The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs

An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS Progression Events or Death When Used in Combination With Lamivudine (3TC) and Stable (>= 4 Weeks) Background Nucleoside Therapy

To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Nevirapine; Drug: Lamivudine

Detailed Description

Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.

• Study Type: Interventional
• Enrollment: 2000
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36104
      • Drug Research and Analysis Corp
  • California
    • Los Angeles, California, United States, 90067
      • Dr G Michael Wool
    • Los Angeles, California, United States, 900951793
      • UCLA School of Medicine / Ctr for Research and Education
    • Palo Alto, California, United States, 94304
      • AIDS Research Ctr / Palo Alto VA Health Care System
    • Redwood City, California, United States, 94063
      • AIDS Community Research Consortium
    • San Francisco, California, United States, 94109
      • ViRx Inc
    • San Francisco, California, United States, 94110
      • San Francisco Gen Hosp / UCSF AIDS Program
    • Torrance, California, United States, 90502
      • Harbor - UCLA Med Ctr
  • Colorado
    • Colorado Springs, Colorado, United States, 80903
      • Infectious Disease Specialists
    • Denver, Colorado, United States, 80204
      • Denver Public Health
    • Denver, Colorado, United States, 80205
      • Dr Miguel Mogyoros / Clinical Research Dept
  • Delaware
    • Wilmington, Delaware, United States, 19801
      • Wilmington Hosp
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Novum Inc
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • North Broward Hosp District
    • Fort Lauderdale, Florida, United States, 33308
      • Anthony LaMarca
    • Fort Myers, Florida, United States, 33901
      • Dr Robert Schwartz
    • Fort Myers, Florida, United States, 33901
      • McGregor Clinic / Lee County Public Health Unit
    • Jacksonville, Florida, United States, 32216
      • P Andrew Coley
    • Maitland, Florida, United States, 32751
      • Goodgame Med Group
    • Tampa, Florida, United States, 33614
      • Infectious Disease Research Institute Inc
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Ctr
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Dr John Pottage
    • Chicago, Illinois, United States, 60611
      • Northwestern Univ / Division of Infectious Diseases
    • Chicago, Illinois, United States, 60612
      • Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Univ Med School
  • Iowa
    • Des Moines, Iowa, United States, 50325
      • Dr Daniel H Gervich
    • Iowa City, Iowa, United States, 52242
      • Univ of Iowa
  • Kentucky
    • Lexington, Kentucky, United States, 40563
      • Univ of Kentucky Med Cntr / Dept of Med / Div of ID
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Med Research Ctr
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • New England Med Ctr
    • Boston, Massachusetts, United States, 02215
      • New England Deaconess Hosp
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Hosp / Virology Research Clinic
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • International Medicine and Infectious Disease
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Trinity Lutheran Hosp / HIV Program
  • New Jersey
    • Somerville, New Jersey, United States, 08876
      • Infectious Disease Associates of Central New Jersey
  • New York
    • Buffalo, New York, United States, 14215
      • SUNY / Erie County Med Ctr at Buffalo
    • New York, New York, United States, 10014
      • Dr David Kaufman
    • Staten Island, New York, United States, 10310
      • Saint Vincent Med Ctr
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74114
      • Associates in Med and Mental Health
  • Oregon
    • Portland, Oregon, United States, 97210
      • The Research and Education Group
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Med Ctr / Dept of Med / Div of Hematology
    • Philadelphia, Pennsylvania, United States, 19104
      • Univ of Pennsylvania / Division of Infectious Diseases
    • Pittsburgh, Pennsylvania, United States, 152063817
      • Novum Inc
  • Rhode Island
    • Providence, Rhode Island, United States, 02907
      • Omega Med Research
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Med Univ of South Carolina / Div of Infect Dis
    • Columbia, South Carolina, United States, 29206
      • Dr Alfred Burnside
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • Dr Susie Sargent
  • Texas
    • Dallas, Texas, United States, 75219
      • Nelson Tebedo Health Resource Ctr
    • Galveston, Texas, United States, 775550835
      • Univ of Texas Med Branch / Div of Infectious Dis
    • Houston, Texas, United States, 77006
      • Houston Clinical Research Network / Div of Montrose Clinic
    • Irving, Texas, United States, 75038
      • Walter Gaman
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Hampton Roads Med Specialists
  • Washington
    • Seattle, Washington, United States, 981225314
      • Advanced Research Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Patients must have:

• Documented HIV infection.
• CD4+ cell count <= 200 cells/mm3.
• Life expectancy > 3 months.
• Written informed consent from parent or guardian for patients < 18 years of age.
• Willingness and ability to follow protocol requirements.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions or symptoms are excluded:

Patient is enrolled or plans to enroll during the course of this study in another clinical study of an antiretroviral or other agent used to treat HIV-1 infection.

• NOTE:
• Patients are allowed to participate in opportunistic infection clinical studies if the investigational agent is not contraindicated for the study.

Concurrent Medication:

Excluded:

• Patient is receiving therapy with an antiretroviral agent other than ZDV, d4T, ddI, ddC, or 3TC.
• Patient is receiving acute therapy for a clinical AIDS progression event such as systemic chemotherapy.
• Dicumarol, Warfarin and other anticoagulant medications.
• Tolbutamide.
• Investigational drugs (unless included in opportunistic infection clinical trial) and all antiretroviral agents (excluding ZDV, ddC, ddI, d4T and 3TC).
• Neurotoxic drugs.
• Cimetidine.
• Erythromycin.

Concurrent Treatment:

Excluded:

Radiation therapy.

Patients with any of the following prior conditions and symptoms are excluded:

History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this study.

Prior Medication:

Excluded:

• Patient has received prior therapy with Viramune or any other non-nucleoside reverse transcriptase inhibitor.
• Patient has received any immunosuppressive or cytotoxic drugs or any other experimental agent within 4 weeks prior to study day 1.
• Patient has received treatment with erythromycin, coumadin/warfarin, phenobarbital, amoxicillin/clavulanic acid, or ticarcillin/clavulanic acid within 2 weeks prior to study day 0.

Risk Behavior:

Excluded:

Patients who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements.

Required:

Patient must be receiving stable nucleoside therapy with at least one agent for >= 4 weeks prior to study day 0. Zidovudine (ZDV), Zidovudine + Dideoxycytidine (ddC), or Zidovudine + Didanosine (ddI) must be used unless prior intolerance precludes ZDV use. Stable use means no change in dose > 50% for any background nucleoside within four weeks prior to study day 0.

NOTE:

• If patient is ZDV intolerant, ddC, ddI or D4T monotherapy is allowed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: August 1, 2002

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Nevirapine; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Lamivudine; Acquired Immunodeficiency Syndrome; Disease Progression
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Nevirapine; Lamivudine
• Other Study ID Numbers: 200E; 1100.1090