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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:
ClinicalTrials.gov Identifier:
NCT00736502
First Posted: August 18, 2008
Last Update Posted: March 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
July 7, 2008
August 18, 2008
July 30, 2012
August 31, 2012
March 7, 2014
September 2008
July 2011   (Final data collection date for primary outcome measure)
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.
The primary objective is to evaluate the safety of a HAART regimen that includes Viramune� in clinical practice. [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00736502 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Secondary endpoints are the virologic response at week 48 and change in CD4 cell count from baseline to week 48. [ Time Frame: 48 Weeks ]
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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.
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
patients
HIV Infections
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Patients HIV-1 positive
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
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July 2011   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Poland
 
 
NCT00736502
1100.1527
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Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014