Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002078
- Run by
- Purdue Frederick
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- HIV-1 seropositivity.
- CD4 count > 400/mm3.
- Eligibility for care in the military medical system.
- Prior Medication:
- Allowed:
- Acyclovir.
You may not qualify if…
- 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.
Where it is running
- Walter Reed Army Institute of Research — Washington D.C., District of Columbia, United States
- Natl Naval Med Ctr — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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