Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)

HIV-infected Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307124
• Other study ID #: HIV-NAT 152
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2011
• Last updated: March 23, 2015
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: March 2015
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-infected Children

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Thailand	Queen Sirikit National Institute of Child Health	Bangkok
Thailand	Prapokklao Hospital	Chantaburi
Thailand	Nakornping Hospital	Chiang Mai
Thailand	Srinagarind Hospital, Khon Kaen University	Khon Kaen
Thailand	Bamrasnaradura Institute	Nonthaburi
Thailand	Phrachomklao Hospital	Petchaburi
Thailand	Buddhachinaraj Hospital	Pitsanulok
Thailand	Surin Hospital	Surin
Thailand	Sappasitthiprasong Hospital	Ubonratchathani
Thailand	Udonthani Hospital	Udonthani

Sponsors (12)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Bamrasnaradura Infectious Diseases Institute, Buddhachinaraj Hospital, Chulalongkorn University, Nakornping Hospital, Phrachomklao Hospital, Prapokklao Hospital, Queen Sirikit National Institute of Child Health, Sappasitthiprasong Hospital, Srinagarind Hospital, Khon Kaen University, Surin Hospital, Udonthani Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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 Ju

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 week	Yes

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)