A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs
NCT ID: NCT00002308
Last Updated: 2011-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
1991-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Stavudine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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Bristol - Myers Squibb Co
Princeton, New Jersey, United States
Countries
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Other Identifiers
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AI455-900
Identifier Type: -
Identifier Source: secondary_id
116B
Identifier Type: -
Identifier Source: org_study_id
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