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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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:
Inclusion Criteria are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| boosted Atazanavir | Experimental | Boosted Atazanavir was switched for the PI or NNRTI in the patients regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boosted Atazanavir | Drug | Boosted Atazanavir, once a day dose adjusted for child's weight for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-fasting Cholesterol | 4 Weeks, 12 weeks, 24 weeks | |
| Non-fasting Triglycerides | 4 weeks, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load | Number of participants with undetectable viral load | 4 weeks, 12 weeks, 24 weeks |
| CD4 Count | 4 Weeks, 12 weeks, 24 weeks |
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Inclusion Criteria:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Janice Piatt, MD | Phoenix Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
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Pediatric patients with elevated cholesterol were recruited from a Pediatric HIV Clinic between April 8, 2009 and May 1, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Boosted Atazanavir | Boosted atazanavir was switched for the PI or NNRTI in the patients regimen Boosted atazanavir, once a day dose adjusted for child's weight for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Entry |
| |||||||||||||
| 4 Weeks |
| |||||||||||||
| 12 Weeks |
| |||||||||||||
| 24 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Boosted Atazanavir | Boosted atazanavir was switched for the PI or NNRTI in the patients regimen Boosted Atazanavir: Boosted atazanavir, once a day dose adjusted for child's weight for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Non-fasting Cholesterol | Posted | Mean | Standard Deviation | mg/dL | 4 Weeks, 12 weeks, 24 weeks |
|
|
24 weeks
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events V 1.0, December 2004, Clarification August 2009 was used to grade labs and symptoms that were reported at week 4, week 12 and week 24 visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Boosted Atazanavir | Boosted atazanavir was switched for the PI or NNRTI in the patients regimen Boosted atazanavir, once a day dose adjusted for child's weight for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pansinusitis | Infections and infestations | Division of AIDS 1.0 | Systematic Assessment | Pansinusitis requiring hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain, neck and face | Blood and lymphatic system disorders | Division of AIDS 1.0 | Systematic Assessment | Pain grade 2 associated with parotitis |
Small sample size Non fasting lipid levels Large variety of prior treatment regimens
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janice Piatt, MD, Medical Director | Bill Holt Clinic, Phoenix Children's Hospital | 602-933-0955 | jpiatt@phoenixchildrens.com |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CD4 | Mean | Standard Deviation | cells/uL |
|
| Viral Load | Mean | Standard Deviation | copies/ml |
|
| Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
|
|
| Primary | Non-fasting Triglycerides | Posted | Mean | Standard Deviation | mg/dL | 4 weeks, 12 weeks, 24 weeks |
|
|
|
|
| Secondary | Viral Load | Number of participants with undetectable viral load | Number of patients with undetectable viral load | Posted | Count of Participants | Participants | 4 weeks, 12 weeks, 24 weeks |
|
|
|
|
| Secondary | CD4 Count | Posted | Mean | Standard Deviation | cells/uL | 4 Weeks, 12 weeks, 24 weeks |
|
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 2 |
| 10 |
|
|
| Fever | General disorders | Division of AIDS 1.0 | Systematic Assessment | Fever grade 2 associated with Parotitis or Upper Respiratory Infection |
|
| Pain, throat | Respiratory, thoracic and mediastinal disorders | Division of AIDS 1.0 | Systematic Assessment | pain grade 2 associated with Upper Respiratory Infection |
|
| cough | Respiratory, thoracic and mediastinal disorders | Division of AIDS 1.0 | Systematic Assessment | Cough grade 2 associated with Upper Respiratory Infection |
|
| Vomiting | Gastrointestinal disorders | Division of AIDS 1.0 | Systematic Assessment | Grade 3 vomiting associated with parotitis |
|
| Laboratory Abnormality | Gastrointestinal disorders | Division of AIDS 1.0 | Systematic Assessment | Elevated Bilirubin, grade 3 |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
|