ISRCTN38147516
Completed
Not Applicable
Plasma pharmacokinetic study of once versus twice daily abacavir as part of combination antiretroviral therapy in children with human immunodeficiency virus-1 infection aged 3 months to less than 36 months
PENTA Foundation (Italy)0 sites18 target enrollmentJanuary 17, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paediatric HIV
- Sponsor
- PENTA Foundation (Italy)
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Infants and children with confirmed presence of human immunodeficiency virus (HIV\-1\) infection
- •2\. Infants and children aged 3 to less than 36 months
- •3\. Parents able/willing to give consent
- •4\. Currently on combination anti\-retroviral therapy (ART) including ABC oral solution or a combination of ABC and 3TC, for at least 12 weeks, and expected to stay on this regimen for at least a further 12 weeks
- •5\. HIV\-1 ribonucleic acid (RNA) viral load \- either suppressed HIV\-1 RNA viral load (i.e. less than 400 copies/ml) or non\-suppressed but low HIV\-1 RNA viral load (i.e. 400 \- 20,000 copies/ml). The non\-suppressed children should have had a stable or decreasing HIV\-1 RNA viral load prior to study entry and should be considered to still be gaining benefit from the current regimen.
- •6\. Children should have stable or rising cluster of differentiation\-4 (CD4\+) cell percentage prior to study entry and their CD4\+ cell percentage should not be expected to fall within the next 12 weeks
Exclusion Criteria
- •1\. Intercurrent illnesses
- •2\. Receiving concomitant therapy except prophylactic antibiotics
- •3\. Abnormal renal or liver function (grade 3 or above)
Outcomes
Primary Outcomes
Not specified
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