A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.

Conditions

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HIV Infections Chickenpox

Keywords

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Herpes Zoster Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents sorivudine Chickenpox

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sorivudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Inability to take oral capsules or tolerate liquids.

Concurrent Medication:

Excluded:

* 5-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:

* 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.

Required:

* Prior acyclovir or foscarnet.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Bristol - Myers Squibb Co

Wallingford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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AI458-903

Identifier Type: -

Identifier Source: secondary_id

255A