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Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens

Primary Purpose

Pediatric HIV, HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Boosted Atazanavir
Sponsored by
Phoenix Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric HIV focused on measuring HIV, Lipids, Atazanavir, Pediatric, treatment experienced

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

boosted Atazanavir

Arm Description

Boosted Atazanavir was switched for the PI or NNRTI in the patients regimen

Outcomes

Primary Outcome Measures

Non-fasting Cholesterol
Non-fasting Triglycerides

Secondary Outcome Measures

Viral Load
Number of participants with undetectable viral load
CD4 Count

Full Information

First Posted
July 15, 2009
Last Updated
April 15, 2020
Sponsor
Phoenix Children's Hospital
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00940771
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 26, 2009 (Actual)
Primary Completion Date
October 16, 2013 (Actual)
Study Completion Date
November 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix Children's Hospital
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric HIV, HIV Infections
Keywords
HIV, Lipids, Atazanavir, Pediatric, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
boosted Atazanavir
Arm Type
Experimental
Arm Description
Boosted Atazanavir was switched for the PI or NNRTI in the patients regimen
Intervention Type
Drug
Intervention Name(s)
Boosted Atazanavir
Other Intervention Name(s)
Reyataz
Intervention Description
Boosted Atazanavir, once a day dose adjusted for child's weight for 6 months.
Primary Outcome Measure Information:
Title
Non-fasting Cholesterol
Time Frame
4 Weeks, 12 weeks, 24 weeks
Title
Non-fasting Triglycerides
Time Frame
4 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Viral Load
Description
Number of participants with undetectable viral load
Time Frame
4 weeks, 12 weeks, 24 weeks
Title
CD4 Count
Time Frame
4 Weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Piatt, MD
Organizational Affiliation
Phoenix Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens

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