Trial record 1 of 1 for:    ING114916
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Dolutegravir Expanded Access Study (DEAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by ViiV Healthcare.
Recruitment status was  Available
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

February 16, 2012
February 21, 2012
February 2012
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Complete list of historical versions of study NCT01536873 on ClinicalTrials.gov Archive Site
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Dolutegravir Expanded Access Study
A GSK1349572 Open Label Protocol for HIV Infected, Adult Patients With Integrase Resistance

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

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.

Expanded Access
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Infection, Human Immunodeficiency Virus
Drug: dolutegravir
integrase inhibitor in development
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
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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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Both
18 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
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NCT01536873
114916
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP