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 - Once versus twice dails abacavir

• Conditions: Decreasing the frequency with which medication needs to be taken in a day is likely to increase convenience and to enhance adherence in HIV-1 infected children. A once daily dosing regimen of abacavir (ABC) and lamivudine (3TC) has been approved for adults and a pharmacokinetic study performed in HIV-1 infected children aged 2 to 12 years. However, almost no date are available in children < 3 years; MedDRA version: 8Level: PTClassification code 10020161

• Registration Number: EUCTR2005-004433-18-DE
• Lead Sponsor: Fondazione P E N T A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-27
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Eligibility: Children aged between 3 and <36 months who are currently on combination ART including ABC oral solution with or without 3TC oral solution They should have been taking this combination for at least 12 weeks and be 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)
?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
·Stable or rising CD4+ cell percent prior to study entry and 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

unstable viral load
hypersensitivity reaction to abacavir
children olden than 36 months
withdrawal of informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified