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

A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Lamivudine; Drug: Stavudine; Drug: Zidovudine; Drug: Didanosine; Drug: Nelfinavir mesylate

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35203
      • Sorra Research Ctr / Med Forum
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Body Positive
  • California
    • Fresno, California, United States, 93710
      • Hill Top Research Inc
    • Los Angeles, California, United States, 900276069
      • AIDS Healthcare Foundation
    • Los Angeles, California, United States, 90024
      • UCLA Med Ctr / CARE BH-412 CHS
    • Los Angeles, California, United States, 90073
      • West Los Angeles VAMC
    • Sherman Oaks, California, United States, 91403
      • Sherman Oaks Hosp Research Institute
    • Torrance, California, United States, 90502
      • Harbor UCLA Med Ctr / Research and Educational Institute
  • Connecticut
    • New Haven, Connecticut, United States, 06504
      • Yale New Haven Hosp / Nathan Smith Clinic
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • GW Med Ctr / Clinical Trials Unit
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Med Alternatives
    • Fort Lauderdale, Florida, United States, 33316
      • Urgent Care Ctr
    • Miami, Florida, United States, 33142
      • Specialty Med Care Ctrs of South Florida Inc
    • Tampa, Florida, United States, 33602
      • Hillsborough County Health Dept
    • Tampa, Florida, United States, 33602
      • Saint Josephs Hosp
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univ / Div of Infect Diseases
    • Chicago, Illinois, United States, 60612
      • Rush Presbyterian / ST Lukes Med Ctr
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Univ of Kansas School of Medicine / Office of Rsch
  • Kentucky
    • Lexington, Kentucky, United States, 405360226
      • Ky Clinic Annex #4 / Room 205E / Speed Sort #0284
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Med Ctr
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • NJCRI
    • Somerville, New Jersey, United States, 08876
      • Infectious Disease Assoc of Central Jersey
  • New York
    • Farmingdale, New York, United States, 11735
      • UCT International
    • New York, New York, United States, 10011
      • St Luke Roosevelt Hosp
    • Rochester, New York, United States, 14642
      • St Mary's Hosp (Univ of Rochester/Infectious Diseases)
    • Stony Brook, New York, United States, 117948153
      • SUNY at Stony Brook / Div of Infectious Disease
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Nalle Clinic / Clinical Research Dept
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74114
      • Associates in Med and Mental Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Stephen P Hauptman
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Med Univ of South Carolina / Div of Infect Disease
  • Texas
    • Galveston, Texas, United States, 775550835
      • Univ of Texas / Med Branch at Galveston
    • Houston, Texas, United States, 77004
      • Joseph C Gathe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: March 1, 1998
• Primary Completion (Actual): September 1, 1999
• Study Completion (Actual): September 1, 1999

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): April 25, 2011
• Last Update Submitted That Met QC Criteria: April 13, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Anti-HIV Agents; HIV-1; Stavudine; Lamivudine; RNA, Viral; Viral Load; Didanosine; Zidovudine; Nelfinavir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Lamivudine; Zidovudine; Stavudine; Didanosine; Nelfinavir
• Other Study ID Numbers: 039E; AI454-148