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A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. (VIKING-3)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01328041
First received: March 31, 2011
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus
Drug: dolutegravir
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 [ Time Frame: Baseline and Day 8 ] [ Designated as safety issue: No ]
    Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.

  • Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The number of participants who had viral load <50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.

  • Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) [ Time Frame: From the day of the first dose of study drug until study medication discontinuation or Week 48 analysis data cut-off (median of 507 study days) ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.

  • Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale [ Time Frame: From the day of the first dose of study drug until study medication discontinuation or Week 48 analysis data cut-off (median of 507 study days) ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to the DAIDS grading scale. The DAIDS displays events as Grades 1-4 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, potentially life threatening.

  • Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade [ Time Frame: From the day of the first dose of study drug until study medication discontinuation or Week 48 analysis data cut-off (median of 507 study days) ] [ Designated as safety issue: No ]
    The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.

  • Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade [ Time Frame: From the day of the first dose of study drug until study medication discontinuation or Week 48 analysis data cut-off (median of 507 study days) ] [ Designated as safety issue: No ]
    The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.


Secondary Outcome Measures:
  • Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The number of participants who had viral load <50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.

  • Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 [ Time Frame: Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL was assessed at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48.

  • Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 [ Time Frame: Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

  • Absolute Values for CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Weeks 4, 12, 24, and 48 [ Time Frame: Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Absolute values for CD4+ cell counts were assessed at Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Weeks 4, 12, 24, and 48.

  • Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and in CD8+ Cell Counts at Weeks 4, 12, 24, and 48 [ Time Frame: Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48, and median change from Baseline in CD8+ cell counts was assessed at Weeks 4, 12, 24, and 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

  • Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48 [ Time Frame: Baseline; Weeks 4, 12, 24, and 48 ] [ Designated as safety issue: No ]
    The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.

  • Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death) [ Time Frame: From Baseline to Week 48 ] [ Designated as safety issue: No ]
    The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).

  • Cmax and Ctau of DTG [ Time Frame: Day 8, Week 4, and Week 24 ] [ Designated as safety issue: No ]
    The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.

  • AUC(0-tau) and AUC(0-24) of DTG [ Time Frame: Day 8, Week 4, and Week 24 ] [ Designated as safety issue: No ]
    The area under the time concentration curve over the dosing interval (AUC[0-tau]) and from 0 to 24 hours (AUC[0-24]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.

  • C0 Assessment of DTG [ Time Frame: Day 8, Week 4, and Week 24 ] [ Designated as safety issue: No ]
    The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.

  • Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance [ Time Frame: From the start of study treatment to date cut-off (median of 507 study days) ] [ Designated as safety issue: No ]
    An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is a <0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of <1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 c/mL and confirmed plasma HIV-1 RNA levels >=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL and confirmed plasma HIV-1 RNA levels >1 log10 c/mL above the nadir value [nadir: >=400 c/mL]).

  • Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance [ Time Frame: From the start of study treatment to data cut-off (median of 507 study days) ] [ Designated as safety issue: No ]
    The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined as a <0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 copies/mL. PDVF after Day 8 was defined for virological non-respones (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 copies/mL and confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL and confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL).


Enrollment: 183
Study Start Date: May 2011
Estimated Study Completion Date: January 2016
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dolutegravir
dolutegravir plus background antiretroviral therapy optimised at Day 8
Drug: dolutegravir
50 mg twice daily

Detailed Description:

ING112574 is a Phase 3, multicentre, open-label, single arm study to assess the antiviral activity and safety of DTG containing regimen in HIV-1 infected ART-experienced adults with historical or current evidence of resistance to RAL or ELV. Initially, a minimum of 100 subjects will be enrolled to receive DTG 50mg twice daily with the current failing regimen for 7 days but with OBR from Day 8. Subjects must also have documented genotypic and/or phenotypic resistance to at least one compound in two or more of the other approved classes of ART but must also be able to include at least one fully active drug in the OBR to be started Day 8. The first data cut will take place after the (approximate) 100th subject enrolled completes the Week 24 visit. Enrollment will continue until a further 50 to 100 subjects have been recruited. All subjects who successfully complete 24 weeks of treatment will continue to have access to DTG until it is locally available as long as they continue to derive clinical benefit.

ViiV Healthcare is the sponsor of this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Screening plasma HIV-1 RNA ≥500 copies/mL
  • ART-experienced, INI-experienced, DTG naïve
  • Experienced virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen
  • The subject's HIV-1 shows resistance to RAL or ELV at Screening or at prior time point of virological failure on RAL or ELV
  • Documented resistance to at least one drug from each of three or more of all approved classes of ART
  • Be able to receive at least one fully active drug as part of the OBR from Day 8
  • Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
  • Willing and able to understand and provide signed and dated written informed consent prior to Screening.

Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • An active AIDS-defining condition at Screening (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ <200c/mm3)
  • Moderate to severe hepatic impairment as defined by Child-Pugh classification
  • Anticipated need for HCV therapy during the first 24 weeks of the study
  • Recent history of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding
  • Allergy or intolerance to the study drugs or their components or drugs of their class
  • Malignancy within the past 6 months
  • Treatment with an HIV-1 therapeutic vaccine within 90 days of Screening
  • Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
  • Treatment with any agent, other than licensed ART, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product
  • Treatment with etravirine, efavirenz, or nevirapine within 14 days of Day 1(etravirine may be used if coadministered with lopinivir/ritonavir or darunavir/ritonavir)
  • Treatment with tipranivir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir within 28 days prior to Screening
  • Verified Grade 4 laboratory abnormality at Screening
  • ALT> 5 times the upper limit of normal (ULN) at Screening
  • ALT ≥ 3X ULN and bilirubin > 1.5 X ULN (with 35% direct bilirubin) at Screening
  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: NCT01328041

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90211
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Los Angeles, California, United States, 90069
GSK Investigational Site
San Diego, California, United States, 92103-8208
GSK Investigational Site
San Francisco, California, United States, 94109
United States, Connecticut
GSK Investigational Site
New Haven, Connecticut, United States, 06510
GSK Investigational Site
Norwalk, Connecticut, United States, 06850
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20009
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Fort Pierce, Florida, United States, 34982
GSK Investigational Site
Miami Beach, Florida, United States, 33139
GSK Investigational Site
Orlando, Florida, United States, 32804
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Louisiana
GSK Investigational Site
Lafayette, Louisiana, United States, 70506
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39216-4505
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89106
United States, New Jersey
GSK Investigational Site
Newark, New Jersey, United States, 07103
United States, New York
GSK Investigational Site
Albany, New York, United States, 12209
GSK Investigational Site
Bronx, New York, United States, 10467
GSK Investigational Site
Bronx, New York, United States, 10461
GSK Investigational Site
Buffalo, New York, United States, 14215
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
New York, New York, United States, 10016
GSK Investigational Site
Valhalla, New York, United States, 10595
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
Toledo, Ohio, United States, 43614
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02906
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Dallas, Texas, United States, 75204
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Houston, Texas, United States, 77098
United States, Virginia
GSK Investigational Site
Annandale, Virginia, United States, 22003
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Liege, Belgium, 4000
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2C7
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1L6
GSK Investigational Site
Toronto, Ontario, Canada, M4T 3A7
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
GSK Investigational Site
Montreal, Quebec, Canada, H2X 2P4
GSK Investigational Site
Montreal, Quebec, Canada, H3G 1A4
GSK Investigational Site
Montreal, Quebec, Canada, H2W 1T8
GSK Investigational Site
Montreal, Quebec, Canada, H2L 5B1
France
GSK Investigational Site
Aulnay-sous-Bois, France, 93602
GSK Investigational Site
Bobigny, France, 93009
GSK Investigational Site
Bordeaux, France, 33000
GSK Investigational Site
Garches, France, 92380
GSK Investigational Site
Gonesse cedex, France, 95503
GSK Investigational Site
Marseille, France, 13003
GSK Investigational Site
Marseille, France, 13009
GSK Investigational Site
Nice, France, 06202
GSK Investigational Site
Orléans Cedex 2, France, 45067
GSK Investigational Site
Paris, France, 75018
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Paris Cedex 13, France, 75651
GSK Investigational Site
Paris cedex 14, France, 75679
GSK Investigational Site
Paris cedex 15, France, 75743
GSK Investigational Site
Paris Cedex 20, France, 75970
Italy
GSK Investigational Site
Genova, Liguria, Italy, 16138
GSK Investigational Site
Bergamo, Lombardia, Italy, 24128
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Torino, Piemonte, Italy, 10149
GSK Investigational Site
Bagno a Ripoli (FI), Toscana, Italy, 50011
GSK Investigational Site
Firenze, Toscana, Italy, 50134
Portugal
GSK Investigational Site
Amadora, Portugal
GSK Investigational Site
Coimbra, Portugal, 3030
GSK Investigational Site
Lisboa, Portugal, 1349-019
GSK Investigational Site
Lisboa, Portugal, 1150
GSK Investigational Site
Lisboa, Portugal, 1649-035
Spain
GSK Investigational Site
Alicante, Spain, 03010
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Cartagena (Murcia), Spain, 30202
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28029
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Sevilla, Spain, 41013
Sponsors and Collaborators
ViiV Healthcare
Shionogi
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided by ViiV Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01328041     History of Changes
Other Study ID Numbers: 112574
Study First Received: March 31, 2011
Results First Received: August 15, 2013
Last Updated: October 30, 2014
Health Authority: Italy: AIFA - Italian Ministry of Health
Spain: Agencia Española del Medicamento y Productos Sanitarios
Portugal: Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Belgium: Agence Fédérale des Medicaments et des Produits de la Santé
United States: Food and Drug Administration
Canada: Health Canada
France: Agence Française de Sécurité Sanitaire des Produits de Santé

Keywords provided by ViiV Healthcare:
resistance to raltegravir or elvitegravir
GSK1349572
ART-experienced
Integrase inhibitor
dolutegravir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Dolutegravir
Integrase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014