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Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients

This study has been completed.

Sponsored by: Interferon Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002012
  Purpose

To conduct a parallel-group, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of an orally administered low dose interferon alfa-n3 as an immunomodulator in the treatment of mild to moderate symptomatic HIV+, AIDS-related complex (ARC) patients.


Condition Intervention
HIV Infections
Drug: Interferon alfa-n3

MedlinePlus related topics:   AIDS   

Drug Information available for:   Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind
Official Title:   Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   45

Detailed Description:

The study has been extended to offer 52 weeks of maintenance therapy after the 10 weeks of the placebo controlled period are concluded successfully.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine (AZT).

Patients must have:

  • Diagnosis of AIDS related complex (ARC).
  • Given written informed consent.
  • Been receiving a dose of = or < 600 mg/day of zidovudine (AZT) at least 90 days prior to study entry IF they are currently taking AZT.

Prior Medication:

Allowed:

  • Zidovudine (AZT) at a dose = or < 600 mg/day at least 90 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • History of AIDS-defining condition or evidence of AIDS dementia.
  • Evidence of chronic hepatitis with severe liver dysfunction, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular or psychiatric disorder that would limit the subject's ability to complete the 12 weeks of the study period.

Concurrent Medication:

Excluded:

  • Ketoconazole.
  • Trimethoprim / sulfamethoxazole (TMP/SMX).
  • Experimental medications.

Patients with the following are excluded:

  • Absolute CD4 count of < 100 or > 350 cells/mm3.
  • Any disease or disorder listed in Patient Exclusion Co-existing Conditions.
  • Unlikely or unable to comply with the requirements of the protocol.
  • Unwilling or unable to give informed consent.
  • Development of antibodies to interferon during prior interferon therapy that occurred > 3 months prior to study entry.

Prior Medication:

Excluded within 45 days of study entry:

  • Immunomodulators (e.g., BCG vaccine, isoprinosine).
  • Chemotherapy.
  • Steroids.
  • Excluded within 3 months of study entry:
  • Interferon therapy. Active IV drug abuse.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002012

Locations
United States, New York
Mount Sinai Med Ctr    
      New York, New York, United States, 10029

Sponsors and Collaborators
Interferon Sciences
  More Information


Publications:
Hassett J, Mendelsohn L. Effect of low dose oral interferon alfa-n3 (IFN) in ARC. Int Conf AIDS. 1993 Jun 6-11;9(1):494 (abstract no PO-B28-2151)
 

Study ID Numbers:   069A, 90-151ME
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002012
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Interferon Type I, Recombinant  

Study placed in the following topic categories:
Interferon-alpha
Sexually Transmitted Diseases, Viral
Interferon Type I, Recombinant
Acquired Immunodeficiency Syndrome
Interferons
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Interferon Alfa-2a
Retroviridae Infections
Interferon Alfa-2b

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on November 30, 2008




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