Clinical trial NCT01134939: Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
Official title: Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients

Brief 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.

Detailed description: Time Perspective:

retro- and prospective

Eligibility 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

Primary outcomes:
measure: Number of Patients With Virologic Response (VR) After 36 Months
timeFrame: 36 months
Secondary outcomes:
measure: Changes in the Viral Load After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the CD4+ Cell Count After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data ( ALT) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (AST) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
timeFrame: Baseline and 36 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site 23
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 10
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 11
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 14
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 19
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 26
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 28
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 33
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 8
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 9
city: Chemnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site 31
city: Dortmund
country: Germany
facility: Boehringer Ingelheim Investigational Site 29
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 27
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 17
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Giessen
country: Germany
facility: Boehringer Ingelheim Investigational Site 34
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 22
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 6
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 12
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 16
city: Karlsruhe
country: Germany
facility: Boehringer Ingelheim Investigational Site 32
city: Koblenz
country: Germany
facility: Boehringer Ingelheim Investigational Site 15
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site 25
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site 21
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 20
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 24
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 7
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 13
city: Osnabrück
country: Germany
facility: Boehringer Ingelheim Investigational Site 18
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 30
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: