A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3

Inclusion Criteria

Concurrent Medication:

Allowed:

• Isoniazid for < grade 2 peripheral neuropathy (if patient is also taking 50 mg/day pyridoxine).
• Phenytoin for < grade 2 peripheral neuropathy.
• A 21-day course of adjuvant systemic corticosteroid therapy for moderate to severe Pneumocystis carinii pneumonia (PCP).
• Chemoprophylaxis for PCP, candidiasis, herpes simplex infection (up to 1 g acyclovir daily), and Mycobacterium tuberculosis.

Patients must have:

• HIV infection.
• CD4 count < 400 cells/mm3 within 30 days prior to study entry.

NOTE:

• Minimal Kaposi's sarcoma is allowed.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Active opportunistic infection requiring acute therapy.
• Need for maintenance therapy for cytomegalovirus infection, toxoplasmic encephalitis, or mycobacterial infection.
• Malignancy (other than minimal Kaposi's sarcoma) requiring therapy.
• Grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

• Other antiretroviral drugs, biologic response modifiers, cytotoxic chemotherapy, or investigational drugs (unless approved by the protocol chairs).
• Recombinant erythropoietin, G-CSF, or GM-CSF.
• Drugs that cause peripheral neuropathy, e.g., gold, hydralazine, nitrofurantoin, vincristine, cisplatin, disulfiram, and diethyldithiocarbamate (unless approved by the protocol chairs).

Concurrent Treatment:

Excluded:

• Radiation therapy (unless approved by the protocol chairs).

Patients with the following prior conditions are excluded:

• History of intolerance to AZT at 600 mg/day or less.
• Unexplained temperature of 38.5 degrees C persisting for 14 days or longer.
• Unexplained, chronic diarrhea defined as 3 or more stools per day persisting for 14 days or longer.

Prior Medication:

Excluded:

• Acute therapy for opportunistic infection within 14 days prior to study entry.
• Prior ddC, ddI, or IFN alfa-2a.

Active substance abuse.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety