PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in the Daily Clinical Practice in Poland.
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: viramune (Drug)
Phase: N/A
Status: 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 Viramune® on a background of different antiretroviral drug combinations.
Clinical Details
Official title: Longterm Efficacy and Safety of NVP-based HAART in HIV-1 Positive Patients 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 Viramune® in clinical practice.
Secondary outcome: Secondary endpoints are the virologic response at week 48 and change in CD4 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:
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
Boehringer Ingelheim Investigational Site, LINZ, Austria; Recruiting
Boehringer Ingelheim Investigational Site, SALZBURG, Austria; Recruiting
Boehringer Ingelheim Investigational Site, WELS, Austria; Recruiting
Boehringer Ingelheim Investigational Site, WIEN, Austria; Recruiting
Boehringer Ingelheim Investigational Site, BIALYSTOK, Poland; Recruiting
Boehringer Ingelheim Investigational Site, BYDGOSZCZ, Poland; Recruiting
Boehringer Ingelheim Investigational Site, CHORZĂ“W, Poland; Recruiting
Boehringer Ingelheim Investigational Site, GDANSK, Poland; Recruiting
Boehringer Ingelheim Investigational Site, KRAKĂ“W, Poland; Recruiting
Boehringer Ingelheim Investigational Site, LĂ“DZ, Poland; Recruiting
Boehringer Ingelheim Investigational Site, POZNAN, Poland; Recruiting
Boehringer Ingelheim Investigational Site, SZCZECIN, Poland; Recruiting
Boehringer Ingelheim Investigational Site, WARSZAWA, Poland; Recruiting
Boehringer Ingelheim Investigational Site, WROCLAW, Poland; Recruiting
Additional Information
Starting date: September 2008
Last updated: September 24, 2009
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