Clinical Trials
As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.
The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.
For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit.
GSK1349572 Open label Protocol EAP
- Overall study
- Study Sites (1)
| Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
|---|---|---|---|---|
| GSK1349572 | NCT01536873 |
A GSK1349572 Open label Protocol for HIV infectected, Adult patients with Integrase Resistance
Status: Active
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)
Responsibilities in overall study
Sponsor
ViiV Healthcare
- Tel. +44 (0)20 8380 6200