Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
Condition: Pediatric HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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
    

Intervention name(s): Boosted Atazanavir
Intervention type(s): Drug
Intervention description(s): Boosted Atazanavir, once a day dose adjusted for child's weight for 6 months.
Other intervention name(s): Reyataz
Intervention MeSH terms: Atazanavir Sulfate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Lipids; Atazanavir; Pediatric; treatment experienced