Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
NCT ID: NCT00002078
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Interferon alfa-n3
Eligibility Criteria
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Inclusion Criteria
* HIV-1 seropositivity.
* CD4 count \> 400/mm3.
* Eligibility for care in the military medical system.
Prior Medication:
Allowed:
* Acyclovir.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Walter Reed Army Institute of Research (WRAIR)
FED
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Purdue Frederick
INDUSTRY
Locations
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Walter Reed Army Institute of Research
Washington D.C., District of Columbia, United States
Natl Naval Med Ctr
Bethesda, Maryland, United States
Countries
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References
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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)
Other Identifiers
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082A
Identifier Type: -
Identifier Source: org_study_id