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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002012
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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

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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

ClinicalTrials.gov Identifier: NCT00002012     History of Changes
Other Study ID Numbers: 069A
90-151ME
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: March 1993

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs