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 (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

Protekt-Kohorte

AcronymISRCTNEudraCTNCT (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 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)

Responsibilities in overall study

Abbott Laboratories

    Sponsor representative

    Dunja Diarra

    Prof. Dr. med. Jan Rupp