Non-interventional Observational Study With Viramune in HIV to Evaluate Gender Specific Data - Full Text View

Purpose

The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded depending on gender and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.

Condition
HIV Infections

Study Type:	Observational
Study Design:	Observational Model: Cohort
Official Title:	Non-interventional Observational Study With Viramune Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Nevirapine

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Collection of AEs and SAEs [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Variations in laboratory values from normal levels as well as changes in comparison to baseline values [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Lessening (or maintenance) of the virus load to a value that is below the detection limit. Change in the CD4 cell count from baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	342
Study Start Date:	May 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
HIV-infected women and men

Detailed Description:

Time Perspective:

retro- and prospective

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 for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC

Exclusion criteria:

The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134939

Locations

Germany
Boehringer Ingelheim Investigational Site 23
Aachen, Germany
Boehringer Ingelheim Investigational Site 9
Berlin, Germany
Boehringer Ingelheim Investigational Site 33
Berlin, Germany
Boehringer Ingelheim Investigational Site 4
Berlin, Germany
Boehringer Ingelheim Investigational Site 19
Berlin, Germany
Boehringer Ingelheim Investigational Site 28
Berlin, Germany
Boehringer Ingelheim Investigational Site 8
Berlin, Germany
Boehringer Ingelheim Investigational Site 5
Berlin, Germany
Boehringer Ingelheim Investigational Site 10
Berlin, Germany
Boehringer Ingelheim Investigational Site 26
Berlin, Germany
Boehringer Ingelheim Investigational Site 14
Berlin, Germany
Boehringer Ingelheim Investigational Site 11
Berlin, Germany
Boehringer Ingelheim Investigational Site 31
Chemnitz, Germany
Boehringer Ingelheim Investigational Site 29
Dortmund, Germany
Boehringer Ingelheim Investigational Site 27
Düsseldorf, Germany
Boehringer Ingelheim Investigational Site 1
Frankfurt, Germany
Boehringer Ingelheim Investigational Site 17
Frankfurt, Germany
Boehringer Ingelheim Investigational Site 2
Freiburg, Germany
Boehringer Ingelheim Investigational Site 34
Giessen, Germany
Boehringer Ingelheim Investigational Site 22
Hamburg, Germany
Boehringer Ingelheim Investigational Site 6
Hamburg, Germany
Boehringer Ingelheim Investigational Site 12
Hannover, Germany
Boehringer Ingelheim Investigational Site 16
Hannover, Germany
Boehringer Ingelheim Investigational Site 32
Karlsruhe, Germany
Boehringer Ingelheim Investigational Site 15
Koblenz, Germany
Boehringer Ingelheim Investigational Site 25
Köln, Germany
Boehringer Ingelheim Investigational Site 21
Leipzig, Germany
Boehringer Ingelheim Investigational Site 24
München, Germany
Boehringer Ingelheim Investigational Site 7
München, Germany
Boehringer Ingelheim Investigational Site 3
München, Germany
Boehringer Ingelheim Investigational Site 20
München, Germany
Boehringer Ingelheim Investigational Site 13
Münster, Germany
Boehringer Ingelheim Investigational Site 18
Osnabrück, Germany
Boehringer Ingelheim Investigational Site 30
Stuttgart, Germany

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01134939 History of Changes
Other Study ID Numbers:	1100.1536
Study First Received:	June 1, 2010
Last Updated:	May 2, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

Nevirapine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013