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

June 1, 2010
January 9, 2015
May 2010
December 2013   (final data collection date for primary outcome measure)
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.

  • 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 ]
Complete list of historical versions of study NCT01134939 on ClinicalTrials.gov Archive Site
  • 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. .
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 ]
Not Provided
Not Provided
 
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.

Time Perspective:

retro- and prospective

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

patients

HIV Infections
Not Provided
HIV-infected women and men
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
December 2013
December 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01134939
1100.1536
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP