CHAPAS-2

Not Applicable

• Conditions: HIV/AIDS; Paediatrics

• Registration Number: PACTR201103000279108
• Lead Sponsor: Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1) HIV infected infants aged 3 months to <12 months currently taking or about to start LPV/r syrup based first-line following WHO guidelines 2008 [7].

OR

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.

OR

HIV infected infants aged 1 to 4 years currently taking or about to start LPV/r syrup based first-line

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 enrolment 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