A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00002411

Run by

Bristol-Myers Squibb

Starts

1998-03-01

Expected to finish

1999-09-01

Last updated by the study team

2011-04-25

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Sorra Research Ctr / Med Forum — Birmingham, Alabama, United States
• Body Positive — Phoenix, Arizona, United States
• Hill Top Research Inc — Fresno, California, United States
• UCLA Med Ctr / CARE BH-412 CHS — Los Angeles, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• West Los Angeles VAMC — Los Angeles, California, United States
• Sherman Oaks Hosp Research Institute — Sherman Oaks, California, United States
• Harbor UCLA Med Ctr / Research and Educational Institute — Torrance, California, United States
• Yale New Haven Hosp / Nathan Smith Clinic — New Haven, Connecticut, United States
• GW Med Ctr / Clinical Trials Unit — Washington D.C., District of Columbia, United States
• Med Alternatives — Fort Lauderdale, Florida, United States
• Urgent Care Ctr — Fort Lauderdale, Florida, United States
• Specialty Med Care Ctrs of South Florida Inc — Miami, Florida, United States
• Hillsborough County Health Dept — Tampa, Florida, United States
• Saint Josephs Hosp — Tampa, Florida, United States
• Northwestern Univ / Div of Infect Diseases — Chicago, Illinois, United States
• Rush Presbyterian / ST Lukes Med Ctr — Chicago, Illinois, United States
• Univ of Kansas School of Medicine / Office of Rsch — Wichita, Kansas, United States
• Ky Clinic Annex #4 / Room 205E / Speed Sort #0284 — Lexington, Kentucky, United States
• Dartmouth-Hitchcock Med Ctr — Lebanon, New Hampshire, United States
• NJCRI — Newark, New Jersey, United States
• Infectious Disease Assoc of Central Jersey — Somerville, New Jersey, United States
• UCT International — Farmingdale, New York, United States
• St Luke Roosevelt Hosp — New York, New York, United States
• St Mary's Hosp (Univ of Rochester/Infectious Diseases) — Rochester, New York, United States

Full record on ClinicalTrials.gov

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