Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS-2)

Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS-2): an open, randomised, controlled, phase I, crossover trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01946535

Enrollment

Registered

2011-04-28

Start date

2011-04-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus [HIV] disease

Interventions

24 children (aged 4-13 years able to take paediatric LPV/r tablets and either currently receiving LPV/r or about to start LPV/r containing ART) in a (1:1) ratio to LPV/r either in sprinkle or tablet f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Human immunodeficiency virus (HIV) infected infants aged 3 months to < 12 months currently taking or about to start Lopinavir/ritonavir (LPV/r) syrup based first-line following WHO guidelines 2008 [7] or 2. HIV infected children able to swallow paediatric LPV/r tablets and aged 4-13 years and < 25Kg, currently taking or about to start LPV/r based second-line following WHO guidelines 2. Carers and children where appropriate, willing and able to give informed consent

Exclusion criteria

Exclusion criteria: Children: 1. Who are expected to change weight bands (i.e. change dose) after enrollment and before PK day at week 8 2. With anaemia (haemoglobin < 8.5g/dL) or liver enzymes grade 2 or higher 3. With illnesses that could influence the pharmacokinetics of the antiretroviral (ARV) drugs at week 4 and week 8 e.g. severe diarrhoea, vomiting, renal or liver disease 4. On concomitant medications that are known to interact with the ARV drugs

Design outcomes

Primary

Measure	Time frame
1. To determine the pharmacokinetics (PK) of ritonavir-boosted-lopinavir (LPV/r) in a twice daily paediatric co-formulated fixed dose sprinkle combination (Lopimune, Cipla pharmaceuticals) and compare it to LPV/r in a twice daily paediatric co-formulated fixed dose tablet combination (Cipla Pharmaceuticals), both with food, in HIV-infected African children aged 4-12 years 2. To determine the pharmacokinetics (PK) of ritonavir-boosted-lopinavir (LPV/r) in a twice daily paediatric co-formulated fixed dose sprinkle combination (Lopimune, Cipla pharmaceuticals) and compare it to LPV/r in a twice daily paediatric co-formulated syrup (Abbott Pharmaceuticals), both with food, in HIV-infected African infants under 1 year of age	—

Measure

Time frame

1. To determine the pharmacokinetics (PK) of ritonavir-boosted-lopinavir (LPV/r) in a twice daily paediatric co-formulated fixed dose sprinkle combination (Lopimune, Cipla pharmaceuticals) and compare it to LPV/r in a twice daily paediatric co-formulated fixed dose tablet combination (Cipla Pharmaceuticals), both with food, in HIV-infected African children aged 4-12 years 2. To determine the pharmacokinetics (PK) of ritonavir-boosted-lopinavir (LPV/r) in a twice daily paediatric co-formulated fixed dose sprinkle combination (Lopimune, Cipla pharmaceuticals) and compare it to LPV/r in a twice daily paediatric co-formulated syrup (Abbott Pharmaceuticals), both with food, in HIV-infected African infants under 1 year of age

—

Secondary

Measure	Time frame
1. To compare the formulation preferences of children and their carers in terms of sprinkle or tablets 2. To compare the formulation preferences of infants carers in terms of sprinkle or syrups 3. To evaluate the effects of age, sex, severity of illness and anthropometric measurements [weight-for-age, height-for-age, body mass index (BMI), middle upper arm circumference (MUAC) and malnutrition indices] on pharmacokinetic parameters for LPV/r in HIV-infected African children. Specifically, to examine whether malnutrition modifies the pharmacokinetic characteristics of boosted Protease Inhibitors (PIs).	—

Measure

Time frame

1. To compare the formulation preferences of children and their carers in terms of sprinkle or tablets 2. To compare the formulation preferences of infants carers in terms of sprinkle or syrups 3. To evaluate the effects of age, sex, severity of illness and anthropometric measurements [weight-for-age, height-for-age, body mass index (BMI), middle upper arm circumference (MUAC) and malnutrition indices] on pharmacokinetic parameters for LPV/r in HIV-infected African children. Specifically, to examine whether malnutrition modifies the pharmacokinetic characteristics of boosted Protease Inhibitors (PIs).

—

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026