HIV-infected ChildrenPhase 3NCT01307124
Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)
A Phase 3 study testing kaletra in people with HIV-infected Children, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in Thailand.
Trial summary
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- HIV-infected Children
- What is being tested?
- kaletra
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 10 sitesThailand
- Study dates
- Mar 2011to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infection children age < 18 years old
- Currently on PI regimens
- HIV RNA viral load < 50 copies/ml at screening
- BW 25-50 kg
- Written informed consent
Who cannot join
- Relevant history or current condition of PI resistance, plasma HIV RNA > 1000 copies/ml after received the PI regimens for at least 6 months
- On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir
- On double boosted protease inhibitors
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Thailand10 sites
Queen Sirikit National Institute of Child Health
Bangkok
Prapokklao Hospital
Chanthaburi
Nakornping Hospital
Chiang Mai
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Changwat Khon Kaen
Bamrasnaradura Institute
Nonthaburi, Changwat Nonthaburi, 11000
Phrachomklao Hospital
Phetchaburi
Buddhachinaraj Hospital
Phitsanulok
Surin Hospital
Surin
Sappasitthiprasong Hospital
Ubonratchathani
Udonthani Hospital
Udon Thani
About this study
Official title: A Multicenter Randomized Study to Compare the Safety and Efficacy of Low-dose Versus Standard Dose Lopinavir/Ritonavir Containing HAART Regimen in Virological Suppressed HIV-infected Thai Children
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week
- Conditions
- HIV-infected Children
- Being tested
- kaletra
- Keywords
- safety and efficacy, low dose LPV/r, standard dose LPV/r, HIV infected children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kaletraDrug
The study participants will receive Lopinavir/ritonavir heat-stable tablet (100/25 mg or 200/50 mg) q 12 hour plus NRTIs. The other NRTIs is depend on physician discretion.
Arm 1:LPV/r Standard dose Arm 2:Low dose BW 25-35 kg 300/75 mg 200/50 mg BW >35-50 kg 400/100 mg 300/75 mg
| Study group | Role | What they receive |
|---|---|---|
| standard dose | Active comparator | Arm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW >35-50 kg 400/100 mg Receives: Drug: kaletra |
| low dose | Experimental | Arm 2:Low dose BW 25-35 kg 200/50 mg BW >35-50 kg 300/75 mg Receives: Drug: kaletra |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week
proportion of patient who had HIV RNA < 50 copies/ml Safety issue: patient who had HIV RNA > 50 copies/ml during the study period will be checked for LPV blood level, if the LPV Cmin < 1 ug/ml. The dose of LPV/r will be adjusted to appropriate dose.
Measured: 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-infected ChildrenStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Queen Sirikit National Institute of Child Health, Srinagarind Hospital, Khon Kaen University, Bamrasnaradura Infectious Diseases Institute, Nakornping Hospital, Prapokklao Hospital, Surin Hospital, Sappasitthiprasong Hospital, UdonThani Hospital, Buddhachinaraj Hospital, Phrachomklao Hospital
- Responsible party
- Sponsor
- Investigators
- Thanyawee Puthanakit, MD, Principal investigator, Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307124
- Sponsor's protocol ID
- HIV-NAT 152
- Status last verified
- Mar 2015
- First submitted
- 3 Feb 2011
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
A randomized study comparing low dose versus standard dose lopinavir/ritonavir among HIV-infected children with virological suppression . Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation.
Association of SCLO1B1 polymorphism and plasma concentration of lopinavir in HIV-infected children. Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation and 5th International Workshop on HIV Pediatrics in June 28-29, 2013 in Kuala Lumpur, Malaysia
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Study to Compare the Safety and Efficacy of Low-dose Versus Standard Dose Lopinavir/Ritonavir Containing HAART Regimen in Virological Suppressed HIV-infected Thai Children
- ClinicalTrials.gov ID
- NCT01307124
- Acronym / sponsor ID
- HIV-NAT 152
- Conditions
- HIV-infected Children
- Keywords
- safety and efficacy, low dose LPV/r, standard dose LPV/r, HIV infected children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Queen Sirikit National Institute of Child Health, Srinagarind Hospital, Khon Kaen University, Bamrasnaradura Infectious Diseases Institute, Nakornping Hospital, Prapokklao Hospital, Surin Hospital, Sappasitthiprasong Hospital, UdonThani Hospital, Buddhachinaraj Hospital, Phrachomklao Hospital
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard dose | Active comparator | Drug: kaletraArm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW >35-50 kg 400/100 mg |
| low dose | Experimental | Drug: kaletraArm 2:Low dose BW 25-35 kg 200/50 mg BW >35-50 kg 300/75 mg |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- HIV infection children age < 18 years old
- Currently on PI regimens
- HIV RNA viral load < 50 copies/ml at screening
- BW 25-50 kg
- Written informed consent
Key exclusion criteria (3 listed)
- Relevant history or current condition of PI resistance, plasma HIV RNA > 1000 copies/ml after received the PI regimens for at least 6 months
- On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir
- On double boosted protease inhibitors
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 |
|---|---|---|
| kaletraThe study participants will receive Lopinavir/ritonavir heat-stable tablet (100/25 mg or 200/50 mg) q 12 hour plus NRTIs. The other NRTIs is depend on physician discretion. Arm 1:LPV/r Standard dose Arm 2:Low dose BW 25-35 kg 300/75 mg 200/50 mg BW >35-50 kg 400/100 mg 300/75 mg | Drug | low dose, standard dose |
Primary outcome
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week
Time frame: 48 week
proportion of patient who had HIV RNA < 50 copies/ml Safety issue: patient who had HIV RNA > 50 copies/ml during the study period will be checked for LPV blood level, if the LPV Cmin < 1 ug/ml. The dose of LPV/r will be adjusted to appropriate dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Results publicationA randomized study comparing low dose versus standard dose lopinavir/ritonavir among HIV-infected children with virological suppression . Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation.
- Results publicationAssociation of SCLO1B1 polymorphism and plasma concentration of lopinavir in HIV-infected children. Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation and 5th International Workshop on HIV Pediatrics in June 28-29, 2013 in Kuala Lumpur, Malaysia
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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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.
Thanyawee Puthanakit, MD principal investigator
Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing kaletra in people with HIV-infected Children, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in Thailand.
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 5 inclusion and 3 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week (time frame: 48 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307124, which also lists 2 linked publications.
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 25 Mar 2015.