A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • AZT.
• Patients must have:
• • Documented HIV infection as determined by a positive ELISA and/or Western blot.
• • Absolute CD4 count of 100 - 500 cells/mm3 within 90 days prior to registration OR a CD4 count of 50 - 99 cells/mm3 within 30 days prior to registration.
• • Prior zidovudine therapy for at least 6 months and currently tolerating at least 500 mg daily.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• • Newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at time of enrollment.
• • Need for chronic systemic therapy at time of enrollment.
• • Intractable diarrhea.
• • Signs or symptoms of bilateral peripheral neuropathy at time of screening.
• • Demonstrated intolerance to zidovudine therapy.
• • Any other clinical conditions that would render the patient unsuitable for study or unable to comply with the dosing requirements.
• Concurrent Medication:
• Excluded:
• • Chronic systemic therapy with agents likely to suppress bone marrow, cause neurotoxicity, or create hepatic dysfunction.
• Patients with the following prior conditions are excluded:
• • Prior history of bilateral peripheral neuropathy.
• • Demonstrated intolerance to zidovudine therapy.
• Prior Medication:
• Excluded:
• • Prior d4T, ddI, or ddC.
• • Other investigational antiretroviral drugs (e.g., AZddU, Al 721, interferon, or immunomodulating drugs within 1 month prior to study entry or ribavirin within 3 months prior to study entry).
• • Prior myelosuppressive, neurotoxic, or cytotoxic anticancer therapy within 3 months prior to study entry.
• • Any prior therapy that would render the patient unsuitable for study or unable to comply with dosing requirements.
• Required:
• • At least 6 months of prior AZT and currently tolerating at least 500 mg daily, with the last dose received no more than 7 days prior to study entry.

Trial Officials