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Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice

NCT ID: NCT01524900

Last Updated: 2015-06-02

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

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-05-31

Brief Summary

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This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and pre-treated patients switching from nevirapine immediate release or other anti-retroviral therapy (ART) will be included in the study. The decision to initiate treatment with nevirapine extended release is independent of this study and is based entirely on individual patient need and the judgement of the treating physician. The aim of the study is to assess the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1 infected patients in routine clinical practice. It is planned to document five visits for each patient over a twenty four week observational period.

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Detailed Description

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Study Design:

non-interventional uncontrolled observational study

Conditions

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HIV Infections

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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nevirapine extended release

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. HIV-1 infected male and female 18 years and above;
2. anti-retroviral therapy (ART) naive and pre-treated patients switching from a nevirapine immediate release or other ART.

Exclusion Criteria

Consistent with the current VIRAMUNE prolonged release SPC.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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 6

Graz, , Austria

Site Status

Boehringer Ingelheim Investigational Site 5

Salzburg, , Austria

Site Status

Boehringer Ingelheim Investigational Site 1

Vienna, , Austria

Site Status

Boehringer Ingelheim Investigational Site 2

Vienna, , Austria

Site Status

Boehringer Ingelheim Investigational Site 3

Vienna, , Austria

Site Status

Boehringer Ingelheim Investigational Site 4

Wels, , Austria

Site Status

Boehringer Ingelheim Investigational Site 7

Bialystok, , Poland

Site Status

Boehringer Ingelheim Investigational Site 8

Bialystok, , Poland

Site Status

Boehringer Ingelheim Investigational Site 10

Bydgoszcz, , Poland

Site Status

Boehringer Ingelheim Investigational Site 9

Bydgoszcz, , Poland

Site Status

Boehringer Ingelheim Investigational Site 11

Chorzów, , Poland

Site Status

Boehringer Ingelheim Investigational Site 12

Chorzów, , Poland

Site Status

Boehringer Ingelheim Investigational Site 13

Gdañsk, , Poland

Site Status

Boehringer Ingelheim Investigational Site 14

Gdañsk, , Poland

Site Status

Boehringer Ingelheim Investigational Site 15

Gdañsk, , Poland

Site Status

Boehringer Ingelheim Investigational Site 16

Krakow, , Poland

Site Status

Boehringer Ingelheim Investigational Site 17

Krakow, , Poland

Site Status

Boehringer Ingelheim Investigational Site 18

Poznañ, , Poland

Site Status

Boehringer Ingelheim Investigational Site 19

Wroc£aw, , Poland

Site Status

Boehringer Ingelheim Investigational Site 20

Wroc£aw, , Poland

Site Status

Boehringer Ingelheim Investigational Site 50

Bacau, , Romania

Site Status

Boehringer Ingelheim Investigational Site 51

Brasov, , Romania

Site Status

Boehringer Ingelheim Investigational Site 52

Brasov, , Romania

Site Status

Boehringer Ingelheim Investigational Site 53

Brasov, , Romania

Site Status

Boehringer Ingelheim Investigational Site 21

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 22

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 23

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 24

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 25

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 26

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 27

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 28

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 29

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 30

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 31

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 32

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 33

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 34

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 35

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 36

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 37

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 38

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 39

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 40

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 41

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 42

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 43

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 44

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational Site 46

Constanța, , Romania

Site Status

Boehringer Ingelheim Investigational Site 47

Constanța, , Romania

Site Status

Boehringer Ingelheim Investigational Site 48

Constanța, , Romania

Site Status

Boehringer Ingelheim Investigational Site 45

Giurgiu, , Romania

Site Status

Boehringer Ingelheim Investigational Site 49

Ploieşti, , Romania

Site Status

Countries

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Austria Poland Romania

Other Identifiers

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1100.1550

Identifier Type: -

Identifier Source: org_study_id

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