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.

February 3, 2014 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Boehringer Ingelheim Investigational Site 1
      • Linz, Austria
        • Boehringer Ingelheim Investigational Site 2
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site 3
      • Vienna, Austria
        • Boehringer Ingelheim Investigational Site 4
      • Vienna, Austria
        • Boehringer Ingelheim Investigational Site 5
      • Vienna, Austria
        • Boehringer Ingelheim Investigational Site 6
      • Wels, Austria
        • Boehringer Ingelheim Investigational Site 7
  • Poland
      • Bialystok, Poland
        • Boehringer Ingelheim Investigational Site 8
      • Bydgoszcz, Poland
        • Boehringer Ingelheim Investigational Site 9
      • Chorzów, Poland
        • Boehringer Ingelheim Investigational Site 10
      • Gdansk, Poland
        • Boehringer Ingelheim Investigational Site 11
      • Kraków, Poland
        • Boehringer Ingelheim Investigational Site 12
      • Lódz, Poland
        • Boehringer Ingelheim Investigational Site 13
      • Poznan, Poland
        • Boehringer Ingelheim Investigational Site 14
      • Szczecin, Poland
        • Boehringer Ingelheim Investigational Site 15
      • Warszawa, Poland
        • Boehringer Ingelheim Investigational Site 16
      • Wroclaw, Poland
        • Boehringer Ingelheim Investigational Site 17

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients HIV-1 positive

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virologic Response (VR)
Time Frame: 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.
48 weeks
Change in CD4+ Cell Count From Baseline to Week 48
Time Frame: Baseline and week 48
Calculated as CD4+ cell count at week 48 minus the baseline value
Baseline and week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (ESTIMATE)

August 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1100.1527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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