Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects

Launched by INTERFERON SCIENCES · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • 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.