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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.

Sponsors and Collaborators: Purdue Frederick
Walter Reed Army Institute of Research (WRAIR)
Henry M Jackson Foundation
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002078
  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 I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

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

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)
 

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

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

Study placed in the following topic categories:
Interferon-alpha
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Interferons
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Interferon Alfa-2a
Interferon Alfa-2b
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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