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Home > "P" Clinical Trials Conditions > Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection  Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): Purdue Frederick , Walter Reed Army Institute of Research (WRAIR),Henry M Jackson Foundation
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Walter Reed Army Institute of Research
Washington D.C., District of Columbia, 20307
United States
Natl Naval Med Ctr
Bethesda, Maryland, 20889
United States
Additional Information:
Study ID Numbers: 082A;
Study Start Date:
Record last reviewed: November 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002078
Other Hiv Infections Studies:
1. A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
2. A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
3. HIV Expression in Patients with Low Viral Load on Highly Active Antiretroviral Therapy (HAART)
4. Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
5. A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush
Related Studies:
Other HIV Infections Clinical Trials
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Other Washington D.C. Clinical Trials
Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
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