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

This study has been completed.
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
Henry M Jackson Foundation
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002078
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1993
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Interferon alfa-n3
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002078

Locations
United States, District of Columbia
Walter Reed Army Institute of Research
Washington, District of Columbia, United States, 20307
United States, Maryland
Natl Naval Med Ctr
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Purdue Frederick
Walter Reed Army Institute of Research (WRAIR)
Henry M Jackson Foundation
  More Information

Publications:
Skillman DR, Wagner K, Malone JL, Decker C, Paparello S, Meltzer MS. Phase 1 study of interferon alfa-N3 in asymptomatic HIV-infected persons. Int Conf AIDS. 1993 Jun 6-11;9(1):468 (abstract no PO-B26-1998)

ClinicalTrials.gov Identifier: NCT00002078     History of Changes
Other Study ID Numbers: 082A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Evaluation
Interferon-alpha

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014