The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).
Inclusion Criteria
Patients must have:
Within 15 business days prior to randomization:
- CD4 cell count greater than or equal to 100 cells/mm3.
- HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
- Bilateral peripheral neuropathy.
- Intractable diarrhea.
- Proven or suspected acute hepatitis within 30 days prior to study entry.
Concurrent Medication:
Excluded:
- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
Concurrent Treatment:
Excluded:
Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
Patients with the following prior conditions are excluded:
History of acute or chronic pancreatitis.
Prior Medication:
Excluded:
- Therapy for any previous disease that may interfere with patient ability to participate in this study.
- Excluded within 14 days prior to randomization:
Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy.
- Excluded within 3 months of the start of this study or expected need at time of enrollment:
- Agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential.
- Inability to tolerate oral medication.
Prior Treatment:
Excluded:
Therapy for any previous disease that may interfere with patient ability to participate in this study.
Risk Behavior:
Excluded:
Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.
Sorra Research Ctr / Med Forum, Birmingham, Alabama 35203, United States
Body Positive, Phoenix, Arizona 85016, United States
Harbor UCLA Med Ctr / Research and Educational Institute, Torrance, California 90502, United States
UCLA Med Ctr / CARE BH-412 CHS, Los Angeles, California 90024, United States
West Los Angeles VAMC, Los Angeles, California 90073, United States
Sherman Oaks Hosp Research Institute, Sherman Oaks, California 91403, United States
Hill Top Research Inc, Fresno, California 93710, United States
AIDS Healthcare Foundation, Los Angeles, California 900276069, United States
Yale New Haven Hosp / Nathan Smith Clinic, New Haven, Connecticut 06504, United States
GW Med Ctr / Clinical Trials Unit, Washington, District of Columbia 20037, United States
Saint Josephs Hosp, Tampa, Florida 33602, United States
Hillsborough County Health Dept, Tampa, Florida 33602, United States
Med Alternatives, Fort Lauderdale, Florida 33308, United States
Specialty Med Care Ctrs of South Florida Inc, Miami, Florida 33142, United States
Urgent Care Ctr, Fort Lauderdale, Florida 33316, United States
Rush Presbyterian / ST Lukes Med Ctr, Chicago, Illinois 60612, United States
Northwestern Univ / Div of Infect Diseases, Chicago, Illinois 60611, United States
Univ of Kansas School of Medicine / Office of Rsch, Wichita, Kansas 67214, United States
Ky Clinic Annex #4 / Room 205E / Speed Sort #0284, Lexington, Kentucky 405360226, United States
Dartmouth-Hitchcock Med Ctr, Lebanon, New Hampshire 03756, United States
Infectious Disease Assoc of Central Jersey, Somerville, New Jersey 08876, United States
NJCRI, Newark, New Jersey 07103, United States
SUNY at Stony Brook / Div of Infectious Disease, Stony Brook, New York 117948153, United States
St Luke Roosevelt Hosp, New York, New York 10011, United States
UCT International, Farmingdale, New York 11735, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases), Rochester, New York 14642, United States
Nalle Clinic / Clinical Research Dept, Charlotte, North Carolina 28207, United States
Associates in Med and Mental Health, Tulsa, Oklahoma 74114, United States
Stephen P Hauptman, Philadelphia, Pennsylvania 19107, United States
Med Univ of South Carolina / Div of Infect Disease, Charleston, South Carolina 29425, United States
Univ of Texas / Med Branch at Galveston, Galveston, Texas 775550835, United States
Joseph C Gathe, Houston, Texas 77004, United States
