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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134939
• Other study ID #: 1100.1536
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: January 9, 2015
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

Description:

Time Perspective:

retro- and prospective

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Germany	Boehringer Ingelheim Investigational Site 23	Aachen
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	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 20	München
Germany	Boehringer Ingelheim Investigational Site 24	München
Germany	Boehringer Ingelheim Investigational Site 3	München
Germany	Boehringer Ingelheim Investigational Site 7	München
Germany	Boehringer Ingelheim Investigational Site 13	Münster
Germany	Boehringer Ingelheim Investigational Site 18	Osnabrück
Germany	Boehringer Ingelheim Investigational Site 30	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Link