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Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients

NCT ID: NCT00543803

Last Updated: 2014-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

334 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Brief Summary

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This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
* Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
* Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Exclusion Criteria

* Age \< 18 years
* Pregnant female patients
* Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).
* Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
* Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) \> 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised \< 5 ULN.
* Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT \> 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)
* Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine
* The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.
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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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Aachen, , Germany

Site Status

1100.1492.1 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 10

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 11

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 12

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 13

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 14

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 1

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 2

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 3

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 4

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 5

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 6

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 7

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 8

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 9

Berlin, , Germany

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Boehringer Ingelheim Investigational Site 1

Cologne, , Germany

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Boehringer Ingelheim Investigational Site 2

Cologne, , Germany

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Boehringer Ingelheim Investigational Site 3

Cologne, , Germany

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Boehringer Ingelheim Investigational Site

Dortmund, , Germany

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Boehringer Ingelheim Investigational Site

Duisburg, , Germany

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Boehringer Ingelheim Investigational Site 1

Düsseldorf, , Germany

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Boehringer Ingelheim Investigational Site 2

Düsseldorf, , Germany

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Boehringer Ingelheim Investigational Site

Frankfurt (Oder), , Germany

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Boehringer Ingelheim Investigational Site 1

Frankfurt am Main, , Germany

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Boehringer Ingelheim Investigational Site 2

Frankfurt am Main, , Germany

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Boehringer Ingelheim Investigational Site 3

Frankfurt am Main, , Germany

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Boehringer Ingelheim Investigational Site 4

Frankfurt am Main, , Germany

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Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

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Boehringer Ingelheim Investigational Site 1

Hamburg, , Germany

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Boehringer Ingelheim Investigational Site 2

Hamburg, , Germany

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Boehringer Ingelheim Investigational Site 3

Hamburg, , Germany

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Boehringer Ingelheim Investigational Site 4

Hamburg, , Germany

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Boehringer Ingelheim Investigational Site 1

Hanover, , Germany

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Boehringer Ingelheim Investigational Site 2

Hanover, , Germany

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Boehringer Ingelheim Investigational Site

Karlsruhe, , Germany

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Boehringer Ingelheim Investigational Site

Koblenz, , Germany

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Boehringer Ingelheim Investigational Site 1

Leipzig, , Germany

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Boehringer Ingelheim Investigational Site 2

Leipzig, , Germany

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Boehringer Ingelheim Investigational Site

Magdeburg, , Germany

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Boehringer Ingelheim Investigational Site

Mainz, , Germany

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Boehringer Ingelheim Investigational Site

Mannheim, , Germany

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Boehringer Ingelheim Investigational Site 1

München, , Germany

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Boehringer Ingelheim Investigational Site 2

München, , Germany

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Boehringer Ingelheim Investigational Site 3

München, , Germany

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Boehringer Ingelheim Investigational Site 4

München, , Germany

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Boehringer Ingelheim Investigational Site 5

München, , Germany

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Boehringer Ingelheim Investigational Site 1

Münster, , Germany

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Boehringer Ingelheim Investigational Site 2

Münster, , Germany

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Boehringer Ingelheim Investigational Site 3

Münster, , Germany

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Boehringer Ingelheim Investigational Site 4

Münster, , Germany

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Boehringer Ingelheim Investigational Site 1

Nuremberg, , Germany

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Boehringer Ingelheim Investigational Site 2

Nuremberg, , Germany

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Boehringer Ingelheim Investigational Site

Oldenburg, , Germany

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Boehringer Ingelheim Investigational Site

Osnabrück, , Germany

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Boehringer Ingelheim Investigational Site

Potsdam, , Germany

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Boehringer Ingelheim Investigational Site

Saarbrücken, , Germany

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Boehringer Ingelheim Investigational Site 1

Stuttgart, , Germany

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Boehringer Ingelheim Investigational Site 2

Stuttgart, , Germany

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Boehringer Ingelheim Investigational Site 3

Stuttgart, , Germany

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Boehringer Ingelheim Investigational Site

Troisdorf, , Germany

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Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

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Boehringer Ingelheim Investigational Site

Wuppertal, , Germany

Site Status

Countries

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Germany

Related Links

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http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1492_Literature.pdf

Related Info

Other Identifiers

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1100.1492

Identifier Type: -

Identifier Source: org_study_id

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