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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004433-18-GB

Enrollment

Registered

2005-12-19

Start date

2006-02-13

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric HIV infection MedDRA version: 8 Level: PT Classification code 10020161

Interventions

Product Name: Ziagen Oral Solution Pharmaceutical Form: Oral solution INN or Proposed INN: Abacavir sulfate CAS Number: 188062-50-2 Curr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants and children with confirmed presence of HIV infection. Infants and children aged 3 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Intercurrent illness Receiving concomitant therapy except prophylactic antibiotics Abnormal renal or liver function (grade 3 or above)

Design outcomes

Primary

Measure	Time frame
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 3 –12 –24 -<36 months) To describe child and family acceptability of and adherence to once daily compared to twice daily dosage regimens of ABC and 3TC ;Primary end point(s): AUC, Cmin and Cmax values of ABC after QD and BID dosing.	—

Countries

Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026