NCT00002078

Brief Summary

To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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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
Last Updated

June 24, 2005

Status Verified

November 1, 1993

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug EvaluationInterferon-alpha

Interventions

Interferon alfa-n3DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • HIV-1 seropositivity.
  • CD4 count \> 400/mm3.
  • Eligibility for care in the military medical system.
  • Prior Medication:
  • Allowed:
  • Acyclovir.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
  • Evidence of AIDS dementia.
  • Chronic hepatitis with severe liver dysfunction.
  • Active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, or psychiatric disorder that would limit ability to complete the study.
  • Hemophilia.
  • Co-existent disease likely to result in death within the next 2 years.
  • Known hypersensitivity to human interferon alpha.
  • Known anaphylactic hypersensitivity to mouse immunoglobulin (IgG), egg protein, or neomycin.
  • Concurrent Medication:
  • Excluded:
  • Any other concurrent experimental medications.
  • Patients with the following prior conditions are excluded:
  • History of AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Walter Reed Army Institute of Research

Washington D.C., District of Columbia, 20307, United States

Location

Natl Naval Med Ctr

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

  • Skillman DR, Wagner K, Malone JL, Decker C, Paparello S, Meltzer MS. Phase 1 study of interferon alfa-N3 in asymptomatic HIV-infected persons. Int Conf AIDS. 1993 Jun 6-11;9(1):468 (abstract no PO-B26-1998)

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Interferon Alfa-n3

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1993-11

Locations

US(2)