Clinical Trials

MainTitle

Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

This study is ongoing, but not recruiting participants.
Sponsor
ViiV Healthcare


Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02362503

First received: February 9, 2015
Last updated: July 29, 2019
Last Verified: July 2019
History of Changes
Purpose

Purpose

The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.

Condition Intervention Phase
HIV Infections

Drug : BMS-663068
Other : Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort [ Time Frame: Day 1 and Day 8 ]
    Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.
Secondary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort [ Time Frame: Day 1 and Day 8 ]
    The percentage of participants in the Randomized Cohort with HIV-1 RNA decreases from Day 1 that exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8 was determined by comparing HIV-1 RNA Day 1 measurement of each participant to their Day 8 measurement. This was an ITT analysis that classified participants without HIV-1 RNA at Day 1 or Day 8 as failures. The percentage of responders along with 95% confidence interval based on Wilson score is presented.
  • Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24 and 48-Randomized Cohort [ Time Frame: Weeks 24 and 48 ]
    The durability of response (that is, the number of participants achieving HIV-1 RNA <40 c/mL) at Weeks 24 and 48 of open-label fostemsavir plus OBT in the Randomized Cohort was assessed using the Food and Drug Administration (FDA) snapshot algorithm in which participants without HIV-1 RNA at Weeks 24 and 48 or those who changed OBT due to lack of efficacy through Weeks 24 and 48 were counted as failures. The percentage of participants in the Randomized Cohort who achieved virologic success (HIV-1 RNA <40 c/mL) at Weeks 24 and 48 is presented along with 95% Wilson confidence interval. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
  • Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort [ Time Frame: Up to Week 48 analysis cut-off date ]
    An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; an important medical event that may jeopardize the participant or require intervention. Number of participants with on-treatment SAEs and AEs leading to withdrawal of study treatment is presented. SAEs and AELDs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
  • Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort [ Time Frame: Baseline and up to Week 48 analysis cut-off date ]
    Laboratory toxicities were graded for severity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with clinical chemistry toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
  • Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort [ Time Frame: Baseline and up to Week 48 analysis cut-off date ]
    Laboratory toxicities were graded for severity according to the DAIDS grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with hematology toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
  • Number of Participants With Centers for Disease Control (CDC) Class C Events-Randomized Cohort [ Time Frame: Up to Week 48 analysis cut-off date ]
    Disease progression during open label fostemsavir plus OBT was assessed based on the occurrence of new AIDS defining events (CDC Class C events) or death. The number of participants with on-treatment CDC Class C AIDS events is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
  • Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count at Day 8-Randomized Cohort [ Time Frame: Day 1 and Day 8 ]
    CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell counts from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an in-dependent variable, and Day 1 CD4+ cell count as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (i.e., imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.
  • Change in CD4+ T- Cell Count Percentage From Day 1 at Day 8-Randomized Cohort [ Time Frame: Day 1 and Day 8 ]
    CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count percentage from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell count percentage from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 CD4+ cell count percentage as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (ie, imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.
  • Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 48-Randomized Cohort [ Time Frame: Baseline and up to Week 48 ]
    Blood samples were collected for the analysis of HIV-1 RNA. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
  • Change From Baseline in CD4+ T- Cell Count Through Week 48-Randomized Cohort [ Time Frame: Baseline and up to Week 48 ]
    CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
  • Change From Baseline in CD4+ T- Cell Count Percentage Through Week 48 [ Time Frame: Baseline and up to Week 48 ]
    CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
  • Number of Participants With Treatment-emergent Viral Genotypic Substitution of Interest in the GP160 Domain as a Measure of Genotypic Resistance-Randomized Cohort [ Time Frame: Week 48 ]
    Plasma samples were collected for drug resistance testing. Participants with emergent viral genotypic substitutions of interest in GP160 domain was identified by next-generation sequencing (NGS) assay. Virologic failure (VF) Population comprised of all participants with available phenotypic and genotypic resistance data meeting at the time protocol defined virologic failure (PDVF) was met. Criteria for PDVF was a) Confirmed, or last available prior to discontinuation, HIV-1 RNA >=400 c/mL at any time after prior confirmed suppression to <400 c/mL prior to Week 24 or Confirmed, or last available prior to discontinuation, >1 log10 c/mL increase in HIV-1 RNA at any time above nadir level where nadir is >=40 c/mL prior to Week 24. b) Confirmed, or last available prior to discontinuation, HIV-1 RNA >=400 c/mL at or after Week 24. All participants received fostemsavir during open-label period irrespective of original randomization; hence, combined totals for Randomized Cohort is presented.
  • Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort [ Time Frame: Week 48 ]
    The phenotypic resistance to a drug is defined in terms of a fold change (FC) in IC50s, ie, the ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of a reference strain (wild type control). FCR was calculated as FC at PDVF divided by Baseline FC. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. FCR<1 indicates that FC is smaller on-treatment than at Baseline. FCR >3 indicates that on-treatment FC is 3 times greater than it was at Baseline. All the participants received fostemsavir during open-label period irrespective of the original arms to which they were randomized; hence, combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.

Enrollment: 371
Study Start Date: February 23, 2015
Estimated Study Completion Date: December 31, 2024
Estimated Primary Completion Date: August 18, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: A1: BMS-663068
Phase 1: BMS-663068 600 mg tablets orally twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068

BMS-663068

Active Comparator: B1: Placebo + BMS-663068
Phase 1: Placebo twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068

BMS-663068

Other: Placebo

Placebo

Experimental: BMS-663068
BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068

BMS-663068

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Men and non-pregnant women with chronic HIV-1 infection
  • Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes
  • Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)
  • Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety
  • Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort
  • Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort


Exclusion Criteria:
  • Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
  • HIV-2 infection
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN
  • Alkaline Phosphatase > 5 x ULN
  • Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on
atazanavir and has predominantly unconjugated hyperbilirubinemia)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02362503

Locations

United States, California
GSK Investigational Site
Los Angeles, California, United States, 90008
GSK Investigational Site
Los Angeles, California, United States, 90027
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Los Angeles, California, United States, 90069
GSK Investigational Site
Palm Springs, California, United States, 92262
GSK Investigational Site
San Francisco, California, United States, 94115
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80262
United States, Connecticut
GSK Investigational Site
New Haven, Connecticut, United States, 06510
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
GSK Investigational Site
Washington, District of Columbia, United States, 20009
United States, Florida
GSK Investigational Site
Fort Pierce, Florida, United States, 34982
GSK Investigational Site
Oakland Park, Florida, United States, 33306
GSK Investigational Site
Orlando, Florida, United States, 32801
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Atlanta, Georgia, United States, 30312
GSK Investigational Site
Savannah, Georgia, United States, 31401
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Chicago, Illinois, United States, 60613
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
GSK Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 211
United States, Michigan
GSK Investigational Site
Southfield, Michigan, United States, 48075
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
GSK Investigational Site
Newark, New Jersey, United States, 07102
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10467
GSK Investigational Site
Manhasset, New York, United States, 11030
GSK Investigational Site
New York, New York, United States, 10010
GSK Investigational Site
New York, New York, United States, 10029
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45267-0405
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
GSK Investigational Site
Bellaire, Texas, United States, 77401
GSK Investigational Site
Dallas, Texas, United States, 75235
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Houston, Texas, United States, 77098
Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1405CKC
GSK Investigational Site
Cordoba, Córdova, Argentina, X5000JJS
GSK Investigational Site
Cordoba, Córdova, Argentina, X5000
GSK Investigational Site
Buenos Aires, Argentina, C1141ACG
GSK Investigational Site
Buenos Aires, Argentina, C1155ADP
GSK Investigational Site
Buenos Aires, Argentina, C1202ABB
GSK Investigational Site
Rosario, Argentina
Australia
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2000
GSK Investigational Site
Brussels, Belgium, 1000
Brazil
GSK Investigational Site
Curitiba, Paraná, Brazil, 80240-280
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
GSK Investigational Site
Campinas, São Paulo, Brazil, 13015-080
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 01416-901
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 04040-002
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 04121-000
GSK Investigational Site
Belo Horizonte, Brazil, 30130-100
GSK Investigational Site
Ribeirao Preto, Brazil, 14048-900
GSK Investigational Site
Rio de Janeiro, Brazil, 21040-900
GSK Investigational Site
Salvador, Brazil, 40110-060
Canada
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y8
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
GSK Investigational Site
Montreal, Quebec, Canada, H2L 5B1
GSK Investigational Site
Quebec, Canada, G1V 4G5
GSK Investigational Site
Vancouver, Canada, V6H3N1
Chile
GSK Investigational Site
Santiago Centro, Región Metro De Santiago, Chile, 8360159
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Santiago, Chile, 7500520
GSK Investigational Site
Santiago, Chile, 8330074
GSK Investigational Site
Temuco, Chile, 4781151
Colombia
GSK Investigational Site
Bogota, Colombia
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
Cali, Valle Del Cauca, Colombia, 760032
France
GSK Investigational Site
Bordeaux cedex, France, 33076
GSK Investigational Site
Marseille, France, 13009
GSK Investigational Site
Nantes, France, 44093
GSK Investigational Site
Paris Cedex 12, France, 75571
GSK Investigational Site
Paris, France, 75004
GSK Investigational Site
Paris, France, 75010
GSK Investigational Site
Paris, France, 75013
GSK Investigational Site
Paris, France, 75018
GSK Investigational Site
Paris, France, 75020
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Munchen, Bayern, Germany, 80336
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
GSK Investigational Site
Berlin, Germany, 10439
GSK Investigational Site
Berlin, Germany, 12157
GSK Investigational Site
Berlin, Germany, 13353
Greece
GSK Investigational Site
Athens, Greece, 16121
GSK Investigational Site
Thessaloniki, Greece, 54636
Ireland
GSK Investigational Site
Dublin, Ireland, Dublin 7
Italy
GSK Investigational Site
Roma, Lazio, Italy, 00149
GSK Investigational Site
Roma, Lazio, Italy, 00168
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Torino, Piemonte, Italy, 10149
GSK Investigational Site
Modena, Italy, 41124
GSK Investigational Site
Monza, Italy, 20900
Mexico
GSK Investigational Site
Ciudad de México, Estado De México, Mexico, 03100
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44280
GSK Investigational Site
Chihuahua, Mexico, 31000
GSK Investigational Site
Ciudad de Mexico, Mexico, 6700
GSK Investigational Site
Distrito Federal, Mexico, 06470
GSK Investigational Site
Distrito Federal, Mexico, 14000
Netherlands
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
Peru
GSK Investigational Site
Iquitos, Loreto, Peru, Iqui 01
GSK Investigational Site
Lima, Peru, 11
GSK Investigational Site
Lima, Peru, 14
GSK Investigational Site
Lima, Peru, 1
GSK Investigational Site
Lima, Peru, Lima 31
Poland
GSK Investigational Site
Szczecin, Poland, 70-376
GSK Investigational Site
Warszawa, Poland, 01-201
GSK Investigational Site
Wroclaw, Poland, 51-149
Portugal
GSK Investigational Site
Lisboa, Portugal, 1069-166
GSK Investigational Site
Lisbon, Portugal, 1649-035
Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico, 909
Romania
GSK Investigational Site
Bucharest, Romania, 021105
GSK Investigational Site
Bucharest, Romania, 72205
Russian Federation
GSK Investigational Site
Irkutsk, Russian Federation, 664035
GSK Investigational Site
Krasnodar, Russian Federation, 350015
South Africa
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6001
GSK Investigational Site
Bloemfontein, Free State, South Africa, 9301
GSK Investigational Site
Benoni, Gauteng, South Africa, 1500
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2092
GSK Investigational Site
Dundee, KwaZulu- Natal, South Africa, 3000
GSK Investigational Site
Observatory, Western Province, South Africa, 7925
GSK Investigational Site
Cape Town, South Africa, 7505
GSK Investigational Site
Durban, South Africa, 7925
Spain
GSK Investigational Site
Badalona, Barcelona, Spain, 8916
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Seville, Sevilla, Spain, 41014
Taiwan
GSK Investigational Site
Taipei, Taiwan, 10002
United Kingdom
GSK Investigational Site
Bournemouth, United Kingdom, BH7 7DW
GSK Investigational Site
Leicestershire, United Kingdom, LE1 5WW
GSK Investigational Site
London, United Kingdom, SW10 9NH

Sponsors and Collaborators

ViiV Healthcare

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02362503   History of Changes  
Other Study ID Numbers: 205888  
  AI438-047  
  2014-002111-41  
Study First Received: February 9, 2015  
Last Updated: July 29, 2019  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on August 19, 2019
This information is provided by ClinicalTrials.gov.