PEDIATRICS Vol. 88 No. 2 August 1991, pp. 364-370
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Low-Dose Zidovudine in Children With an Human Immunodeficiency Virus Type 1 Infection Acquired in the Perinatal Period

Stephane Blanche MD1, Anne-Marie Duliege MD1, Marianne Debré MD1, Claude Griscelli MD1, Maria Soledad Navarette MD2, Serge Kouzan MD2, Marc Tardieu MD3, Christine Rouzioux MD4, and Jorgen Seldrup PhD5

1 From the Pediatric Immunology Division, Necker Hospital, Institut National de la Santé et de la Recherche Médicale U132
2 Laboratories Wellcome, Paris
3 Pediatric Neurology Division, Bicêtre Hospital, Institut National de la Santé et de la Recherche Médicale U56
4 The Virology Division, Necker Hospital
5 Institut Technique pour I'Etude du Médicament, Le Kremlin-Bicêtre, France

This report describes the one-year results of a noncomparative study designed to assess the safety and tolerance of low-dose zidovudine (azidothymidine) given orally to 60 human immunodeficiency virus type 1-infected infants and children. At baseline, the mean age was 1.9 years (±1.4), and all were symptomatic: 43% were P2A and 57% were P2B to F according to the Centers for Disease Control classification. All the patients received zidovudine for at least 6 months, and 52 of them (87%) completed a full year of therapy. The mean duration of follow-up was 346 days (±42) (range, 183 to 366 days).

The initial therapy consisted of four daily doses of 100 mg/m2 (400 mg/m2 per day, equivalent to 20 mg/kg per day). However, this treatment was modified when neutropenia or anemia was observed. Twenty-nine children (48%) remained at the initial therapy for the entire study. Zidovudine dosage was adjusted 92 times in the other 31 children (52%), mostly due to neutropenia (83%). Altogether, the time under full-dose therapy represented 81% of the total duration of the protocol for all patients. Children with mild symptoms, P2A at study entry, were more likely to remain under full-dose therapy than children with severe symptoms, P2B to F: the time under full-dose therapy represented 91% of the duration of the protocol for the former group and only 74% for the latter one (P < .02). No clinical adverse experiences were attributed directly to zidovudine. Thirty-seven children were prescribed trimethoprim-sulfametoxazole as a prophylaxis for Pneumocystis carinii pneumonia. In a multivariate analysis, this comedication had no influence on the hematologic tolerance of zidovudine.

Submitted on August 24, 1990
Accepted on December 17, 1990