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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002308
First received: November 2, 1999
Last updated: August 4, 2011
Last verified: August 2011

November 2, 1999
August 4, 2011
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002308 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Stavudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 1991
Not Provided

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002308
116B, AI455-900
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Principal Investigator: . . .
Bristol-Myers Squibb
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP