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.
Protekt-Kohorte
- Overall study
- Study Sites (1)
Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|
PMOS GERM 07-11 |
Status: Active
Purpose / Objectives
Primary Outcome
To assess the tolerability of lopinavir/r in combination with a Integrase Inhibitor
Secondary Outcomes
To characterize the development of resistance.
To assess the development of CD4 cell count.
Diagnosis
- HIV-1
- Infectiology/HIV and AIDS
HIV-1 infected patients
Target population
Inclusion criteria
Patients that will be treated with Kaletra, independent from their participation in this study
Patients that will be treated with an Integrase Inhibitor, independent from their participation in this study
Exclusion criteria
The exclusion criteria are as stated in the German Summary of Product Characteristics (SPC) for Kaletra (Appendix I) and Integrase Inhibitors (Appendix II)
Study design
- Multicenter
Intervention
Non-interventional study
Documents (password protected)
Go to download area (no documents yet)
Responsibilities in overall study
Sponsor
Abbott Laboratories
Sponsor representative
Dunja Diarra
- Tel. +49 451 500 6092
- Fax +49 451 500 5864
- dunja.diarra@uksh.de
Prof. Dr. med. Jan Rupp
- Tel. 0451 - 500-4409
- Fax 0451 - 500-4274
- jan.rupp@uk-sh.de