Paediatric HIV Infections and Infestations Paediatric HIV
Conditions
Interventions
1. At week 0, while children enrolled in the study are on a twice-daily regimen containing ABC or ABC and 3TC, serial pharmacokinetic samples will be collected
2. Following collection of these samples
Sponsors
PENTA Foundation (Italy)
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: 1. Intercurrent illnesses 2. Receiving concomitant therapy except prophylactic antibiotics 3. Abnormal renal or liver function (grade 3 or above)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under curve (AUC), Cmin and Cmax values of ABC after once and twice daily dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. AUC, Cmin and Cmax values of 3TC after once and twice daily dosing 2. Assessment of adherence and satisfaction with twice and once daily dosage regimens, using questionnaires | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed