PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.
Longterm Efficacy and Safety of NVP-based HAART in HIV-1 Positive Patients in the Daily Clinical Practice.
1 other identifier
observational
280
2 countries
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
August 18, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedResults Posted
Study results publicly available
August 31, 2012
CompletedMarch 7, 2014
February 1, 2014
2.8 years
July 7, 2008
July 30, 2012
February 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Reporting Adverse Events
the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.
48 weeks
Secondary Outcomes (2)
Virologic Response (VR)
48 weeks
Change in CD4+ Cell Count From Baseline to Week 48
Baseline and week 48
Study Arms (1)
Patients HIV-1 positive
Eligibility Criteria
patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Boehringer Ingelheim Investigational Site 1
Graz, Austria
Boehringer Ingelheim Investigational Site 2
Linz, Austria
Boehringer Ingelheim Investigational Site 3
Salzburg, Austria
Boehringer Ingelheim Investigational Site 4
Vienna, Austria
Boehringer Ingelheim Investigational Site 5
Vienna, Austria
Boehringer Ingelheim Investigational Site 6
Vienna, Austria
Boehringer Ingelheim Investigational Site 7
Wels, Austria
Boehringer Ingelheim Investigational Site 8
Bialystok, Poland
Boehringer Ingelheim Investigational Site 9
Bydgoszcz, Poland
Boehringer Ingelheim Investigational Site 10
Chorzów, Poland
Boehringer Ingelheim Investigational Site 11
Gdansk, Poland
Boehringer Ingelheim Investigational Site 12
Krakow, Poland
Boehringer Ingelheim Investigational Site 13
Lódz, Poland
Boehringer Ingelheim Investigational Site 14
Poznan, Poland
Boehringer Ingelheim Investigational Site 15
Szczecin, Poland
Boehringer Ingelheim Investigational Site 16
Warsaw, Poland
Boehringer Ingelheim Investigational Site 17
Wroclaw, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2008
First Posted
August 18, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2011
Last Updated
March 7, 2014
Results First Posted
August 31, 2012
Record last verified: 2014-02