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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002411
First received: November 2, 1999
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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 Intervention
HIV Infections
Drug: Nelfinavir mesylate
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Drug: Didanosine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: March 1998
Study Completion Date: September 1999
Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002411

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002411     History of Changes
Other Study ID Numbers: 039E, AI454-148
Study First Received: November 2, 1999
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV-1
Didanosine
Drug Therapy, Combination
Zidovudine
Stavudine
Lamivudine
RNA, Viral
Nelfinavir
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Zidovudine
Stavudine
Lamivudine
Nelfinavir
Anti-HIV Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014