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.

Condition	Treatment or Intervention
HIV Infections	Drug: Stavudine

Further Study Details: 

Expected Total Enrollment:  40

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      San Diego Naval Hosp, San Diego,  California,  921345000,  United States
Virginia
      Naval Med Ctr, Portsmouth,  Virginia,  237085100,  United States
Washington
      Northwest Med Ctr, Seattle,  Washington,  98122,  United States

Study ID Numbers:  244A; AI455-029
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002349
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08