A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Recent HIV infection.
• • No prior antiretroviral therapy.
• • No acute opportunistic infection at study entry.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Intractable diarrhea.
• • Bilateral peripheral neuropathy.
• • Any other condition that would preclude study therapy.
• Concurrent Medication:
• Excluded:
• • Myelosuppressive, neurotoxic, or hepatotoxic drugs.
• Patients with the following prior condition are excluded:
• • History of bilateral peripheral neuropathy.
• Prior Medication:
• Excluded:
• • Prior antiretroviral therapy.
• • Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.