Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00940771|
Recruitment Status : Unknown
Verified October 2015 by Janice Piatt, Phoenix Children's Hospital.
Recruitment status was: Active, not recruiting
First Posted : July 16, 2009
Last Update Posted : October 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pediatric HIV HIV Infections||Drug: Boosted Atazanavir||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
|Experimental: boosted atazanavir||
Drug: Boosted Atazanavir
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
Other Name: Reyataz
- Viral Load [ Time Frame: 6 months ]
- CD4 Count [ Time Frame: 6 months ]
- Non-fasting cholesterol [ Time Frame: 6 months ]
- Non-fasting triglycerides [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940771
|United States, Arizona|
|Phoenix Children's Hospital|
|Phoenix, Arizona, United States, 85016|
|Principal Investigator:||Janice Piatt, MD||Phoenix Children's Hospital|