NCT00000844

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for not_applicable hiv-infections

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationAdjuvants, ImmunologicAdministration, OralAcquired Immunodeficiency SyndromeAIDS-Related ComplexInterferon-alpha

Interventions

Interferon alfa-n3DRUG
Interferon alfa-n1DRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

King - Drew Med Ctr

Los Angeles, California, 90059, United States

Location

AIDS Community Research Consortium

Redwood City, California, 94063, United States

Location

Yale Univ / New Haven

New Haven, Connecticut, 065102483, United States

Location

Med Ctr of Delaware / Wilmington Hosp

Wilmington, Delaware, 19801, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Abundant Life Clinic Foundation

Washington D.C., District of Columbia, 20019, United States

Location

Howard Univ Hosp

Washington D.C., District of Columbia, 20059, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

Univ of Minnesota Hosp

Minneapolis, Minnesota, 55455, United States

Location

SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, New York, 11203, United States

Location

Dr Barbara Justice

New York, New York, 10031, United States

Location

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

New York Med College / Westchester County Med Ctr

Valhalla, New York, 10595, United States

Location

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, 19104, United States

Location

Meharry Med College

Nashville, Tennessee, 37208, United States

Location

Related Publications (3)

  • Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5.

    PMID: 11363808BACKGROUND

  • Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10.

    PMID: 11364607BACKGROUND

  • Alston B, Ellenberg JH, Standiford HC, Muth K, Martinez A, Greaves W, Kumi J. A multicenter, randomized, controlled trial of three preparations of low-dose oral alpha-interferon in HIV-infected patients with CD4+ counts between 50 and 350 cells/mm(3). Division of AIDS Treatment Research Initiative (DATRI) 022 Study Group. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):348-57. doi: 10.1097/00126334-199912010-00005.

    PMID: 10634196RESULT

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Interferon Alfa-n3interferon alfa-n1

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Alston B

    STUDY CHAIR

  • Standiford H

    STUDY CHAIR

  • Kumi J

    STUDY CHAIR

  • Greaves W

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

June 1, 2002

Last Updated

November 3, 2021

Record last verified: 2021-10

Locations

US(15)