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Clinical Trials/NCT00002078
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

Sponsor
Purdue Frederick
Sponsor Class
Industry

Study Sites (4)

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