Overview

Dolutegravir Expanded Access Study

Status:
Completed
Trial end date:
2016-09-23
Target enrollment:
0
Participant gender:
All
Summary
ING114916 is an open-label, multi-center, expanded access (EAP) study
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Treatments:
Dolutegravir
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.

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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 -