Clinical trial NCT01307124: Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-infected Children
Keywords: safety and efficacy
low dose LPV/r
standard dose LPV/r
HIV infected children
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
name: Queen Sirikit National Institute of Child Health
name: Srinagarind Hospital, Khon Kaen University
name: Bamrasnaradura Infectious Diseases Institute
name: Nakornping Hospital
name: Prapokklao Hospital
name: Surin Hospital
name: Sappasitthiprasong Hospital
name: UdonThani Hospital
name: Buddhachinaraj Hospital
name: Phrachomklao Hospital
First posted: 2011-03-02
Enrollment: 199
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. HIV infection children age \< 18 years old
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:

1. Relevant history or current condition of PI resistance, plasma HIV RNA \> 1000 copies/ml after received the PI regimens for at least 6 months
2. On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir
3. On double boosted protease inhibitors

Primary outcomes:
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
timeFrame: 48 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
city: Chantaburi
country: Thailand
facility: Prapokklao Hospital
city: Chiang Mai
country: Thailand
facility: Nakornping Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Institute
city: Petchaburi
country: Thailand
facility: Phrachomklao Hospital
city: Pitsanulok
country: Thailand
facility: Buddhachinaraj Hospital
city: Surin
country: Thailand
facility: Surin Hospital
city: Ubonratchathani
country: Thailand
facility: Sappasitthiprasong Hospital
city: Udonthani
country: Thailand
facility: Udonthani Hospital
Study officials:
affiliation: Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT
name: Thanyawee Puthanakit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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