CLINICAL TRIALS PROFILE FOR ALFERON N INJECTION

All Clinical Trials for ALFERON N INJECTION

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000844 ↗	A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals. Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
NCT00002018 ↗	Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects	Completed	Interferon Sciences	N/A	1969-12-31	To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.
NCT00002078 ↗	Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection	Completed	Henry M. Jackson Foundation for the Advancement of Military Medicine	Phase 1	1969-12-31	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.
NCT00002078 ↗	Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection	Completed	Walter Reed Army Institute of Research (WRAIR)	Phase 1	1969-12-31	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.
NCT00002078 ↗	Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection	Completed	Purdue Frederick	Phase 1	1969-12-31	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.
NCT00215826 ↗	Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers	Completed	AIM ImmunoTech Inc.	Phase 2	2004-11-01	The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to determine an Alferon LDO dose level that increases or upregulates genes known to be mediators of interferon response. Secondary endpoints include the development of SARS symptomatology, rate of hospitalization, and mortality rate. In the event that no subjects with recent exposure to a person with SARS or possible SARS are available, this study will be conducted with 10 normal volunteers.
NCT00215826 ↗	Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers	Completed	Hemispherx Biopharma	Phase 2	2004-11-01	The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to determine an Alferon LDO dose level that increases or upregulates genes known to be mediators of interferon response. Secondary endpoints include the development of SARS symptomatology, rate of hospitalization, and mortality rate. In the event that no subjects with recent exposure to a person with SARS or possible SARS are available, this study will be conducted with 10 normal volunteers.

Clinical Trial Conditions for ALFERON N INJECTION

Condition Name

Condition Name for ALFERON N INJECTION
Intervention	Trials
HIV Infections	4
Severe Acute Respiratory Syndrome	1

Condition MeSH

Condition MeSH for ALFERON N INJECTION
Intervention	Trials
HIV Infections	4
Infections	1
Infection	1
Immunologic Deficiency Syndromes	1

Clinical Trial Locations for ALFERON N INJECTION

Trials by Country

Trials by Country for ALFERON N INJECTION
Location	Trials
United States	13
Hong Kong	1

Trials by US State

Trials by US State for ALFERON N INJECTION
Location	Trials
Pennsylvania	2
New York	2
District of Columbia	2
Maryland	1
Tennessee	1

Clinical Trial Progress for ALFERON N INJECTION

Clinical Trial Phase

Clinical Trial Phase for ALFERON N INJECTION
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	1
N/A	2

Clinical Trial Status

Clinical Trial Status for ALFERON N INJECTION
Clinical Trial Phase	Trials
Completed	4
Terminated	1

Clinical Trial Sponsors for ALFERON N INJECTION

Sponsor Name

Sponsor Name for ALFERON N INJECTION
Sponsor	Trials
AIM ImmunoTech Inc.	2
Hemispherx Biopharma	2
Interferon Sciences	1

Sponsor Type

Sponsor Type for ALFERON N INJECTION
Sponsor	Trials
Industry	6
Other	1
U.S. Fed	1