Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
Condition: Pediatric HIV; HIV Infections
MeSH terms: HIV Infections
Intervention: Boosted Atazanavir
Intervention description: Boosted Atazanavir, once a day dose adjusted for child's weight for 6 months.
Intervention MeSH terms: Atazanavir Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Lipids; Atazanavir; Pediatric; treatment experienced

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV positive children with elevated lipid levels

          -  on stable HAART for at least 3 months (defined to be on the same regimen with viral
             load < 1000 for 6 months prior to baseline visit).

          -  Weight equal to or greater than 25kg

          -  Able to swallow pills or willing to learn

        Exclusion Criteria:

          -  Patients with underlying hepatitis B or C viral infections

          -  Previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson
             syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of
             Reyataz® (atazanavir).

          -  Taking other medications that are highly dependent on CYP3A or UGT1A1 for clearance

               -  Ergot medicines: dihydroergotamine, ergonovine, ergotamine, and methylergonovine
                  such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and
                  others (used for migraine headaches).

               -  Orap® (pimozide, used for Tourette's disorder).

               -  Propulsid® (cisapride, used for certain stomach problems).

               -  Triazolam, also known as Halcion® (used for insomnia).

               -  Midazolam, also known as Versed® (used for sedation), when taken by mouth.

               -  Camptosar® (irinotecan, used for cancer).

               -  Crixivan® (indinavir, used for HIV infection).

               -  Cholesterol-lowering medicines Mevacor® (lovastatin) or Zocor® (simvastatin).

               -  Rifampin (also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®).

               -  St. John's wort (Hypericum perforatum), an herbal product sold as a dietary
                  supplement,

               -  Viramune® (nevirapine, used for HIV infection).

               -  Vfend® (voriconazole).

          -  Patients with grade 3 or higher elevations in transaminases (> 10 X ULN)

          -  Women of Childbearing Potential who are unwilling or unable to use an acceptable
             method to avoid pregnancy for the entire study period.

          -  Women who are pregnant or breastfeeding.

          -  Women with a positive pregnancy test.