To conduct a double-blind, randomized, dose ranging study of an orally administered low dose
interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.
Inclusion Criteria
Concurrent Medication:
Allowed:
- Zidovudine (AZT).
- Didanosine (ddI)
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.
Prior Medication:
Allowed:
- Zidovudine (AZT).
- Didanosine (ddI)
Exclusion Criteria
Co-existing Condition:
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.
Concurrent Medication:
Excluded:
- 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.
- Transfusion dependency.
- 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.
Prior Medication:
Excluded within 6 weeks of study entry:
- Interferons.
- Excluded within 45 days of study entry:
- Immunosuppressive agents.
- Chemotherapy.
- Steroids.
- Immunomodulators.
- Isoprinosine.
- BCG vaccine.
Prior Treatment:
Excluded within 2 weeks of study entry:
- Hospitalization.
Active intravenous (IV) drug abuse.
