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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01536873
Recruitment Status : Unknown
Verified January 2017 by ViiV Healthcare.
Recruitment status was:  Recruiting
First Posted : February 22, 2012
Last Update Posted : January 18, 2017
Information provided by (Responsible Party):
ViiV Healthcare

February 16, 2012
February 22, 2012
January 18, 2017
June 2012
August 2018   (Final data collection date for primary outcome measure)
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 Provided
Complete list of historical versions of study NCT01536873 on Archive Site
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 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.

Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
Unknown status
Not Provided
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 -
Sexes Eligible for Study: All
12 Years to 99 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Italy,   Poland,   United States
Not Provided
Plan to Share IPD: Undecided
ViiV Healthcare
ViiV Healthcare
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
January 2017

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