Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens

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

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.