Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens - Full Text View

Sponsors and Collaborators:	Phoenix Children's Hospital Bristol-Myers Squibb
Information provided by:	Phoenix Children's Hospital
ClinicalTrials.gov Identifier:	NCT00940771

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
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:

MedlinePlus related topics: AIDS Cholesterol

Drug Information available for: BMS 232632 Atazanavir sulfate

U.S. FDA Resources

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:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
boosted atazanavir: Experimental	Drug: Boosted Atazanavir Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.

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).
- Crixavan® (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

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

Locations

United States, Arizona
Phoenix Children's Hospital	Recruiting
Phoenix, Arizona, United States, 85016
Contact: Laura Clarke-Steffen, PhD, RN 602-546-0234 lclarke@phoenixchildrens.com
Principal Investigator: Janice Piatt, MD

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:	Phoenix Children's Hospital ( Janice Piatt, MD, Principal Investigator )
Study ID Numbers:	PCH 09-004
Study First Received:	July 15, 2009
Last Updated:	August 14, 2009
ClinicalTrials.gov Identifier:	NCT00940771 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Phoenix Children's Hospital:

HIV
Lipids
Atazanavir
Pediatric
treatment experienced

Study placed in the following topic categories:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents

Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Atazanavir
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 11, 2009