Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 6 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | April 2009 |
| End Date: | December 2016 |
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
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.
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.
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
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
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.
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