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

NCT ID: NCT00819052

Last Updated: 2014-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NVP IR

200 mg orally twice a day (po BID)

Group Type ACTIVE_COMPARATOR

Nevirapine XR

Intervention Type DRUG

Nevirapine XR

Nevirapine IR

Intervention Type DRUG

Nevirapine Immediate Release

NVP XR

400 mg orally once a day (po QD)

Group Type EXPERIMENTAL

Nevirapine XR

Intervention Type DRUG

Nevirapine extended release

Interventions

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Nevirapine XR

Nevirapine XR

Intervention Type DRUG

Nevirapine XR

Nevirapine extended release

Intervention Type DRUG

Nevirapine IR

Nevirapine Immediate Release

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

HIV infected subjects treated with a Viramune based regimen.


1. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
2. HIV-1 infected males or females of at least 18 years.
3. Treatment with Viramune regimen for at least the preceding 18 weeks.
4. Background therapy with lamivudine/ abacavir(3TC/ABC) (Kivexa® in EU; Epzicom in US), emtricitabine/tenofovir( FTC/TDF) (Truvada) or lamivudine/zidovudine 3TC/AZT (Combivir®).
5. An HIV viral load \< 50 copies/mL in preceding 3 months.
6. An HIV viral load of \< 50 copies/mL at screening (Visit 1).
7. 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).
8. 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.
9. Karnofsky performance score of \< 70

Exclusion Criteria

Subjects who meet one or more of the following criteria will be excluded from the study:

1. Current treatment with an HIV protease inhibitor
2. Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study
3. Female patients of child-bearing potential who:

1. Have a positive serum pregnancy test at screening.
2. Are breast feeding.
3. Are planning to become pregnant
4. 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..
4. 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)
5. Laboratory parameters \> DAIDS grade 3 Total triglycerides (total cholesterol no restriction)
6. Hypersensitivity to any ingredients of the test products
7. Active drug abuse or chronic alcoholism.
8. Hepatic cirrhosis stage Child-Pugh B or C
9. 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
10. Inability to comply with protocol requirements
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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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1100.1526.1012 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Site Status

1100.1526.1014 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Site Status

1100.1526.1011 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Site Status

1100.1526.1013 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1100.1526.1001 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Site Status

1100.1526.1004 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Site Status

1100.1526.1006 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1100.1526.1002 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1100.1526.1005 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

Site Status

1100.1526.1003 Boehringer Ingelheim Investigational Site

Berkley, Michigan, United States

Site Status

1100.1526.1007 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

1100.1526.3306A Boehringer Ingelheim Investigational Site

Bobigny, , France

Site Status

1100.1526.3311A Boehringer Ingelheim Investigational Site

Bordeaux, , France

Site Status

1100.1526.3307A Boehringer Ingelheim Investigational Site

La Roche-sur-Yon, , France

Site Status

1100.1526.3312A Boehringer Ingelheim Investigational Site

Le Kremlin-Bicêtre, , France

Site Status

1100.1526.3301A Boehringer Ingelheim Investigational Site

Lyon, , France

Site Status

1100.1526.3310A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1100.1526.3308A Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

1100.1526.3302A Boehringer Ingelheim Investigational Site

Nantes, , France

Site Status

1100.1526.3304A Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1100.1526.4902 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1100.1526.4903 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1100.1526.4904 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

1100.1526.4905 Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

1100.1526.4907 Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

1100.1526.4914 Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

1100.1526.4906 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1100.1526.4909 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1100.1526.4908 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Site Status

1100.1526.4901 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

Site Status

1100.1526.4910 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1100.1526.4911 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1100.1526.4912 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1100.1526.4913 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1100.1526.4915 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1100.1526.4403 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1100.1526.4405 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1100.1526.4404 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

1100.1526.4402 Boehringer Ingelheim Investigational Site

Tooting, London, , United Kingdom

Site Status

Countries

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United States France Germany United Kingdom

Other Identifiers

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2008-004681-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1100.1526

Identifier Type: -

Identifier Source: org_study_id