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Sponsors and Collaborators: |
Purdue Frederick Walter Reed Army Institute of Research (WRAIR) Henry M Jackson Foundation |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002078 |
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 |
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HIV Infections |
Drug: Interferon alfa-n3 |
Phase I |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within 5 days prior to study entry:
Excluded within 45 days prior to study entry:
Excluded within 3 months prior to study entry:
Immunoregulatory therapy (other than acyclovir).
1. Active drug abuse (narcotic or alcohol abuse documented within the past 6 months).
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 |
Study ID Numbers: | 082A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002078 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Evaluation Interferon-alpha |
Interferon-alpha Sexually Transmitted Diseases, Viral Immunologic Factors Acquired Immunodeficiency Syndrome Interferons Antiviral Agents Angiogenesis Inhibitors |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Interferon Alfa-2a Retroviridae Infections |
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Infection Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections Interferon-alpha RNA Virus Infections |
Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Interferons Antiviral Agents Angiogenesis Inhibitors Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Interferon Alfa-2a |