Expired Study
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New York, New York 10029


Purpose:

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.


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.


NCT ID:

NCT00002018


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

New York, New York 10029
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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