Status:
COMPLETED
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
Lead Sponsor:
Phoenix Children's Hospital
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Pediatric HIV
HIV Infections
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
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-nucleo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 26 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00940771
Start Date
August 26 2009
End Date
November 23 2016
Last Update
April 20 2020
Active Locations (1)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016