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

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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.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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