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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Stavudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002349

244A

AI455-029

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind