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

• Status: Completed
• Trial end date: 1995-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Glaxo Wellcome; Hoffmann-La Roche
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Zalcitabine; Zidovudine

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.