Wallingford, Connecticut 06492

  • Chickenpox

Purpose:

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.


Study summary:

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


Criteria:

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.


Study is Available At:


Original ID:

255A


NCT ID:

NCT00002358


Secondary ID:

AI458-903


Study Acronym:


Brief Title:

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


Official Title:

Open-Label BV-araU Treatment of Pediatric HIV-Infected Patients With Cutaneous, Visceral, or Ocular Varicella-Zoster Viral Disease Who Have Failed or Are Intolerant of Standard Therapy


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

2 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:October 2007
Last Changed Date:October 1, 2007
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Sorivudine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 29, 2021

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