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Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects

This study has been completed.

Sponsored by: Interferon Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002018
  Purpose

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.


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, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects

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

Estimated Enrollment:   60

  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).
  • Didanosine (ddI)

Patients must have:

  • Seropositivity to HIV-1 by ELISA and Western blot.
  • At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
  • Written informed consent.
  • If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.

Prior Medication:

Allowed:

  • Zidovudine (AZT).
  • Didanosine (ddI)

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Major active opportunistic infection requiring active care within 2 weeks of study entry.
  • Evidence of chronic hepatitis with severe liver dysfunction:
  • albumin < 2 g/dl and SGOT or SGPT > 5 x upper limit of normal prothrombin time > 1.5 x upper limit of normal).
  • Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
  • Transfusion dependency defined as requiring > 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.

Concurrent Medication:

Excluded:

  • Experimental medications other than didanosine (ddI).
  • Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.
  • Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).

Patients with the following are excluded:

  • Asymptomatic at study entry.
  • Presence of antibodies to interferon due to prior therapy.
  • Hospitalization within 2 weeks of study entry.
  • Transfusion dependency.
  • Unwilling or unable to give informed consent.
  • Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.
  • Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 6 weeks of study entry:

  • Interferons.
  • Excluded within 45 days of study entry:
  • Immunosuppressive agents.
  • Chemotherapy.
  • Steroids.
  • Immunomodulators.
  • Isoprinosine.
  • BCG vaccine.

Prior Treatment:

Excluded within 2 weeks of study entry:

  • Hospitalization.

Active intravenous (IV) drug abuse.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002018

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

Sponsors and Collaborators
Interferon Sciences
  More Information


Study ID Numbers:   069B, 90-355ME
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002018
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Interferon Type I  

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

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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