Evaluation of pharmacokinetics, safety, tolerance, and activity of combination of zalcitabine and zidovudine in stable, zidovudine-treated pediatric patients with human immunodeficiency virus infection
| Autor: | Paula Britto, David A. Schoenfeld, Suraiya Rasheed, Edmund V. Capparelli, Lynne M. Mofenson, Mary Glen Fowler, Saroj S. Bakshi, Savita Pahwa, Gloria S. Boone, Ram Yogev, Bonnie Zimmer, Yitzchak Frank, Eleanor Jimenez, Miklos Salgo |
|---|---|
| Předmět: |
Chemotherapy
medicine.medical_specialty Combination therapy biology business.industry medicine.medical_treatment Phases of clinical research Neutropenia biology.organism_classification medicine.disease Gastroenterology Surgery Zalcitabine Zidovudine Infectious Diseases Internal medicine medicine Immunology and Allergy business Sida Survival rate medicine.drug |
| Zdroj: | Scopus-Elsevier |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|