Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)
NCT ID: NCT01307124
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
199 participants
INTERVENTIONAL
2011-03-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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standard dose
Arm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW \>35-50 kg 400/100 mg
kaletra
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
low dose
Arm 2:Low dose BW 25-35 kg 200/50 mg BW \>35-50 kg 300/75 mg
kaletra
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
Interventions
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kaletra
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
Eligibility Criteria
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Inclusion Criteria
2. Currently on PI regimens
3. HIV RNA viral load \< 50 copies/ml at screening
4. BW 25-50 kg
5. Written informed consent
Exclusion Criteria
2. On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir
3. On double boosted protease inhibitors
18 Years
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Queen Sirikit National Institute of Child Health
OTHER_GOV
Srinagarind Hospital, Khon Kaen University
OTHER
Bamrasnaradura Infectious Diseases Institute
OTHER_GOV
Nakornping Hospital
OTHER
Prapokklao Hospital
UNKNOWN
Surin Hospital
UNKNOWN
Sappasitthiprasong Hospital
UNKNOWN
UdonThani Hospital
OTHER_GOV
Buddhachinaraj Hospital
OTHER
Phrachomklao Hospital
UNKNOWN
The HIV Netherlands Australia Thailand Research Collaboration
OTHER
Responsible Party
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Principal Investigators
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Thanyawee Puthanakit, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT
Locations
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Srinagarind Hospital, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand
Bamrasnaradura Institute
Nonthaburi, Changwat Nonthaburi, Thailand
Queen Sirikit National Institute of Child Health
Bangkok, , Thailand
Prapokklao Hospital
Chanthaburi, , Thailand
Nakornping Hospital
Chiang Mai, , Thailand
Phrachomklao Hospital
Phetchaburi, , Thailand
Buddhachinaraj Hospital
Phitsanulok, , Thailand
Surin Hospital
Surin, , Thailand
Sappasitthiprasong Hospital
Ubonratchathani, , Thailand
Udonthani Hospital
Udon Thani, , Thailand
Countries
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References
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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
Related Links
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HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Other Identifiers
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HIV-NAT 152
Identifier Type: -
Identifier Source: org_study_id
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