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Clinical Trials/ISRCTN01946535
ISRCTN01946535
Completed
Not Applicable

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

Medical Research Council (UK)0 sites40 target enrollmentApril 28, 2011
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ConditionsHuman immunodeficiency virus (HIV)Infections and InfestationsHuman immunodeficiency virus [HIV] disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human immunodeficiency virus (HIV)
Sponsor
Medical Research Council (UK)
Enrollment
40
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 28, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Medical Research Council (UK)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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