Search / Trial NCT00002078

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

Launched by PURDUE FREDERICK · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Drug Evaluation Interferon Alpha

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Purdue Frederick

Purdue Frederick is a leading biopharmaceutical company dedicated to the development and commercialization of innovative therapies for the treatment of complex diseases. With a strong commitment to enhancing patient outcomes, Purdue Frederick leverages cutting-edge research and state-of-the-art technology to advance its clinical trials. The organization prioritizes collaboration with healthcare professionals, regulatory bodies, and patient communities to ensure the highest standards of safety and efficacy in its drug development processes. Through a robust pipeline of investigational products, Purdue Frederick aims to address unmet medical needs and improve the quality of life for patients worldwide.

Locations

Bethesda, Maryland, United States

Washington, District Of Columbia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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