Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
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ClinicalTrials.gov Identifier: NCT00002078
Recruitment Status :
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Walter Reed Army Institute of Research (WRAIR)
Henry M. Jackson Foundation for the Advancement of Military Medicine
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
CD4 count > 400/mm3.
Eligibility for care in the military medical system.
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.
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.
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.
Excluded within 5 days prior to study entry:
Excluded within 45 days prior to study entry:
Other immune modulators.
Excluded within 3 months prior to study entry:
Any form of interferon.
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.