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.
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.
Drug Research and Analysis Corp, Montgomery, Alabama 36104, United States
Harbor - UCLA Med Ctr, Torrance, California 90502, United States
Dr G Michael Wool, Los Angeles, California 90067, United States
AIDS Community Research Consortium, Redwood City, California 94063, 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
San Francisco Gen Hosp / UCSF AIDS Program, San Francisco, California 94110, United States
ViRx Inc, San Francisco, California 94109, United States
Dr Miguel Mogyoros / Clinical Research Dept, Denver, Colorado 80205, United States
Denver Public Health, Denver, Colorado 80204, United States
Infectious Disease Specialists, Colorado Springs, Colorado 80903, United States
Wilmington Hosp, Wilmington, Delaware 19801, United States
Novum Inc, Washington, District of Columbia 20037, United States
Goodgame Med Group, Maitland, Florida 32751, United States
Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States
North Broward Hosp District, Fort Lauderdale, Florida 33316, United States
Palm Beach Research Ctr, West Palm Beach, Florida 33409, United States
P Andrew Coley, Jacksonville, Florida 32216, United States
McGregor Clinic / Lee County Public Health Unit, Fort Myers, Florida 33901, United States
Anthony LaMarca, Fort Lauderdale, Florida 33308, United States
Dr Robert Schwartz, Fort Myers, Florida 33901, United States
Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis, Chicago, Illinois 60612, United States
Northwestern Univ / Division of Infectious Diseases, Chicago, Illinois 60611, United States
Dr John Pottage, Chicago, Illinois 60610, United States
Indiana Univ Med School, Indianapolis, Indiana 46202, United States
Univ of Iowa, Iowa City, Iowa 52242, United States
Dr Daniel H Gervich, Des Moines, Iowa 50325, 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
Saint Vincent Med Ctr, Staten Island, New York 10310, United States
Dr David Kaufman, New York, New York 10014, United States
Associates in Med and Mental Health, Tulsa, Oklahoma 74114, United States
The Research and Education Group, Portland, Oregon 97210, United States
Novum Inc, Pittsburgh, Pennsylvania 152063817, 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
Omega Med Research, Providence, Rhode Island 02907, United States
Dr Alfred Burnside, Columbia, South Carolina 29206, United States
Med Univ of South Carolina / Div of Infect Dis, Charleston, South Carolina 29425, United States
Dr Susie Sargent, Memphis, Tennessee 38163, United States
Walter Gaman, Irving, Texas 75038, United States
Houston Clinical Research Network / Div of Montrose Clinic, Houston, Texas 77006, United States
Univ of Texas Med Branch / Div of Infectious Dis, Galveston, Texas 775550835, United States
Nelson Tebedo Health Resource Ctr, Dallas, Texas 75219, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States
Advanced Research Management, Seattle, Washington 981225314, United States
