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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002411
First Posted: August 31, 2001
Last Update Posted: April 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002411


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00002411     History of Changes
Other Study ID Numbers: 039E
AI454-148
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: April 25, 2011
Last Verified: April 2011

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Zidovudine
Stavudine
Didanosine
Nelfinavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites
HIV Protease Inhibitors
Protease Inhibitors


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