Dolutegravir Expanded Access Study (DEAP)

September 28, 2020 updated by: ViiV Healthcare

A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance

ING114916 is an open-label, multi-center, expanded access (EAP) study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Not applicable for an expanded access study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Not applicable for an expanded access study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2012

Primary Completion (Actual)

September 23, 2016

Study Completion (Actual)

September 23, 2016

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimate)

February 22, 2012

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114916
  • 2011-001646-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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