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 -