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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00819052
First received: January 7, 2009
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nevirapine XR
Drug: Nevirapine IR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    Primary endpoint was the number of patients with a sustained virologic response through week 24


Secondary Outcome Measures:
  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 2

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 4

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 8

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 12

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 24

  • Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 0 to 24 ] [ Designated as safety issue: No ]
  • Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
  • Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 48

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 60 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 60

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 72 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 72

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 84 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 84

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 96 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 96

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 108 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 108

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 120 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 120

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 132 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 132

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: week 144 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 144

  • Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [ Time Frame: last available visit, up to 144 weeks ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response at their last available visit

  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 48 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 60 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 72 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 84 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 96 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 108 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 120 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 132 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, week 144 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population [ Time Frame: baseline, last available visit (up to 144 weeks) ] [ Designated as safety issue: No ]
  • Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 [ Time Frame: week 144 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 144

  • Change From Baseline in VL (HIV-1 Viral Load) at Each Visit [ Time Frame: week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit ] [ Designated as safety issue: No ]
  • Changes in Safety Parameters Related to Treatment [ Time Frame: until week 144 ] [ Designated as safety issue: No ]
    Occurence of investigations related to treatment

  • Occurence of Rashes [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
    drug-related rashes by severity

  • Occurence of Hepatic Events [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • New AIDS or AIDS-related Progression Event or Death [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]

Enrollment: 445
Study Start Date: December 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NVP IR
200 mg orally twice a day (po BID)
Drug: Nevirapine XR
Nevirapine XR
Drug: Nevirapine IR
Nevirapine Immediate Release
Experimental: NVP XR
400 mg orally once a day (po QD)
Drug: Nevirapine XR
Nevirapine extended release

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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
  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: NCT00819052

  Hide Study Locations
Locations
United States, California
1100.1526.1014 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1100.1526.1012 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
United States, District of Columbia
1100.1526.1001 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
1100.1526.1004 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
United States, Florida
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
United States, Michigan
1100.1526.1003 Boehringer Ingelheim Investigational Site
Berkley, Michigan, United States
United States, Texas
1100.1526.1007 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
France
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 Cedex, France
1100.1526.3301A Boehringer Ingelheim Investigational Site
Lyon Cedex 3, France
1100.1526.3310A Boehringer Ingelheim Investigational Site
Marseille cedex 9, France
1100.1526.3308A Boehringer Ingelheim Investigational Site
Montpellier cedex 5, France
1100.1526.3302A Boehringer Ingelheim Investigational Site
Nantes, France
1100.1526.3304A Boehringer Ingelheim Investigational Site
Nice cedex 3, France
Germany
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
1100.1526.4906 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1100.1526.4909 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1100.1526.4908 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
1100.1526.4901 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1100.1526.4912 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1100.1526.4910 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1100.1526.4911 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1100.1526.4913 Boehringer Ingelheim Investigational Site
Hannover, Germany
1100.1526.4914 Boehringer Ingelheim Investigational Site
Köln, Germany
1100.1526.4907 Boehringer Ingelheim Investigational Site
Köln, Germany
1100.1526.4915 Boehringer Ingelheim Investigational Site
München, Germany
United Kingdom
1100.1526.4405 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1526.4403 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1526.4404 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1100.1526.4402 Boehringer Ingelheim Investigational Site
Tooting, London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00819052     History of Changes
Other Study ID Numbers: 1100.1526, 2008-004681-55
Study First Received: January 7, 2009
Results First Received: December 13, 2011
Last Updated: February 24, 2014
Health Authority: France: AFSSAPS
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authorities for Drugs and Medical Products)
Great Britain: MHRA
United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nevirapine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014