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:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00736502
First received: July 7, 2008
Last updated: September 13, 2012
Last verified: September 2012
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Proportion of Patients Reporting Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
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+ 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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| 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: | September 13, 2012 |
| 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 May 19, 2013