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

NCT00819052 | Completed Phase 3 Results

• 2 other identifiers: 1100.15262008-004681-55
• Study Type: interventional
• Target: 445
• Locations: 4 countries
• Sites: 39

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population

  Primary endpoint was the number of patients with a sustained virologic response through week 24

  week 24

Secondary Outcomes (42)

• Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population

  week 2

• Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population

  week 4

• Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population

  week 8

• Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population

  week 12

• Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population

  week 24

Study Arms (2)

NVP IR

ACTIVE COMPARATOR

200 mg orally twice a day (po BID)

Drug: Nevirapine XR; Drug: Nevirapine IR

NVP XR

EXPERIMENTAL

400 mg orally once a day (po QD)

Drug: Nevirapine XR

Interventions

Nevirapine XR DRUG

Nevirapine XR

NVP IR

Nevirapine IR DRUG

Nevirapine Immediate Release

NVP IR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected subjects treated with a Viramune based regimen.
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (39)

1100.1526.1012 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1100.1526.1014 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1100.1526.1011 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1100.1526.1013 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1100.1526.1001 Boehringer Ingelheim Investigational Site

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

Location

1100.1526.1004 Boehringer Ingelheim Investigational Site

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

Location

1100.1526.1006 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1100.1526.1002 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1100.1526.1005 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

Location

1100.1526.1003 Boehringer Ingelheim Investigational Site

Berkley, Michigan, United States

Location

1100.1526.1007 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1100.1526.3306A Boehringer Ingelheim Investigational Site

Bobigny, France

Location

1100.1526.3311A Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

1100.1526.3307A Boehringer Ingelheim Investigational Site

La Roche-sur-Yon, France

Location

1100.1526.3312A Boehringer Ingelheim Investigational Site

Le Kremlin-Bicêtre, France

Location

1100.1526.3301A Boehringer Ingelheim Investigational Site

Lyon, France

Location

1100.1526.3310A Boehringer Ingelheim Investigational Site

Marseille, France

Location

1100.1526.3308A Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1100.1526.3302A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1526.3304A Boehringer Ingelheim Investigational Site

Nice, France

Location

1100.1526.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1100.1526.4903 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1100.1526.4904 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

1100.1526.4905 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

1100.1526.4907 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1100.1526.4914 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1100.1526.4906 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1100.1526.4909 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1100.1526.4908 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1100.1526.4901 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1100.1526.4910 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1100.1526.4911 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1100.1526.4912 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1100.1526.4913 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1100.1526.4915 Boehringer Ingelheim Investigational Site

München, Germany

Location

1100.1526.4403 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1100.1526.4405 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1100.1526.4404 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1100.1526.4402 Boehringer Ingelheim Investigational Site

Tooting, London, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 10, 2014
• Results First Posted: February 24, 2012

Record last verified: 2014-11

Locations

FR (9); GB (4); US (11); DE (15)