The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
Completed · Phase 3
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002368
- Run by
- Boehringer Ingelheim
- People needed
- 2000
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
Where it is running
- 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
- Drug Research and Analysis Corp — Montgomery, Alabama, United States
Full record on ClinicalTrials.gov
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