Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
The hypothesis for this study is will a treatment regimen containing Atazanavir in combination with Ritonavir work as well as other regimens containing a protease inhibitor (PI, one of 5 classes of HIV Medications) and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI, another of the classes of HIV medications) at controlling HIV disease in children who are HIV+ and have high cholesterol or high triglycerides. . In this study, children who have high cholesterol or high triglycerides as a result of their HIV medicines, will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of atazanavir and ritonavir will be according to the Package Insert for this drug that is FDA approved for children. They will continue taking the other medications from the pre-study regimen. Children will take study drug for 24 weeks, and will be able to continue study drug after the study using commercially available drug. Lab tests and a physical exam will be undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how effective the new drug is and to monitor for possible side effects.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens With Other PI's/NNRTI's in HIV+ Children and Adolescents With Elevated Lipid Levels|
- Viral Load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- CD4 Count [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Non-fasting cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Non-fasting triglycerides [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: boosted atazanavir||
Drug: Boosted Atazanavir
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
Other Name: Reyataz
The objectives of this study are to see if Atazanavir and Ritonavir together will be as effective as the child's previous regimen in keeping the level of virus in the blood stream at such a low level it can't be found and will that combination be as effective as the previous regimen in keeping the infection fighting cells in the blood at the same level.
- To see if cholesterol and triglyceride levels drop in children switching to Atazanavir and Ritonavir from other medication regimens.
- To see if Atazanavir and Ritonavir result in an increase in patient satisfaction and patient reported adherence and a decrease in symptoms related to medication side effects.
Inclusion Criteria are:
- On the same medication regimen at least 3 months
- Weight equal to or greater than 25kg
- Able to swallow pills or willing to learn
- Have a parent or guardian willing and able to sign informed consent
- Not be taking a medication which interacts with Atazanavir
- Not be currently taking sustiva
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940771
|United States, Arizona|
|Phoenix Children's Hospital|
|Phoenix, Arizona, United States, 85016|
|Principal Investigator:||Janice Piatt, MD||Phoenix Children's Hospital|