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
Current as of December 03, 2023
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...
- Inclusion Criteria
- Concurrent Medication:
- 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.
- 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:
- 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:
- 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:
- Acute therapy for opportunistic infection within 14 days prior to study entry.
- Prior ddC, ddI, or IFN alfa-2a.
- Active substance abuse.
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Birmingham, Alabama, United States
San Diego, California, United States
Miami, Florida, United States
La Jolla, California, United States
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