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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Frederick
• Collaborators: Henry M. Jackson Foundation for the Advancement of Military Medicine; Walter Reed Army Institute of Research (WRAIR)
• Treatments: Interferon-alpha; Interferons

Criteria

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.