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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000844
First received: November 2, 1999
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Interferon alfa-n3
Drug: Interferon alfa-n1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 560
Study Completion Date: June 2002
Detailed Description:

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.

Patients are randomized to receive 6 months of Alferon LDO alone, Alferon with Veldona, Alferon with Ferimmune, or three placebos, with follow-up visits monthly.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • Symptomatic HIV infection.
  • CD4 count 50 - 350 cells/mm3.

Prior Medication:

Allowed:

  • Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry).
  • Maintenance therapy for a chronic condition.

Exclusion Criteria

Patients with the following prior condition are excluded:

  • Change in antiretroviral therapy within past 6 weeks.

Prior Medication:

Excluded:

  • Oral IFN-alpha or other immune-based therapy within the past month.
  • Therapy for any acute disease within the past week.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000844

Locations
United States, California
King - Drew Med Ctr
Los Angeles, California, United States, 90059
AIDS Community Research Consortium
Redwood City, California, United States, 94063
United States, Connecticut
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483
United States, Delaware
Med Ctr of Delaware / Wilmington Hosp
Wilmington, Delaware, United States, 19801
United States, District of Columbia
Abundant Life Clinic Foundation
Washington, District of Columbia, United States, 20019
Howard Univ Hosp
Washington, District of Columbia, United States, 20059
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, Minnesota
Univ of Minnesota Hosp
Minneapolis, Minnesota, United States, 55455
United States, New York
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Dr Barbara Justice
New York, New York, United States, 10031
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
New York Med College / Westchester County Med Ctr
Valhalla, New York, United States, 10595
United States, Pennsylvania
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Meharry Med College
Nashville, Tennessee, United States, 37208
Sponsors and Collaborators
Investigators
Study Chair: Alston B
Study Chair: Standiford H
Study Chair: Kumi J
Study Chair: Greaves W
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000844     History of Changes
Other Study ID Numbers: DATRI 022, 11727
Study First Received: November 2, 1999
Last Updated: May 21, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Adjuvants, Immunologic
Administration, Oral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Interferon-alpha

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Adjuvants, Immunologic
Interferon-alpha
Interferons
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014