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Dolutegravir Expanded Access Study (DEAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 5, 2016
Last verified: December 2016

February 16, 2012
December 5, 2016
June 2012
August 2018   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01536873 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Dolutegravir Expanded Access Study
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

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.

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Infection, Human Immunodeficiency Virus
Drug: Dolutegravir
Eligible patients will receive DTG 50 mg given orally BID
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2018
August 2018   (final data collection date for primary outcome measure)

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 -
Both
12 Years to 99 Years   (Child, Adult, Senior)
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United States,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Italy,   Poland
 
NCT01536873
114916
No
Undecided
Not Provided
ViiV Healthcare
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
December 2016

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