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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

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ClinicalTrials.gov Identifier: NCT00002018
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment
HIV Infections Drug: Interferon alfa-n3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources





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).
  • 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.


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): NCT00002018


Locations
United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029
Sponsors and Collaborators
Interferon Sciences

ClinicalTrials.gov Identifier: NCT00002018     History of Changes
Other Study ID Numbers: 069B
90-355ME
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1993

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

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