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

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Nevirapine, Lamivudine, Disease Progression, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Eligibility 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.
Sites / Locations
- Drug Research and Analysis Corp
- Dr G Michael Wool
- UCLA School of Medicine / Ctr for Research and Education
- AIDS Research Ctr / Palo Alto VA Health Care System
- AIDS Community Research Consortium
- ViRx Inc
- San Francisco Gen Hosp / UCSF AIDS Program
- Harbor - UCLA Med Ctr
- Infectious Disease Specialists
- Denver Public Health
- Dr Miguel Mogyoros / Clinical Research Dept
- Wilmington Hosp
- Novum Inc
- Anthony LaMarca
- North Broward Hosp District
- Dr Robert Schwartz
- McGregor Clinic / Lee County Public Health Unit
- P Andrew Coley
- Goodgame Med Group
- Infectious Disease Research Institute Inc
- Palm Beach Research Ctr
- Dr John Pottage
- Northwestern Univ / Division of Infectious Diseases
- Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
- Indiana Univ Med School
- Dr Daniel H Gervich
- Univ of Iowa
- Univ of Kentucky Med Cntr / Dept of Med / Div of ID
- Med Research Ctr
- New England Med Ctr
- Beth Israel Hosp / Virology Research Clinic
- New England Deaconess Hosp
- International Medicine and Infectious Disease
- Trinity Lutheran Hosp / HIV Program
- Infectious Disease Associates of Central New Jersey
- SUNY / Erie County Med Ctr at Buffalo
- Dr David Kaufman
- Saint Vincent Med Ctr
- Associates in Med and Mental Health
- The Research and Education Group
- Hershey Med Ctr / Dept of Med / Div of Hematology
- Univ of Pennsylvania / Division of Infectious Diseases
- Novum Inc
- Omega Med Research
- Med Univ of South Carolina / Div of Infect Dis
- Dr Alfred Burnside
- Dr Susie Sargent
- Nelson Tebedo Health Resource Ctr
- Univ of Texas Med Branch / Div of Infectious Dis
- Houston Clinical Research Network / Div of Montrose Clinic
- Walter Gaman
- Hampton Roads Med Specialists
- Advanced Research Management