NCT00002358

Brief Summary

To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

October 2, 2007

Status Verified

October 1, 2007

First QC Date

November 2, 1999

Last Update Submit

October 1, 2007

Conditions

HIV InfectionsChickenpox

Keywords

Herpes ZosterAcquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral AgentssorivudineChickenpox

Interventions

SorivudineDRUG

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients must have:
  • HIV infection.
  • Cutaneous, visceral, or ocular varicella-zoster viral infection.
  • Refractory or intolerant to acyclovir or foscarnet therapy.
  • Consent of parent or guardian.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Inability to take oral capsules or tolerate liquids.
  • Concurrent Medication:
  • Excluded:
  • flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid.
  • Patients with the following prior condition are excluded:
  • History of immediate hypersensitivity to nucleoside analogues.
  • Prior Medication:
  • Excluded:
  • flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.
  • Required:
  • Prior acyclovir or foscarnet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol - Myers Squibb Co

Wallingford, Connecticut, 06492, United States

Location

MeSH Terms

Conditions

HIV InfectionsChickenpoxHerpes ZosterAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

sorivudine

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

October 2, 2007

Record last verified: 2007-10

Locations

US(1)