We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dolutegravir Expanded Access Study (DEAP)

This study is currently recruiting participants.
Verified January 2017 by ViiV Healthcare
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536873
First Posted: February 22, 2012
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
  Purpose
ING114916 is an open-label, multi-center, expanded access (EAP) study

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Expanded access [ Time Frame: Not applicable for an expanded access study ]
    To to provide access in an open label protocol program to patients who have documented RAL or ELV resistance, who have limited treatment options and who require DTG to construct a viable ARV regimen for therapy


Secondary Outcome Measures:
  • Assess adverse events [ Time Frame: Not applicable for an expanded access study ]
    Assess any serious adverse events (SAEs) and adverse events (AEs) that lead to the discontinuation of DTG 50 mg BID


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dolutegravir
    Eligible patients will receive DTG 50 mg given orally BID
Detailed Description:

ING114916 is an open-label, multi-center EAP to allow access to patients with HIV-1 infection who have documented raltegravir or elvitegravir resistance, have limited treatment options and require dolutegravir to construct a viable anti-retroviral regimen for therapy. Patients must not be eligible for another ongoing dolutegravir clinical trial in order to participate in this EAP.

The duration of patient accrual into the study will extend until dolutegravir receives local (by country) regulatory approval.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Adult subjects greater than 18 years of age 2. Documented HIV-1 RNA >/= 400 c/mL 3. Documented raltegravir or elvitegravir resistance 4. Inability to construct a viable background ART regimen with commercially available medications.

Exclusion Criteria:

  1. Creatnine clearance < 30ml/min via Cockcroft-Gault method
  2. Females who are pregnant and/or breastfeeding
  3. Patients with known integrase allergic reaction
  4. ALT > 5 times the ULN within one month of treatment initiation
  5. ALT > 3 times ULN and total bilirubin >1.5 times ULN
  6. Evidence of severe hepatic impairment
  7. Patients eligible for, and have access to, an actively enrolling DTG Phase III clinical study
  8. Any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536873


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site Completed
Phoenix, Arizona, United States, 85012
United States, California
GSK Investigational Site Completed
San Francisco, California, United States, 94115
United States, Colorado
GSK Investigational Site Completed
Denver, Colorado, United States, 80218
United States, Florida
GSK Investigational Site Completed
Fort Lauderdale, Florida, United States, 33311
GSK Investigational Site Completed
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site Completed
Orlando, Florida, United States, 32803
GSK Investigational Site Completed
St. Petersburg, Florida, United States, 33701
GSK Investigational Site Recruiting
Vero Beach, Florida, United States, 32960
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Georgia
GSK Investigational Site Completed
Atlanta, Georgia, United States, 30322
United States, Illinois
GSK Investigational Site Completed
Chicago, Illinois, United States, 60612
GSK Investigational Site Completed
Chicago, Illinois, United States, 60613
GSK Investigational Site Completed
Chicago, Illinois, United States, 60657
United States, Kansas
GSK Investigational Site Completed
Topeka, Kansas, United States, 66606
United States, Missouri
GSK Investigational Site Completed
St. Louis, Missouri, United States, 63139
United States, Nebraska
GSK Investigational Site Completed
Omaha, Nebraska, United States, 68198
United States, New York
GSK Investigational Site Completed
Bronx, New York, United States, 1057
GSK Investigational Site Completed
New York, New York, United States, 10011
United States, North Carolina
GSK Investigational Site Completed
Chapel Hill, North Carolina, United States, 27599-7215
United States, Pennsylvania
GSK Investigational Site Completed
Lancaster, Pennsylvania, United States, 17604
GSK Investigational Site Completed
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
GSK Investigational Site Completed
Austin, Texas, United States, 78705
GSK Investigational Site Completed
Dallas, Texas, United States, 75204
GSK Investigational Site Completed
Houston, Texas, United States, 77004
GSK Investigational Site Completed
Houston, Texas, United States, 77098
Austria
GSK Investigational Site Completed
Graz, Austria, A-8020
GSK Investigational Site Completed
Linz, Austria, A-4020
GSK Investigational Site Completed
Vienna, Austria, A-1140
Belgium
GSK Investigational Site Completed
Antwerpen, Belgium, 2000
GSK Investigational Site Completed
Brussels, Belgium, 1000
GSK Investigational Site Completed
Liege, Belgium, 4000
Brazil
GSK Investigational Site Recruiting
Ipanema, Rio De Janeiro, Brazil, 22410-906
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Macae, Rio De Janeiro, Brazil, 27910-210
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 2006
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Sao Paulo, São Paulo, Brazil, 04121-000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Fortaleza, Brazil, 60455-610
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Maceió, Brazil, 57035-110
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Ribeirão Preto, Brazil, 14048-900
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Rio de Janeiro, Brazil, 20520-054
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Rio de Janeiro, Brazil, 20725-090
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Rio de Janeiro, Brazil, 21040-900
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Sao Paulo, Brazil, 01246-000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Vittoria, Brazil, 29020-020
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Canada, British Columbia
GSK Investigational Site Completed
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
GSK Investigational Site Completed
Hamilton, Ontario, Canada, L8N3Z5
GSK Investigational Site Completed
Toronto, Ontario, Canada, M5G 1K2
Canada, Quebec
GSK Investigational Site Completed
Montreal, Quebec, Canada, H2L 4P9
France
GSK Investigational Site Completed
Bordeaux cedex, France, 33076
GSK Investigational Site Completed
Le Kremlin-Bicêtre Cedex, France, 94275
GSK Investigational Site Completed
Marseille, France, 13274
GSK Investigational Site Completed
Nice, France, 06202
GSK Investigational Site Completed
Paris Cedex 10, France, 75475
GSK Investigational Site Completed
Paris Cedex 14, France, 75679
GSK Investigational Site Completed
Paris Cedex 18, France, 75877
GSK Investigational Site Completed
Paris Cedex 20, France, 75970
GSK Investigational Site Completed
Paris, France, 75012
GSK Investigational Site Completed
Paris, France, 75013
GSK Investigational Site Completed
Paris, France, 75015
Germany
GSK Investigational Site Completed
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site Completed
Stuttgart, Baden-Wuerttemberg, Germany, 70197
GSK Investigational Site Completed
Frankfurt, Hessen, Germany, 60596
GSK Investigational Site Completed
Osnabrueck, Niedersachsen, Germany, 49090
GSK Investigational Site Completed
Bonn, Nordrhein-Westfalen, Germany, 53127
GSK Investigational Site Completed
Koeln, Nordrhein-Westfalen, Germany, 50674
GSK Investigational Site Completed
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site Completed
Mannheim, Germany, 68161
Italy
GSK Investigational Site Completed
Genova, Liguria, Italy, 16128
GSK Investigational Site Completed
Genova, Liguria, Italy, 16132
GSK Investigational Site Completed
Milano, Lombardia, Italy, 20127
GSK Investigational Site Completed
Pavia, Lombardia, Italy, 27100
GSK Investigational Site Completed
Bagno a Ripoli (FI), Toscana, Italy, 50011
GSK Investigational Site Completed
Firenze, Toscana, Italy, 50134
GSK Investigational Site Completed
Modena, Italy, 41124
GSK Investigational Site Completed
Venezia, Italy, 30122
Poland
GSK Investigational Site Completed
Szczecin, Poland, 71-455
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01536873     History of Changes
Other Study ID Numbers: 114916
First Submitted: February 16, 2012
First Posted: February 22, 2012
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by ViiV Healthcare:
treatment experienced patients
Integrase resistance

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