The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

Inclusion Criteria

Concurrent Medication:

Allowed:

• Antibiotics for bacterial infections as clinically indicated.
• Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively.
• Antipyretics.
• Analgesics.
• Allergy medications.
• Oral contraceptives.
• Nonprescription medications such as vitamins or herbal therapies.

Concurrent Treatment:

Allowed:

• Radiation therapy to local lesion only.
• Acupuncture.

Patients must have:

• HIV seropositivity.
• CD4 count >= 550 cells/mm3.
• No ARC or AIDS conditions by CDC criteria.
• Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Presence of factors predisposing to pancreatitis such as active alcoholism.
• Other medical conditions that would interfere with study compliance.

Concurrent Medication:

Excluded:

• Other antiretrovirals or systemic immunomodulators.
• Systemic corticosteroids.
• Systemic cytotoxic chemotherapy.
• Intravenous pentamidine.

Concurrent Treatment:

Excluded:

• Radiation therapy except to local lesion.

Patients with the following prior conditions are excluded:

• History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month.
• History of grade 2 or worse peripheral neuropathy.
• History of pancreatitis.
• Bacterial infection requiring antibiotics within 14 days prior to study entry.

Prior Medication:

Excluded:

• Prior HIV therapy with antiretrovirals or systemic immunomodulators.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

• Transfusion.

Active substance abuse or alcoholism.