NCT00002078CompletedPhase 1
Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
Purdue Frederick4 sites in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Locations
- 4
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have:
- •HIV-1 seropositivity.
- •CD4 count > 400/mm
- •Eligibility for care in the military medical system.
- •Prior Medication:
- •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:
- •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.
Investigators
Study Sites (4)
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