Country [21] 0 0
France
State/province [21] 0 0
Saint Denis Cedex 01
Country [22] 0 0
France
State/province [22] 0 0
Tourcoing cedex
Country [23] 0 0
Germany
State/province [23] 0 0
Niedersachsen
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein-Westfalen
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Italy
State/province [26] 0 0
Lombardia
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Barnaul
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Krasnodar
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Saratov
Country [30] 0 0
Russian Federation
State/province [30] 0 0
St. Petersburg
Country [31] 0 0
Spain
State/province [31] 0 0
Asturias
Country [32] 0 0
Spain
State/province [32] 0 0
Alicante
Country [33] 0 0
Spain
State/province [33] 0 0
Badalona
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Cartagena (Murcia)
Country [36] 0 0
Spain
State/province [36] 0 0
La Coruña
Country [37] 0 0
Spain
State/province [37] 0 0
La Laguna (Santa Cruz De Tenerife)
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Murcia
Country [40] 0 0
Spain
State/province [40] 0 0
Móstoles, Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Santiago de Compostela
Country [42] 0 0
Spain
State/province [42] 0 0
Valencia
Country [43] 0 0
Taiwan
State/province [43] 0 0
Kaohsiung
Country [44] 0 0
Taiwan
State/province [44] 0 0
New Taipei
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taichung
Country [46] 0 0
United Kingdom
State/province [46] 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
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/NCT02422797