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

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.

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.