CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
ATV +1 moredrug
Likely dose
Atazanavir 50 mg, 100 mg, or 200 mg capsules or powder formulation depending on age/weight; ritonavir 100 mg capsules or oral solutionAI-extracted
Key inclusion· 6
  • ✓Age 91 days to 21 years (not including 22nd birthday)
  • ✓Confirmed HIV infection diagnosis per IMPAACT Virology Core Laboratory Committee definition
  • ✓Viral load ≥5000 copies/mL
  • ✓Ability to add two new NRTIs or documented genotypic sensitivity to two NRTIs in recommended combinations
Key exclusion· 12
  • ✕Active hepatitis
  • ✕Acute serious/invasive infection requiring therapy at enrollment
  • ✕Hypersensitivity to any component of ATV formulation
  • ✕Chemotherapy for active malignancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006604
NCT00006604Phase 2Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 5, 2021

In Brief

A Phase 2 clinical trial evaluating ATV and Ritonavir for HIV Infections. Completed, enrolled 195 participants across 36 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, South Africa, United States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Enrollment StartNov 1, 2000
Primary CompletionOct 1, 2011
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10.9 yearsPosted 24.8 years ago

Interventions

ATVdrug

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.

Ritonavirdrug

Administered as 100 mg capsules or oral solution.