HIV Infections
Conditions
Keywords
Zalcitabine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Interferon-alpha
Brief 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.
Detailed description
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.
Interventions
Sponsors
Hoffmann-La Roche
Glaxo Wellcome
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed