Clinical trial NCT00006604: Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
Official title: Phase I/II, Open-Label, Pharmacokinetic and Safety Study of a Novel Protease Inhibitor (BMS 232632, Atazanavir, ATV, Reyataz) in Combination Regimens in Antiretroviral Therapy (ART)-Naive and -Experienced HIV-Infected Infants, Children, and Adolescents
Conditions: HIV Infections
Summary: The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents.
Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
Interventions:
description: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
name: ATV
type: Drug
description: Administered as 100 mg capsules or oral solution.
name: Ritonavir
type: Drug
Study arms:
design_group_description: Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2, 620 mg/m^2; Final Dose: Not Established
design_group_title: Step I: Group 1
design_group_type: Experimental
design_group_description: Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2, 620 mg/m^2; Final Dose: Not Established
design_group_title: Step I: Group 2
design_group_type: Experimental
design_group_description: Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2, 415 mg/m2, 520 mg/m^2; Final Dose: 520 mg/m^2
design_group_title: Step I: Group 3
design_group_type: Experimental
design_group_description: Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2, 520 mg/m^2, 620 mg/m^2; Final Dose: 620 mg/m^2
design_group_title: Step I: Group 4
design_group_type: Experimental
design_group_description: Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2
design_group_title: Step I: Group 5
design_group_type: Experimental
design_group_description: Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2
design_group_title: Step I: Group 5a
design_group_type: Experimental
design_group_description: Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2
design_group_title: Step I: Group 6
design_group_type: Experimental
design_group_description: Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2, 205 mg/m^2; Final Dose: 205 mg/m^2
design_group_title: Step I: Group 7
design_group_type: Experimental
design_group_description: Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.<br/>ATV Dose Tested: 310 mg/m^2, 205 mg/m^2; Final Dose: 205 mg/m^2
design_group_title: Step I: Group 8
design_group_type: Experimental
Sponsor: National Institute of Allergy & Infectious Diseases
Collaborators: National Institute of Child Health & Human Development
Drug name mappings:
name: 硫酸阿扎那韦
lang: CN
name: Atazanavir Sulfate
lang: EN
name: アタザナビル硫酸塩
lang: JP
name: 利托那韦
lang: CN
name: Ritonavir
lang: EN
name: リトナビル
lang: JP