Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Seropositivity to HIV-1 by ELISA and Western blot.
At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
Written informed consent.
If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.
Patients with the following conditions or symptoms are excluded:
Major active opportunistic infection requiring active care within 2 weeks of study entry.
Evidence of chronic hepatitis with severe liver dysfunction:
albumin < 2 g/dl and SGOT or SGPT > 5 x upper limit of normal prothrombin time > 1.5 x upper limit of normal).
Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
Transfusion dependency defined as requiring > 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.
Experimental medications other than didanosine (ddI).
Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.
Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).
Patients with the following are excluded:
Asymptomatic at study entry.
Presence of antibodies to interferon due to prior therapy.
Hospitalization within 2 weeks of study entry.
Unwilling or unable to give informed consent.
Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.
Unlikely or unable to comply with the requirements of the protocol.