| Status | Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
|---|---|---|---|---|---|
| Active | GSK1349572 | NCT01536873 |
A GSK1349572 Open label Protocol for HIV infectected, Adult patients with Integrase Resistance
Purpose / Objectives
Diagnosis
- HIV-1
HIV-1 infection with documented RAL or ELV resistance
Target population
Age
18-99
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
Exclusion criteria
- Creatnine clearance < 30ml/min via Cockcroft- Gaultmethod
- 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
Study design
- Multicenter
- Open Label
Intervention
| Condition | Intervention |
|---|---|
| Infection, Human Immunodeficiency Virus | Drug: dolutegravir |
Documents (password protected)
Go to download area (no documents yet)
Networks
- DZIF TI Clinical Trial Unit
- DZIF-CTU Hannover
Responsibilities in overall study
Sponsor
ViiV Healthcare
- Tel. +44 (0)20 8380 6200