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Status:

COMPLETED

Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients

Lead Sponsor:

Boehringer Ingelheim

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NV...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • HIV infected subjects treated with a Viramune based regimen.
  • A subject that meets the following inclusion criteria will be eligible for participation in this study:
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
  • HIV-1 infected males or females of at least 18 years.
  • Treatment with Viramune regimen for at least the preceding 18 weeks.
  • Background therapy with lamivudine/ abacavir(3TC/ABC) (Kivexa® in EU; Epzicom in US), emtricitabine/tenofovir( FTC/TDF) (Truvada) or lamivudine/zidovudine 3TC/AZT (Combivir®).
  • An HIV viral load \< 50 copies/mL in preceding 3 months.
  • An HIV viral load of \< 50 copies/mL at screening (Visit 1).
  • Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions: alanine aminotrnasferase (ALT) and asparatate aminotransferase (AST) \< 2.5 × upper limit of normal (ULN) Division of Acquired Immunodeficiency Syndrome (DAIDS Grade 1).
  • Willingness to abstain from ingesting medications that are listed as contraindicated in the Summary of Product Characteristics (SPC) or package insert (or PI) or Investigator's Brochure during the study.
  • Karnofsky performance score of \< 70
  • Exclusion criteria:
  • Subjects who meet one or more of the following criteria will be excluded from the study:
  • Current treatment with an HIV protease inhibitor
  • Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study
  • Female patients of child-bearing potential who:
  • Have a positive serum pregnancy test at screening.
  • Are breast feeding.
  • Are planning to become pregnant
  • Are not willing to use a double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception, or require ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms..
  • Laboratory parameters \> DAIDS grade 2 Coagulation prothrombin time (PT), partial thromboplastin time (PTT), International Normalized ratio (INR) Hematology (absolute platelets, white blood cells (WBC), absolute neutrophil count, hemoglobin) Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, lactate, alkaline phosphatase)
  • Laboratory parameters \> DAIDS grade 3 Total triglycerides (total cholesterol no restriction)
  • Hypersensitivity to any ingredients of the test products
  • Active drug abuse or chronic alcoholism.
  • Hepatic cirrhosis stage Child-Pugh B or C
  • History of severe or acute illness within 60 days prior to Day 1, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the trial
  • Inability to comply with protocol requirements

Exclusion

    Key Trial Info

    Start Date :

    December 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2012

    Estimated Enrollment :

    445 Patients enrolled

    Trial Details

    Trial ID

    NCT00819052

    Start Date

    December 1 2008

    End Date

    January 1 2012

    Last Update

    November 10 2014

    Active Locations (39)

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    Page 1 of 10 (39 locations)

    1

    1100.1526.1012 Boehringer Ingelheim Investigational Site

    Beverly Hills, California, United States

    2

    1100.1526.1014 Boehringer Ingelheim Investigational Site

    Beverly Hills, California, United States

    3

    1100.1526.1011 Boehringer Ingelheim Investigational Site

    Long Beach, California, United States

    4

    1100.1526.1013 Boehringer Ingelheim Investigational Site

    Los Angeles, California, United States