Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Treatments:
Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Ritonavir