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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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