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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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002358
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2007-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chickenpox, HIV Infections

Keywords

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

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.

Detailed description

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

Interventions

DRUGSorivudine

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026