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A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients

This study has been completed.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00002207
  Purpose

The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.


Condition Intervention
HIV Infections
Drug: Stavudine
Drug: Didanosine

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Didanosine    Stavudine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Official Title:   A Randomized, Double-Blind Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination With Twice-Daily Dosing of Stavudine in HIV-Infected Subjects

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:   February 2004
Estimated Study Completion Date:   February 2004

Detailed Description:

Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4 cell count of at least 100 cells/mm3.
  • Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

  • Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
  • Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening.
  • Inability to tolerate oral medication.
  • Any other clinical condition that would preclude compliance with dosing requirements.

Patients with the following prior conditions are excluded:

  • History of acute or chronic pancreatitis.
  • Intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry.
  • Proven or suspected acute hepatitis within 30 days prior to study entry.

    1. Potent neurotoxic drugs, such as vincristine and thalidomide.

  • Other anti-HIV therapy.

    1. Prophylaxis for pneumocystis carinii pneumonia (PCP) is strongly recommended for patients with CD4 cell counts less than or equal to 200/mm3 or who have had a prior episode of PCP.

  • Immunizations recommended by ACIP for routine practice.
  • Erythropoietin and G-CSF are allowed if myelosuppression emerges on study.

    1. Any antiretroviral therapy.

  • Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.

    1. Any prior antiretroviral therapy.

  • Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.

Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002207

Locations
United States, Alabama
Clinsites / Sorra Research Ctr    
      Birmingham, Alabama, United States, 35203
United States, California
Shared Med Research Foundation    
      Tarzana, California, United States, 91356
United States, Indiana
Indiana Univ School of Medicine / Dept of Infect Dis    
      Indianapolis, Indiana, United States, 46202
United States, Michigan
Medicine Faculty Associates    
      Ypsilanti, Michigan, United States, 48197
United States, New Jersey
New Jersey Community Research Initiative    
      Newark, New Jersey, United States, 07103
ID Care Inc    
      Somerville, New Jersey, United States, 08876
United States, Oregon
Fanno Creek Clinic    
      Portland, Oregon, United States, 97219
United States, Pennsylvania
Anderson Clinical Research    
      Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas    
      Dallas, Texas, United States, 75235
Univ of Texas Med Branch    
      Galveston, Texas, United States, 775550835
Houston Clinical Research Network    
      Houston, Texas, United States, 77006
United States, Virginia
Hampton Roads Med Specialists    
      Hampton, Virginia, United States, 23666
Dr Iraj Mirshahi    
      Richmond, Virginia, United States, 23220

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
 

Publications:

Study ID Numbers:   039D, AI454-143
First Received:   November 2, 1999
Last Updated:   October 1, 2007
ClinicalTrials.gov Identifier:   NCT00002207
Health Authority:   United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Didanosine  
Drug Therapy, Combination  
Stavudine  
Reverse Transcriptase Inhibitors  

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

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

ClinicalTrials.gov processed this record on October 07, 2008




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