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.

HIV Infections Clinical Trial

Official title:

Longterm Efficacy and Safety of NVP-based HAART in HIV-1 Positive Patients in the Daily Clinical Practice.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736502
• Other study ID #: 1100.1527
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: February 3, 2014
• Start date: September 2008

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyPoland: Registration Medicinal Product Medical Device Biocidal Product
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Austria	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
Poland	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	Kraków
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	Warszawa
Poland	Boehringer Ingelheim Investigational Site 17	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Virologic Response (VR)	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.	48 weeks	No
Secondary	Change in CD4+ Cell Count From Baseline to Week 48	Calculated as CD4+ cell count at week 48 minus the baseline value	Baseline and week 48	No