The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
NCT ID: NCT00002368
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2000 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PARALLEL
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nevirapine
Lamivudine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Drug Research and Analysis Corp
Montgomery, Alabama, United States
Dr G Michael Wool
Los Angeles, California, United States
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, United States
AIDS Research Ctr / Palo Alto VA Health Care System
Palo Alto, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
ViRx Inc
San Francisco, California, United States
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Infectious Disease Specialists
Colorado Springs, Colorado, United States
Denver Public Health
Denver, Colorado, United States
Dr Miguel Mogyoros / Clinical Research Dept
Denver, Colorado, United States
Wilmington Hosp
Wilmington, Delaware, United States
Novum Inc
Washington D.C., District of Columbia, United States
Anthony LaMarca
Fort Lauderdale, Florida, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Dr Robert Schwartz
Fort Myers, Florida, United States
McGregor Clinic / Lee County Public Health Unit
Fort Myers, Florida, United States
P Andrew Coley
Jacksonville, Florida, United States
Goodgame Med Group
Maitland, Florida, United States
Infectious Disease Research Institute Inc
Tampa, Florida, United States
Palm Beach Research Ctr
West Palm Beach, Florida, United States
Dr John Pottage
Chicago, Illinois, United States
Northwestern Univ / Division of Infectious Diseases
Chicago, Illinois, United States
Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
Chicago, Illinois, United States
Indiana Univ Med School
Indianapolis, Indiana, United States
Dr Daniel H Gervich
Des Moines, Iowa, United States
Univ of Iowa
Iowa City, Iowa, United States
Univ of Kentucky Med Cntr / Dept of Med / Div of ID
Lexington, Kentucky, United States
Med Research Ctr
New Orleans, Louisiana, United States
New England Med Ctr
Boston, Massachusetts, United States
Beth Israel Hosp / Virology Research Clinic
Boston, Massachusetts, United States
New England Deaconess Hosp
Boston, Massachusetts, United States
International Medicine and Infectious Disease
Minneapolis, Minnesota, United States
Trinity Lutheran Hosp / HIV Program
Kansas City, Missouri, United States
Infectious Disease Associates of Central New Jersey
Somerville, New Jersey, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Dr David Kaufman
New York, New York, United States
Saint Vincent Med Ctr
Staten Island, New York, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, United States
The Research and Education Group
Portland, Oregon, United States
Hershey Med Ctr / Dept of Med / Div of Hematology
Hershey, Pennsylvania, United States
Univ of Pennsylvania / Division of Infectious Diseases
Philadelphia, Pennsylvania, United States
Novum Inc
Pittsburgh, Pennsylvania, United States
Omega Med Research
Providence, Rhode Island, United States
Med Univ of South Carolina / Div of Infect Dis
Charleston, South Carolina, United States
Dr Alfred Burnside
Columbia, South Carolina, United States
Dr Susie Sargent
Memphis, Tennessee, United States
Nelson Tebedo Health Resource Ctr
Dallas, Texas, United States
Univ of Texas Med Branch / Div of Infectious Dis
Galveston, Texas, United States
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, United States
Walter Gaman
Irving, Texas, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Advanced Research Management
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1100.1090
Identifier Type: -
Identifier Source: secondary_id
200E
Identifier Type: -
Identifier Source: org_study_id