HIV Infections
Conditions
Keywords
Interferon Type I
Brief summary
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.
Interventions
Sponsors
Interferon Sciences
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed