Treatment of human immunodeficiency virus 1-infected infants and children with the protease inhibitor nelfinavir mesylate.

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Treatment of human immunodeficiency virus 1-infected infants and children with the protease inhibitor nelfinavir mesylate.

Clin Infect Dis. 1999 May;28(5):1109-18. Unique Identifier : AIDSLINE MED/99379713
Krogstad P; Wiznia A; Luzuriaga K; Dankner W; Nielsen K; Gersten M; Kerr B; Hendricks A; Boczany B; Rosenberg M; Jung D; Spector SA; Bryson Y; Department of Pediatrics, UCLA, Los Angeles, California,; 90095-3075, USA. pkrogsta@pediatrics.medsch.ucla.edu

Abstract: An open-label study was conducted of nelfinavir mesylate, given with reverse transcriptase inhibitors to human immunodeficiency virus 1 (HIV-1)-infected infants and children 3 months to 13 years of age. Doses of nelfinavir mesylate of 20-30 mg/kg yielded drug exposures comparable to those seen in adults. The drug was well tolerated; mild diarrhea was the primary toxic effect observed. Seventy-one percent (39) of the 55 evaluable subjects had an initial decrease in plasma HIV-1 RNA, of at least 0.7 log10 copies/mL; suppression of plasma HIV-1 RNA levels to < 400 copies/mL was observed in 15. Children who began taking at least one new reverse transcriptase inhibitor near the time when nelfinavir mesylate was started, and those with a > or = 24% proportion of CD4 lymphocytes, had a greater chance of achieving and maintaining a decline in plasma HIV-1 RNA to < 400 copies/mL. Suppression of viremia was achieved in children as young as 3 months of age.

Keywords: CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY Adolescence Anti-HIV Agents/THERAPEUTIC USE Child Child, Preschool CD4 Lymphocyte Count/DRUG EFFECTS Drug Therapy, Combination Female Human HIV Infections/*DRUG THERAPY HIV Protease Inhibitors/ADVERSE EFFECTS/PHARMACOKINETICS/ *THERAPEUTIC USE *HIV-1/DRUG EFFECTS/ISOLATION & PURIF Infant Male Nelfinavir/ADVERSE EFFECTS/PHARMACOKINETICS/*THERAPEUTIC USE Reverse Transcriptase Inhibitors/THERAPEUTIC USE RNA, Viral/BLOOD Support, Non-U.S. Gov't
991230
A99C1039

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