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

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase: Completed; Phase 3

Conditions: HIV-infected Children

Treatments: Drug: kaletra

Study type: Interventional

Funder types: Other

Identifiers

NCT01307124

HIV-NAT 152

Details and patient eligibility

About

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

Enrollment: 199 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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199 participants in 2 patient groups

standard dose

Active Comparator group

Description:

Arm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW \>35-50 kg 400/100 mg

Treatment:

Drug: kaletra

low dose

Experimental group

Description:

Arm 2:Low dose BW 25-35 kg 200/50 mg BW \>35-50 kg 300/75 mg

Treatment:

Drug: kaletra