Pediatric HIVPhase 4NCT00940771
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
A Phase 4 study testing Boosted Atazanavir in people with Pediatric HIV and HIV Infections, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric HIV, HIV Infections
- What is being tested?
- Boosted Atazanavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2009to 23 Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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:
- To determine if cholesterol and triglyceride levels drop in children switching to Atazanavir and Ritonavir from other medication regimens.
- To evaluate 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
- Conditions
- Pediatric HIV, HIV Infections
- Being tested
- Boosted Atazanavir
- Keywords
- HIV, Lipids, Atazanavir, Pediatric, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boosted AtazanavirDrug
Also called Reyataz
Boosted Atazanavir, once a day dose adjusted for child's weight for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| boosted Atazanavir | Experimental | Boosted Atazanavir was switched for the PI or NNRTI in the patients regimen Receives: Drug: Boosted Atazanavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-fasting Cholesterol
Measured: 4 Weeks, 12 weeks, 24 weeks
Non-fasting Triglycerides
Measured: 4 weeks, 12 weeks, 24 weeks
Secondary outcomes (2)
Viral Load
Number of participants with undetectable viral load
Measured: 4 weeks, 12 weeks, 24 weeks
CD4 Count
Measured: 4 Weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study start26 Aug 2009
- Primary completion16 Oct 2013
- Study completion23 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Janice Piatt, Phoenix Children's Hospital
- Investigators
- Janice Piatt, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940771
- Sponsor's protocol ID
- PCH 09-004
- Status last verified
- Apr 2020
- First submitted
- 15 Jul 2009
- Last updated
- 20 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00940771
- Acronym / sponsor ID
- PCH 09-004
- Conditions
- Pediatric HIV, HIV Infections
- Keywords
- HIV, Lipids, Atazanavir, Pediatric, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 26 Aug 2009 (actual)
- Primary completion
- 16 Oct 2013 (actual)
- Study completion
- 23 Nov 2016 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Posted 20 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To determine if cholesterol and triglyceride levels drop in children switching to Atazanavir and Ritonavir from other medication regimens.
- To evaluate 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| boosted Atazanavir | Experimental | Drug: Boosted AtazanavirBoosted Atazanavir was switched for the PI or NNRTI in the patients regimen |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boosted AtazanavirAlso: ReyatazBoosted Atazanavir, once a day dose adjusted for child's weight for 6 months. | Drug | boosted Atazanavir |
Primary outcome
Non-fasting Cholesterol
Time frame: 4 Weeks, 12 weeks, 24 weeks
Non-fasting Triglycerides
Time frame: 4 weeks, 12 weeks, 24 weeks
2 secondary outcomes
Viral Load
Time frame: 4 weeks, 12 weeks, 24 weeks
CD4 Count
Time frame: 4 Weeks, 12 weeks, 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Piatt, MD principal investigator
Phoenix Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boosted Atazanavir in people with Pediatric HIV and HIV Infections, run by Phoenix Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-fasting Cholesterol (time frame: 4 Weeks, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.