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 9, 2015
Last verified: January 2015
  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:
  • Number of Patients With Virologic Response (VR) After 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart.

    A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml.



Secondary Outcome Measures:
  • Changes in the Viral Load After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.

  • Changes in the CD4+ Cell Count After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.

  • Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data ( ALT) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data (AST) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .

  • Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
    The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .


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 9
Berlin, Germany
Boehringer Ingelheim Investigational Site 10
Berlin, Germany
Boehringer Ingelheim Investigational Site 11
Berlin, Germany
Boehringer Ingelheim Investigational Site 14
Berlin, Germany
Boehringer Ingelheim Investigational Site 19
Berlin, Germany
Boehringer Ingelheim Investigational Site 28
Berlin, Germany
Boehringer Ingelheim Investigational Site 33
Berlin, Germany
Boehringer Ingelheim Investigational Site 4
Berlin, Germany
Boehringer Ingelheim Investigational Site 5
Berlin, Germany
Boehringer Ingelheim Investigational Site 8
Berlin, Germany
Boehringer Ingelheim Investigational Site 26
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 24
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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional 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
Results First Received: December 31, 2014
Last Updated: January 9, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on August 27, 2015