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

Purdue Pharma

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Interferon alfa-n3

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT00002078

082A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.