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.

Completed

• Conditions: HIV Infections

• Registration Number: NCT00736502
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Study Start: 2008-09
• Primary Completion: 2011-07
• Results First Submitted: 2012-07-30
• Results First Submitted QC: 2012-07-30
• Results First Posted: 2012-08-31
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Reporting Adverse Events	48 weeks	the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.

Secondary Outcome Measures

Name	Time	Method
Virologic Response (VR)	48 weeks	VR was defined as Human immunodeficiency virus (HIV) viral load of \<50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) \>= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL \< 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.
Change in CD4+ Cell Count From Baseline to Week 48	Baseline and week 48	Calculated as CD4+ cell count at week 48 minus the baseline value

Trial Locations

Locations (17)

Boehringer Ingelheim Investigational Site 12; 🇵🇱 Kraków, Poland

Boehringer Ingelheim Investigational Site 3; 🇦🇹 Salzburg, Austria

Boehringer Ingelheim Investigational Site 1; 🇦🇹 Graz, Austria

Boehringer Ingelheim Investigational Site 2; 🇦🇹 Linz, Austria

Boehringer Ingelheim Investigational Site 6; 🇦🇹 Vienna, Austria

Boehringer Ingelheim Investigational Site 8; 🇵🇱 Bialystok, Poland

Boehringer Ingelheim Investigational Site 15; 🇵🇱 Szczecin, Poland

Boehringer Ingelheim Investigational Site 4; 🇦🇹 Vienna, Austria

Boehringer Ingelheim Investigational Site 5; 🇦🇹 Vienna, Austria

Boehringer Ingelheim Investigational Site 13; 🇵🇱 Lódz, Poland

Boehringer Ingelheim Investigational Site 17; 🇵🇱 Wroclaw, 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 14; 🇵🇱 Poznan, Poland

Boehringer Ingelheim Investigational Site 16; 🇵🇱 Warszawa, Poland

Boehringer Ingelheim Investigational Site 7; 🇦🇹 Wels, Austria