A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

Verified by: Boehringer Ingelheim Pharmaceuticals, June 2011
First Received: September 14, 2009 | Last Updated: June 15, 2011 | Phase: N/A | Start Date: September 2009
Overall Status: Completed | Estimated Enrollment: 51
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The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor...

Brief Summary

Official Title: “A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Tipranavir (Aptivus®) Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.”

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: May 2011

Arms, Groups and Cohorts in this Clinical Trial

  • : Patients with HIV-1 infection

Outcome Measures for this Clinical Trial

Primary Measures

  • The primary objective is to evaluate the safety of a HAART regimen that includes Aptivus coadministered with low dose of ritonavir in clinical practice
    • Time Frame: 48 weeks
      Safety Issue?: No

Secondary Measures

  • Secondary endpoints are the virologic response at week 48 and change in CD4plus cell count from baseline to week 48.
    • Time Frame: 48 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion criteria:

  • 1. HIV-1 infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than one protease inhibitor and no other therapeutic options.
  • 2. The inclusion criteria follow the same criteria which are describe in the newest SPC

Exclusion criteria:

  • The exclusion criteria follow the same criteria which are describe in the newest SPC

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00976950

Study ID Number: 1182.147

ClinicalTrials.gov Identifier: NCT00976950

Health Authority: Romania: National Medicines Agency

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00976950