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

Interferon Sciences

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Interferon alfa-n3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002018

90-355ME

069B

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.