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

• Status: Completed
• Trial end date: 1999-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection.

Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antiviral Agents; Stavudine

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.