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Observational Non-Interventional Study With Viramune® in Combination With Truvada® in HIV-Infected Patients
This study is ongoing, but not recruiting participants.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00543803
  Purpose

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).


Condition
HIV Infections

MedlinePlus related topics: AIDS
Drug Information available for: Nevirapine Truvada
U.S. FDA Resources
Study Type: Observational
Official Title: Observational Non-Interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • safety [ Time Frame: Antiretroviral effect at the 48th week ]

Estimated Enrollment: 420
Study Start Date: February 2006
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To construct a treatment option with Viramune (nevirapine) and Truvada (fixed dose combination of tenofovir and emtricitabine) in 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 PI or NNRTI 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 ASAT or ALAT > 5 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 John¿s 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543803

Locations
Germany
Boehringer Ingelheim
Aachen, Germany
Boehringer Ingelheim
Berlin, Germany
Boehringer Ingelheim
Dortmund, Germany
Boehringer Ingelheim
Duisburg, Germany
Boehringer Ingelheim
Düsseldorf, Germany
Boehringer Ingelheim
Frankfurt/Main, Germany
Boehringer Ingelheim
Frankfurt/Oder, Germany
Boehringer Ingelheim
Freiburg, Germany
Boehringer Ingelheim
Hamburg, Germany
Boehringer Ingelheim
Hannover, Germany
Boehringer Ingelheim
Karlsruhe, Germany
Boehringer Ingelheim
Koblenz, Germany
Boehringer Ingelheim
Köln, Germany
Boehringer Ingelheim
Leipzig, Germany
Boehringer Ingelheim
Wuppertal, Germany
Boehringer Ingelheim
Mainz, Germany
Boehringer Ingelheim
Mannheim, Germany
Boehringer Ingelheim
München, Germany
Boehringer Ingelheim
Münster, Germany
Boehringer Ingelheim
Nürnberg, Germany
Boehringer Ingelheim
Oldenburg, Germany
Boehringer Ingelheim
Osnabrück, Germany
Boehringer Ingelheim
Potsdam, Germany
Boehringer Ingelheim
Saarbrücken, Germany
Boehringer Ingelheim
Stuttgart, Germany
Boehringer Ingelheim
Troisdorf, Germany
Boehringer Ingelheim
Wiesbaden, Germany
Boehringer Ingelheim
Magdeburg, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1100.1492
Study First Received: October 8, 2007
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00543803  
Health Authority: Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica

Study placed in the following topic categories:
Virus Diseases
Nevirapine
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009