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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00543803
First received: October 8, 2007
Last updated: May 13, 2014
Last verified: May 2014
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
    The change in alanine aminotransferase (ALT) from baseline to the last value in treatment

  • Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
    The change in asparate aminotransferase (AST) from baseline to the last value in treatment

  • Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
    The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment

  • Summary of Change From Baseline in Creatinine to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in Creatinine from baseline to the last value in treatment

  • Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in total cholesterol from baseline to the last value in treatment

  • Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment

  • Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment

  • Summary of Change From Baseline in Triglycerides to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in triglycerides from baseline to the last value in treatment

  • Summary of Change From Baseline in Glucose to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in Glucose from baseline to the last value in treatment


Secondary Outcome Measures:
  • Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    For calculation of this measure switch patients are included in the total which had no viral load decrease.

  • Summary of Change From Baseline in CD4+ Count to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
  • Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
    Total number of patients with investigator defined non-serious drug-related AEs was reported.

  • Investigator's Global Clinical Assessment of Patient General Health Status [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    Investigators opinion of patients general health condition at baseline versus last evaluation on treatment


Enrollment: 334
Study Start Date: February 2006
Primary Completion Date: December 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
Sampling Method:   Non-Probability Sample
Study Population

HIV Patients

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543803

  Show 63 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00543803     History of Changes
Other Study ID Numbers: 1100.1492
Study First Received: October 8, 2007
Results First Received: December 17, 2010
Last Updated: May 13, 2014
Health Authority: Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 19, 2014