Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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)

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

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:


- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.

Concurrent Treatment:


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:


  • 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:


Therapy for any previous disease that may interfere with patient ability to participate in this study.

Risk Behavior:


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 identifier: NCT00002411

  Show 32 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Principal Investigator: . . .
  More Information

Additional Information:
No publications provided 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:
Drug Therapy, Combination
RNA, Viral
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on February 25, 2015