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Dolutegravir Expanded Access Study (DEAP)

Expanded access is currently available for this treatment.
Verified December 2011 by ViiV Healthcare
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01536873
First received: February 16, 2012
Last updated: February 21, 2012
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention
Infection, Human Immunodeficiency Virus
 Drug: dolutegravir

Study Type: Expanded Access     What is Expanded Access?
Official Title: A GSK1349572 Open Label Protocol for HIV Infected, Adult Patients With Integrase Resistance

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Study Start Date: February 2012
Intervention Details:
    Drug: dolutegravir
    integrase inhibitor in development
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:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Adult subjects greater than 18 years of age, documented HIV-1 RNA >/= 400 c/mL, documented raltegravir or elvitegravir resistance, inability to construct a viable background ART regimen with commercially available medications.

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Exclusion Criteria: Creatnine clearance < 30ml/min via Cockcroft-Gault method, females who are pregnant and/or breastfeeding, patients with known integrase allergic reaction, ALT > 5 times the ULN within one month of treatment initiation, ALT > 3 times ULN and total bilirubin >1.5 times ULN, evidence of severe hepatic impairment, patients eligible for, and have access to, an actively enrolling DTG Phase III clinical study, any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications

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  Contacts and Locations
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

Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01536873     History of Changes
Other Study ID Numbers: 114916
Study First Received: February 16, 2012
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
treatment experienced patients
Integrase resistance

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013