A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients

Inclusion Criteria

Patients must have:

• HIV infection, as documented by a licensed ELISA that is confirmed either by Western blot, positive HIV culture, positive HIV antigen, positive plasma HIV RNA, or a second antibody test positive by a method other than ELISA.
• CD4 cell count of at least 100 cells/mm3 within 30 days of study entry.
• Over 500 HIV-1 RNA copies/ml as measured by the Roche Amplicor or Ultra Sensitive Assay within 30 days of study entry.
• Treatment-experienced patients must have documented HIV RNA values of less than or equal to 100,000 copies/ml within 30 days of study entry.

Prior Treatment:

Excluded:

Acute therapy for an infection or other medical illness. Acute therapy must have been completed 14 days prior to the time of study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Malignancy requiring systemic therapy.

Patients with the following prior conditions are excluded:

• History of acute or chronic pancreatitis.
• History of generalized peripheral neuropathy.
• Inability to tolerate ddI at 200-400 mg/day or d4T at 60-80 mg/day. For purposes of this study, intolerance will be defined as the same recurrent toxicities requiring dose interruptions and dose reductions or permanent discontinuation of the drugs (other than Grade 3 or 4 anemia).

Prior Medication:

Excluded:

Antiretroviral therapy. If antiretroviral-experienced, no prior NNRTI's or HU and no more than 12 weeks experience with ddI and/or d4T. Protease inhibitor experience is allowed. Experienced patients must be on a stable antiretroviral therapy 30 days prior to study screening and continue this regimen until study entry.

Risk Behavior:

Excluded:

Current ethanol abuse by personal history or a report from a primary physician.