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

Completed

• Conditions: Human immunodeficiency virus (HIV); Infections and Infestations; Human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN01946535
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified