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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002368
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2002
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nevirapine
Drug: Lamivudine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 2000
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00002368

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002368     History of Changes
Other Study ID Numbers: 200E, 1100.1090
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Nevirapine
Lamivudine
Disease Progression
Reverse Transcriptase Inhibitors
Anti-HIV Agents

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

ClinicalTrials.gov processed this record on September 11, 2014