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).

Condition	Treatment or Intervention
HIV Infections	Drug: Nelfinavir mesylate  Drug: Lamivudine  Drug: Stavudine  Drug: Zidovudine  Drug: Didanosine

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Alabama
      Sorra Research Ctr / Med Forum, Birmingham,  Alabama,  35203,  United States
Arizona
      Body Positive, Phoenix,  Arizona,  85016,  United States
California
      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
Connecticut
      Yale New Haven Hosp / Nathan Smith Clinic, New Haven,  Connecticut,  06504,  United States
District of Columbia
      GW Med Ctr / Clinical Trials Unit, Washington,  District of Columbia,  20037,  United States
Florida
      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
Illinois
      Rush Presbyterian / ST Lukes Med Ctr, Chicago,  Illinois,  60612,  United States
      Northwestern Univ / Div of Infect Diseases, Chicago,  Illinois,  60611,  United States
Kansas
      Univ of Kansas School of Medicine / Office of Rsch, Wichita,  Kansas,  67214,  United States
Kentucky
      Ky Clinic Annex #4 / Room 205E / Speed Sort #0284, Lexington,  Kentucky,  405360226,  United States
New Hampshire
      Dartmouth-Hitchcock Med Ctr, Lebanon,  New Hampshire,  03756,  United States
New Jersey
      Infectious Disease Assoc of Central Jersey, Somerville,  New Jersey,  08876,  United States
      NJCRI, Newark,  New Jersey,  07103,  United States
New York
      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
North Carolina
      Nalle Clinic / Clinical Research Dept, Charlotte,  North Carolina,  28207,  United States
Oklahoma
      Associates in Med and Mental Health, Tulsa,  Oklahoma,  74114,  United States
Pennsylvania
      Stephen P Hauptman, Philadelphia,  Pennsylvania,  19107,  United States
South Carolina
      Med Univ of South Carolina / Div of Infect Disease, Charleston,  South Carolina,  29425,  United States
Texas
      Univ of Texas / Med Branch at Galveston, Galveston,  Texas,  775550835,  United States
      Joseph C Gathe, Houston,  Texas,  77004,  United States

Study ID Numbers:  039E; AI454-148
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002411
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08