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

Conditions: HIV Infections

Summary: to determine the safety and efficacy of two doses of interferon alfa-2a ( ifn alfa-2a ) in combination with zidovudine ( azt )/zalcitabine ( ddc ) versus azt/ddc only in patients with hiv infection and cd4 count \< 400 cells/mm3. azt and ddc inhibit hiv by acting as reverse transcriptase chain terminators, while ifn alfa-2a inhibits translation of viral proteins. combining agents that act at different sites of viral replication may improve hiv inhibition and produce more effective and sustained anti-hiv effects.

azt and ddc inhibit hiv by acting as reverse transcriptase chain terminators, while ifn alfa-2a inhibits translation of viral proteins. combining agents that act at different sites of viral replication may improve hiv inhibition and produce more effective and sustained anti-hiv effects. patients are randomly assigned to one of three treatment arms to receive azt/ddc alone or combined with one of two doses of ifn alfa-2a. treatment continues for up to 12 months after enrollment of the last patient. patients are followed at 2, 4, and 8 weeks and every 8 weeks thereafter. mean duration of follow-up is expected to be 13 months.

Eligibility criteria:
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.

Keywords: zalcitabine acquired immunodeficiency syndrome aids-related complex zidovudine interferon-alpha