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

NCT ID: NCT01134939

Last Updated: 2015-01-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Time Perspective:

retro- and prospective

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Groups

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HIV-infected women and men

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site 23

Aachen, , Germany

Site Status

Boehringer Ingelheim Investigational Site 10

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 11

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 14

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 19

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 26

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 28

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 33

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 4

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 5

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 8

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 9

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site 31

Chemnitz, , Germany

Site Status

Boehringer Ingelheim Investigational Site 25

Cologne, , Germany

Site Status

Boehringer Ingelheim Investigational Site 29

Dortmund, , Germany

Site Status

Boehringer Ingelheim Investigational Site 27

Düsseldorf, , Germany

Site Status

Boehringer Ingelheim Investigational Site 17

Frankfurt, , Germany

Site Status

Boehringer Ingelheim Investigational Site 1

Frankfurt, , Germany

Site Status

Boehringer Ingelheim Investigational Site 2

Freiburg im Breisgau, , Germany

Site Status

Boehringer Ingelheim Investigational Site 34

Giessen, , Germany

Site Status

Boehringer Ingelheim Investigational Site 22

Hamburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site 6

Hamburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site 12

Hanover, , Germany

Site Status

Boehringer Ingelheim Investigational Site 16

Hanover, , Germany

Site Status

Boehringer Ingelheim Investigational Site 32

Karlsruhe, , Germany

Site Status

Boehringer Ingelheim Investigational Site 15

Koblenz, , Germany

Site Status

Boehringer Ingelheim Investigational Site 21

Leipzig, , Germany

Site Status

Boehringer Ingelheim Investigational Site 20

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site 24

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site 3

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site 7

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site 13

Münster, , Germany

Site Status

Boehringer Ingelheim Investigational Site 18

Osnabrück, , Germany

Site Status

Boehringer Ingelheim Investigational Site 30

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1100.1536

Identifier Type: -

Identifier Source: org_study_id

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