Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active PMOS GERM 07-11

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)

Responsibilities in overall study

Sponsor

Abbott Laboratories

Sponsor representative

Dunja Diarra

Prof. Dr. med. Jan Rupp