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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00736502
First received: July 7, 2008
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longterm Efficacy and Safety of NVP-based HAART in HIV-1 Positive Patients in the Daily Clinical Practice.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Proportion of Patients Reporting Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.


Secondary Outcome Measures:
  • Virologic Response (VR) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 48 ] [ Designated as safety issue: No ]
    Calculated as CD4+ cell count at week 48 minus the baseline value


Enrollment: 280
Study Start Date: September 2008
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients HIV-1 positive

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736502

Locations
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, Austria
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, Poland
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00736502     History of Changes
Other Study ID Numbers: 1100.1527
Study First Received: July 7, 2008
Results First Received: July 30, 2012
Last Updated: February 3, 2014
Health Authority: Austria: Agency for Health and Food Safety
Poland: Registration Medicinal Product Medical Device Biocidal Product

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014