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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:
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

July 7, 2008
February 3, 2014
September 2008
July 2011   (final data collection date for primary outcome measure)
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.
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 ] [ 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
Secondary endpoints are the virologic response at week 48 and change in CD4 cell count from baseline to week 48. [ Time Frame: 48 Weeks ]
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients

HIV Infections
Not Provided
Patients HIV-1 positive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
Not Provided
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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Poland
 
NCT00736502
1100.1527
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP