A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Stavudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
. ., Principal Investigator, Affiliation: .
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety Study
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Bristol - Myers Squibb Co, Princeton, New Jersey 085434500, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Last updated: August 15, 2007
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