Evaluation of Pharmacokinetics, Safety, Tolerance, and Activity of Combination of Zalcitabine and Zidovudine in Stable, Zidovudine-Treated Pediatric Patients with Human Immunodeficiency Virus Infection

A double-blind phase II trial compared zalcitabine (0.03 mg/kg/day) in combination with zidovudine (720 mg/m2/day) and zidovudine monotherapy in 250 clinically stable, previously zidovudine-treated, human immunodeficiency virus—infected children. The combination was well-tolerated except for an incr...

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Bibliographic Details
Published in:The Journal of infectious diseases 1997-05, Vol.175 (5), p.1039-1050
Main Authors: Bakshi, Saroj S., Britto, Paula, Capparelli, Edmund, Mofenson, Lynne, Fowler, Mary Glen, Rasheed, Suraiya, Schoenfeld, David, Zimmer, Bonnie, Frank, Yitzchak, Yogev, Ram, Jimenez, Eleanor, Salgo, Miklos, Boone, Gloria, Pahwa, Savita G.
Format: Article
Language:English
Subjects:
AIDS
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiretrovirals
Antiviral agents
Antivirals
Biological and medical sciences
Child health services
Dosage
HIV
Infections
Major Articles
Medical sciences
Pharmacokinetics
Pharmacology. Drug treatments
Virology
Viruses
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Summary:A double-blind phase II trial compared zalcitabine (0.03 mg/kg/day) in combination with zidovudine (720 mg/m2/day) and zidovudine monotherapy in 250 clinically stable, previously zidovudine-treated, human immunodeficiency virus—infected children. The combination was well-tolerated except for an increased incidence of neutropenia (14%) compared with that in children receiving monotherapy (5%). No differences were noted for time to first AIDS-defining illness or death, neuropsychologic status, or weight Z scores. In patients in the combination arm, the CD4 cell count decline was slower (13% per year) than in patients receiving monotherapy (25% per year) (P = .03), and quantitative peripheral blood mononuclear cell virus load remained lower at all time points (P = .08). Deaths were fewer in patients receiving combination therapy (4) compared with those in patients receiving monotherapy (10) (P = .083). Thus, administration of zidovudine with zalcitabine to children with prior zidovudine treatment did not result in a significant increase in toxicity compared with that resulting from zidovudine monotherapy and demonstrated improvement in immunologic and virologic surrogate markers.
ISSN:0022-1899
1537-6613
DOI:10.1086/520351