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.

Condition	Treatment or Intervention	Phase
HIV Infections Chickenpox	Drug: Sorivudine	Phase III

Further Study Details: 

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

Ages Eligible for Study:  2 Years   -   17 Years,  Genders Eligible for Study:  Both

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.

Connecticut
      Bristol - Myers Squibb Co, Wallingford,  Connecticut,  06492,  United States

Study ID Numbers:  255A; AI458-903
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002358
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08