APost 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.
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Tipranavir (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Overall contact:
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
Summary
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.
Clinical Details
Official title: A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Tipranavir (AptivusŪ) Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.
Study design: Other, Prospective
Primary outcome: The primary objective is to evaluate the safety of a HAART regimen that includes Aptivus coadministered with low dose of ritonavir in clinical practice
Secondary outcome: Secondary endpoints are the virologic response at week 48 and change in CD4plus cell count from baseline to week 48.
Detailed description:
Study Design:
Non-interventional, post marketing study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com Additional Information
Starting date: September 2009
Last updated: October 8, 2009
|
