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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: HIV Infections; Chickenpox

Treatments: Drug: Sorivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002358

AI458-903

255A

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.