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
2 other identifiers
interventional
2,000
1 country
53
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 2002
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Drug Research and Analysis Corp
Montgomery, Alabama, 36104, United States
Dr G Michael Wool
Los Angeles, California, 90067, United States
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, 900951793, United States
AIDS Research Ctr / Palo Alto VA Health Care System
Palo Alto, California, 94304, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
ViRx Inc
San Francisco, California, 94109, United States
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Infectious Disease Specialists
Colorado Springs, Colorado, 80903, United States
Denver Public Health
Denver, Colorado, 80204, United States
Dr Miguel Mogyoros / Clinical Research Dept
Denver, Colorado, 80205, United States
Wilmington Hosp
Wilmington, Delaware, 19801, United States
Novum Inc
Washington D.C., District of Columbia, 20037, United States
Anthony LaMarca
Fort Lauderdale, Florida, 33308, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33316, United States
Dr Robert Schwartz
Fort Myers, Florida, 33901, United States
McGregor Clinic / Lee County Public Health Unit
Fort Myers, Florida, 33901, United States
P Andrew Coley
Jacksonville, Florida, 32216, United States
Goodgame Med Group
Maitland, Florida, 32751, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
Palm Beach Research Ctr
West Palm Beach, Florida, 33409, United States
Dr John Pottage
Chicago, Illinois, 60610, United States
Northwestern Univ / Division of Infectious Diseases
Chicago, Illinois, 60611, United States
Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
Chicago, Illinois, 60612, United States
Indiana Univ Med School
Indianapolis, Indiana, 46202, United States
Dr Daniel H Gervich
Des Moines, Iowa, 50325, United States
Univ of Iowa
Iowa City, Iowa, 52242, United States
Univ of Kentucky Med Cntr / Dept of Med / Div of ID
Lexington, Kentucky, 40563, United States
Med Research Ctr
New Orleans, Louisiana, 70112, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Beth Israel Hosp / Virology Research Clinic
Boston, Massachusetts, 02215, United States
New England Deaconess Hosp
Boston, Massachusetts, 02215, United States
International Medicine and Infectious Disease
Minneapolis, Minnesota, 55407, United States
Trinity Lutheran Hosp / HIV Program
Kansas City, Missouri, 64108, United States
Infectious Disease Associates of Central New Jersey
Somerville, New Jersey, 08876, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Dr David Kaufman
New York, New York, 10014, United States
Saint Vincent Med Ctr
Staten Island, New York, 10310, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Hershey Med Ctr / Dept of Med / Div of Hematology
Hershey, Pennsylvania, 17033, United States
Univ of Pennsylvania / Division of Infectious Diseases
Philadelphia, Pennsylvania, 19104, United States
Novum Inc
Pittsburgh, Pennsylvania, 152063817, United States
Omega Med Research
Providence, Rhode Island, 02907, United States
Med Univ of South Carolina / Div of Infect Dis
Charleston, South Carolina, 29425, United States
Dr Alfred Burnside
Columbia, South Carolina, 29206, United States
Dr Susie Sargent
Memphis, Tennessee, 38163, United States
Nelson Tebedo Health Resource Ctr
Dallas, Texas, 75219, United States
Univ of Texas Med Branch / Div of Infectious Dis
Galveston, Texas, 775550835, United States
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006, United States
Walter Gaman
Irving, Texas, 75038, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Advanced Research Management
Seattle, Washington, 981225314, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2002-08