Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens

HIV Infections Clinical Trial

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

Status Completed

Clinical Trial Summary

The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) 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.

Clinical Trial Description

The primary objective of this study is to determine 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 whether that combination will be as effective as the previous regimen in keeping the infection fighting cells in the blood at the same level.

Secondary objectives will be:

• To determine if cholesterol and triglyceride levels drop in children switching to Atazanavir and Ritonavir from other medication regimens.

• To evaluate 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 ;

Related Conditions & MeSH terms

• HIV Infections
• Pediatric HIV

• NCT number: NCT00940771
• Study type: Interventional
• Source: Phoenix Children's Hospital
• Status: Completed
• Phase: Phase 4
• Start date: August 26, 2009
• Completion date: November 23, 2016