ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

This study has been completed.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00002349
  Purpose

To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection.

Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.


Condition Intervention
HIV Infections
Drug: Stavudine

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Stavudine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:   A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:   40

Detailed Description:

Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.

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

Criteria

Inclusion Criteria

Patients must have:

  • Recent HIV infection.
  • No prior antiretroviral therapy.
  • No acute opportunistic infection at study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Intractable diarrhea.
  • Bilateral peripheral neuropathy.
  • Any other condition that would preclude study therapy.

Concurrent Medication:

Excluded:

  • Myelosuppressive, neurotoxic, or hepatotoxic drugs.

Patients with the following prior condition are excluded:

History of bilateral peripheral neuropathy.

Prior Medication:

Excluded:

  • Prior antiretroviral therapy.
  • Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002349

Locations
United States, California
San Diego Naval Hosp    
      San Diego, California, United States, 921345000
United States, Virginia
Naval Med Ctr    
      Portsmouth, Virginia, United States, 237085100
United States, Washington
Northwest Med Ctr    
      Seattle, Washington, United States, 98122

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:
Katlama C, Molina JM, Rozenbaum W, Valantin MA, Modai J, Chauveau E, Ngo Van P, Gres JJ. Stavudine ( D4T ) in HIV infected patients with CD4 less than 350/mm3: results of a double-blind randomized placebo controlled study. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:89
 

Study ID Numbers:   244A, AI455-029
First Received:   November 2, 1999
Last Updated:   August 15, 2007
ClinicalTrials.gov Identifier:   NCT00002349
Health Authority:   United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
AIDS-Related Complex  
Stavudine  

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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
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 10, 2008




Links to all studies - primarily for crawlers