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
- Conditions
- Paediatric HIVInfections and Infestations
- Registration Number
- ISRCTN38147516
- Lead Sponsor
- PENTA Foundation (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
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
1. Intercurrent illnesses
2. Receiving concomitant therapy except prophylactic antibiotics
3. Abnormal renal or liver function (grade 3 or above)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under curve (AUC), Cmin and Cmax values of ABC after once and twice daily dosing
- Secondary Outcome Measures
Name Time Method 1. AUC, Cmin and Cmax values of 3TC after once and twice daily dosing<br>2. Assessment of adherence and satisfaction with twice and once daily dosage regimens, using questionnaires