ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

This study has been completed.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00002411
  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

MedlinePlus related topics:   AIDS    AIDS Medicines   

Drug Information available for:   Zidovudine    Lamivudine    Didanosine    Stavudine    Nelfinavir    Nelfinavir Mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:   A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:   March 1998
Estimated Study Completion Date:   March 1998

  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

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

Show 32 study locations  Show 32 Study Locations

Sponsors and Collaborators
Bristol-Myers Squibb

Investigators
Principal Investigator:     . .     .    
  More Information


BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
 
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   039E, AI454-148
First Received:   November 2, 1999
Last Updated:   August 15, 2007
ClinicalTrials.gov Identifier:   NCT00002411
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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
Didanosine
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
Nelfinavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers