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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Interferon alfa-n3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon alfa-n3|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interferon Type I