Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

HIV Infections Clinical Trial

Official title:

Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002078
• Other study ID #: 082A
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 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 determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients must have:

• HIV-1 seropositivity.

• CD4 count > 400/mm3.

• Eligibility for care in the military medical system.

Prior Medication:

Allowed:

• Acyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).

• Evidence of AIDS dementia.

• Chronic hepatitis with severe liver dysfunction.

• Active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, or psychiatric disorder that would limit ability to complete the study.

• Hemophilia.

• Co-existent disease likely to result in death within the next 2 years.

• Known hypersensitivity to human interferon alpha.

• Known anaphylactic hypersensitivity to mouse immunoglobulin (IgG), egg protein, or neomycin.

Concurrent Medication:

Excluded:

• Any other concurrent experimental medications.

Patients with the following prior conditions are excluded:

• History of AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).

• Evidence of chronic hepatitis with severe liver dysfunction.

Prior Medication:

Excluded within 5 days prior to study entry:

• Immunosuppressive agents.

• Chemotherapy.

• Steroids.

Excluded within 45 days prior to study entry:

• BCG vaccine.

• Isoprinosine.

• Other immune modulators.

Excluded within 3 months prior to study entry:

• Any form of interferon.

• Antiviral therapy.

• Immunoregulatory therapy (other than acyclovir).

1. Active drug abuse (narcotic or alcohol abuse documented within the past 6 months).

• Unlikely or unable to comply with the requirements of the protocol.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• Interferon alfa-n3

Locations

Country	Name	City	State
United States	Natl Naval Med Ctr	Bethesda	Maryland
United States	Walter Reed Army Institute of Research	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Purdue Frederick	Henry M. Jackson Foundation for the Advancement of Military Medicine, Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Skillman DR, Wagner K, Malone JL, Decker C, Paparello S, Meltzer MS. Phase 1 study of interferon alfa-N3 in asymptomatic HIV-infected persons. Int Conf AIDS. 1993 Jun 6-11;9(1):468 (abstract no PO-B26-1998)