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Dolutegravir Expanded Access Study (DEAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by ViiV Healthcare
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01536873
First received: February 16, 2012
Last updated: November 15, 2016
Last verified: November 2016
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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: NCT01536873

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

  Show 74 Study Locations
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 
Study First Received: February 16, 2012
Last Updated: November 15, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 02, 2016