PLASMA PHARMACOKINETIC STUDY OF ONCE VERSUS TWICE DAILY ABACAVIR AS PART OF COMBINATION ANTIRETROVIRAL THERAPY IN CHILDREN WITH HIV-1 INFECTION AGED 3 MONTHS TO < 36 MONTHS

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

Infants and children with confirmed presence of HIV infection.

Infants and children aged 3 to <36 months

Parents able / willing to give consent

Currently on combination ART including ABC oral solution with or without 3TC oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks.

HIV-1 RNA viral load –either suppressed HIV-1 RNA viral load (i.e. <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 be still gaining benefit from the current regimen

CD4+ cell percent – children should have stable or rising CD4+ cell percent prior to study entry and their CD4+ cell percent should not be expected to fall within the next 12 weeks.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Intercurrent illness

Receiving concomitant therapy except prophylactic antibiotics

Abnormal renal or liver function (grade 3 or above)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare plasma pharmacokinetic parameters of once versus twice daily dosing of ABC in HIV-1 infected infants and children aged 3 months to <36 months.;<br> Secondary Objective: To compare plasma pharmacokinetic parameters of once versus twice daily dosing of 3TC in HIV-1 infected infants and children aged 3 months to <36 months who are receiving 3TC in combination with ABC.<br><br> To compare age-related differences in the pharmacokinetic parameters of once versus twice daily dosing of ABC and 3TC in infants and children in 3 age groups (ages >3 –<12 months, >12 –<24 months and >24 -<36 months)<br><br> To describe child and family acceptability of and adherence to once daily compared to twice daily dosage regimens of ABC and 3TC<br> ;Primary end point(s): AUC, Cmin and Cmax values of ABC after QD and BID dosing.

Secondary Outcome Measures

Name	Time	Method

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