Low-dose zidovudine in children with an human immunodeficiency virus type 1 infection acquired in the perinatal period.
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 less than .02). No clinical adverse experiences were attributed directly to zidovudine. Thirty-seven children were prescribed trimethoprim-sulfametoxazole as a prophylaxis for Pneumocystis carinii pneumonia.(ABSTRACT TRUNCATED AT 250 WORDS)
Blanche
S
S
Pediatric Immunology Division, Necker Hospital, Institut National de la Santé et de la Recherche Médicale U132, Paris, France.
Duliege
A M
AM
Navarette
M S
MS
Tardieu
M
M
Debré
M
M
Rouzioux
C
C
Seldrup
J
J
Kouzan
S
S
Griscelli
C
C
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007116:Immunization, Passive; D007223:Infant; D007654:Ketoconazole / Q000627:therapeutic use; D008297:Male; D009894:Opportunistic Infections / Q000517:prevention & control; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use; D015215:Zidovudine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D015215:Zidovudine; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D007654:Ketoconazole