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

Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

Detailed Description

Time Perspective:

retro- and prospective

• Study Type: Observational
• Enrollment (Actual): 265

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HIV-infected women and men

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Virologic Response (VR) After 36 Months	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.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Viral Load After 36 Months From Baseline	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.	Baseline and 36 months
Changes in the CD4+ Cell Count After 36 Months From Baseline	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.	Baseline and 36 months
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data ( ALT) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data (AST) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline	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. .	Baseline and 36 months
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline	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. .	Baseline and 36 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 1, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 9, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 1100.1536

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No