Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01134939
First received: June 1, 2010
Last updated: January 13, 2014
Last verified: January 2014
  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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Collection of AEs and SAEs [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Variations in laboratory values from normal levels as well as changes in comparison to baseline values [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of virologic responses (VR) after 36 months, defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the viral load [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Changes in the CD4+ cell count [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Changes in the laboratory data (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, blood glucose, ALT, AST, gamma-GT, creatinine, haemoglobin) [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 265
Study Start Date: May 2010
Study Completion Date: December 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Boehringer Ingelheim Investigational Site 23
Aachen, Germany
Boehringer Ingelheim Investigational Site 11
Berlin, Germany
Boehringer Ingelheim Investigational Site 9
Berlin, Germany
Boehringer Ingelheim Investigational Site 33
Berlin, Germany
Boehringer Ingelheim Investigational Site 5
Berlin, Germany
Boehringer Ingelheim Investigational Site 28
Berlin, Germany
Boehringer Ingelheim Investigational Site 8
Berlin, Germany
Boehringer Ingelheim Investigational Site 19
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 4
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 7
München, Germany
Boehringer Ingelheim Investigational Site 3
München, Germany
Boehringer Ingelheim Investigational Site 20
München, Germany
Boehringer Ingelheim Investigational Site 24
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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01134939     History of Changes
Other Study ID Numbers: 1100.1536
Study First Received: June 1, 2010
Last Updated: January 13, 2014
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

ClinicalTrials.gov processed this record on October 16, 2014