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Clinical Trials

MainTitle

A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs

This study has been completed
Sponsor
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT00002308

First received: November 2, 1999
Last updated: August 4, 2011
Last Verified: August 2011
History of Changes
Purpose

Purpose

To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.

Condition Intervention
HIV Infections

Drug : Stavudine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Blinded Evaluation of Two Doses of Stavudine (2',3'-Didehydro-2',3'-Dideoxythymidine; d4T) to Make Treatment Available to Severely Immunocompromised Patients With HIV Infection Who Have Failed or Are Intolerant of Alternative Antiretroviral Therapy

Further study details as provided by Bristol-Myers Squibb:

Study Completion Date: November 1991

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
Patients must have:

  • HIV positivity with CD4 count < 300 cells/mm3.
  • Intolerance to or failure on approved antiretroviral therapy.
  • Ability to provide informed consent (of parent or guardian if appropriate).

  • NOTE:
  • Incarcerated persons may be eligible to participate.

  • Exclusion Criteria
    Co-existing Condition:
    Patients with the following symptoms or conditions are excluded:
  • Grade 2 or worse disease-related peripheral neuropathy.
  • Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI).
  • Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment.
  • Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol).

  • Strongly discouraged:
  • AZT, ddI, ddC, and other antiretroviral agents.

contacts and locations

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 ClinicalTrials.gov identifier: NCT00002308

Locations

United States, New Jersey
Bristol - Myers Squibb Co
Princeton, New Jersey, United States, 085434500

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Principal Investigator: . .
More Information

More Information

Additional Information:

BMS Clinical Trials Disclosure

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT00002308   History of Changes  
Other Study ID Numbers: 116B  
  AI455-900  
Study First Received: November 2, 1999  
Last Updated: August 4, 2011  

Keywords provided by Bristol-Myers Squibb:

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Stavudine

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Stavudine

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.