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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 fol...

Gender

ALL

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.