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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002018
• Other study ID #: 069B
• Secondary ID: 90-355ME
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Interferon alfa-n3

Locations

Country	Name	City	State
United States	Mount Sinai Med Ctr	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Interferon Sciences

Country where clinical trial is conducted

United States,