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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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 (NVP IR) based regimen for at least 18 prior weeks of therapy.

Key facts

Study ID: NCT00819052
Run by: Boehringer Ingelheim
People needed: 445
Starts: 2008-12-01
Expected to finish: 2012-01-01
Last updated by the study team: 2014-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

1100.1526.1012 Boehringer Ingelheim Investigational Site — Beverly Hills, California, United States
1100.1526.1014 Boehringer Ingelheim Investigational Site — Beverly Hills, California, United States
1100.1526.1011 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
1100.1526.1013 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
1100.1526.1001 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
1100.1526.1004 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
1100.1526.1006 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
1100.1526.1002 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
1100.1526.1005 Boehringer Ingelheim Investigational Site — Miami Beach, Florida, United States
1100.1526.1003 Boehringer Ingelheim Investigational Site — Berkley, Michigan, United States
1100.1526.1007 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
1100.1526.3306A Boehringer Ingelheim Investigational Site — Bobigny, France
1100.1526.3311A Boehringer Ingelheim Investigational Site — Bordeaux, France
1100.1526.3307A Boehringer Ingelheim Investigational Site — La Roche-sur-Yon, France
1100.1526.3312A Boehringer Ingelheim Investigational Site — Le Kremlin-Bicêtre, France
1100.1526.3301A Boehringer Ingelheim Investigational Site — Lyon, France
1100.1526.3310A Boehringer Ingelheim Investigational Site — Marseille, France
1100.1526.3308A Boehringer Ingelheim Investigational Site — Montpellier, France
1100.1526.3302A Boehringer Ingelheim Investigational Site — Nantes, France
1100.1526.3304A Boehringer Ingelheim Investigational Site — Nice, France
1100.1526.4902 Boehringer Ingelheim Investigational Site — Berlin, Germany
1100.1526.4903 Boehringer Ingelheim Investigational Site — Berlin, Germany
1100.1526.4904 Boehringer Ingelheim Investigational Site — Bochum, Germany
1100.1526.4905 Boehringer Ingelheim Investigational Site — Bonn, Germany
1100.1526.4907 Boehringer Ingelheim Investigational Site — Cologne, Germany

Full record on ClinicalTrials.gov

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