PENTA18: Pharmacokinetics, safety and efficacy of lopinavir/ritonavir tablets in combination antiretroviral therapy in human immunodeficiency virus-1 (HIV-1) infected childre

Phase 2

Completed

• Conditions: Infectious disease - Paediatric HIV; Infections and Infestations; Human immunodeficiency virus

• Registration Number: ISRCTN02452400
• Lead Sponsor: The PENTA Foundation (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-10
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Aged less than 18 years (up to 18th birthday) with confirmed HIV-1 infection, either sex
2. Weight greater than or equal to 15 kg
3. Able to swallow tablets
4. Stable (i.e. CD4 not declining) on a combination antiretroviral regimen that has included lopinavir/ritonavir for at least 24 weeks, and expected to stay on the same regimen for the next 48 weeks
5. Taking lopinavir/ritonavir dosed twice-daily and be willing at the screening visit to change to tablet formulation (if not currently taking tablets) and to change the lopinavir/ritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary; if participating in the PK study, be willing at the screening visit to change to lopinavir/ritonavir half strength formulation tablets (100/25 mg) only, dosed twice-daily and change the lopinavir/ritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary
6. Viral suppression (HIV-1 ribonucleic acid [RNA] less than 50 copies/ml) for at least the prior 24 weeks (minimum of two measurements)
7. Children and caregivers willing to participate in the PK study if they are among a minimum of the first 16 children enrolled in each body weight band in the trial, including a second PK assessment if randomised to switch to once-daily lopinavir/ritonavir
8. Parents/carers and children, where applicable, give informed written consent

Exclusion Criteria

1. Children on an antiretroviral regimen that includes a non-nucleoside reverse transcriptase inhibitor (NNRTI), fosamprenavir or nelfinavir
2. Children who have previously failed virologically on a protease inhibitor (PI)-containing regimen (where virological failure is defined as two successive HIV-1 ribonucleic acid [RNA] results greater than 1000 copies/ml [confirmed] more than 24 weeks after starting highly active anti-retroviral therapy [HAART], i.e changes for toxicity are not counted as failure)
3. Intercurrent illness
4. Abnormal renal or liver function (grade 3 or above)
5. Receiving concomitant therapy except prophylactic antibiotics
6. Pregnancy or risk of pregnancy in females of child-bearing potential

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. HIV-1 RNA greater than or equal to 400 copies/ml (confirmed) at any of week 4, 8, 12, 24, 36 or 48<br>2. Area under curve (AUC), Cmin and Cmax values of lopinavir after twice-daily dosing compared to historical adult and paediatric data<br>3. AUC, Cmin and Cmax values of lopinavir after once-daily and twice-daily dosing (in the same children)