Trial record 6 of 36 for:    " July 01, 2009":" July 31, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Janice Piatt, Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT00940771
First received: July 15, 2009
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

The hypothesis for this study is will a treatment regimen containing Atazanavir in combination with Ritonavir work as well as other regimens containing a protease inhibitor (PI, one of 5 classes of HIV Medications) and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI, another of the classes of HIV medications) 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.


Condition Intervention Phase
Pediatric HIV
HIV Infections
Drug: Boosted Atazanavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:
  • Viral Load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • CD4 Count [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-fasting cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Non-fasting triglycerides [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: boosted atazanavir Drug: Boosted Atazanavir
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
Other Name: Reyataz

Detailed Description:

The objectives of this study are to see 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 will that combination be as effective as the previous regimen in keeping the infection fighting cells in the blood at the same level.

  • To see if cholesterol and triglyceride levels drop in children switching to Atazanavir and Ritonavir from other medication regimens.
  • To see 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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940771

Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Sponsors and Collaborators
Phoenix Children's Hospital
Bristol-Myers Squibb
Investigators
Principal Investigator: Janice Piatt, MD Phoenix Children's Hospital
  More Information

No publications provided

Responsible Party: Janice Piatt, Medical Director, Bill Holt Clinic, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT00940771     History of Changes
Other Study ID Numbers: PCH 09-004
Study First Received: July 15, 2009
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Phoenix Children's Hospital:
HIV
Lipids
Atazanavir
Pediatric
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014