Clinical trial NCT00940771: Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatric HIV
HIV Infections
Keywords: HIV
Lipids
Atazanavir
Pediatric
treatment experienced
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-07-16
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.

Primary outcomes:
measure: Non-fasting Cholesterol
timeFrame: 4 Weeks, 12 weeks, 24 weeks
measure: Non-fasting Triglycerides
timeFrame: 4 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Viral Load
timeFrame: 4 weeks, 12 weeks, 24 weeks
measure: CD4 Count
timeFrame: 4 Weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Janice Piatt, MD
role: PRINCIPAL_INVESTIGATOR
References: