Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
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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 |
- Viral Load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- CD4 Count [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| United States, Arizona | |
| Phoenix Children's Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Contact: Laura Clarke-Steffen, PhD, RN 602-933-0234 lclarke@phoenixchildrens.com | |
| Principal Investigator: Janice Piatt, MD | |
| 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 29, 2012 |
| 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 March 14, 2013
