Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children

Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01982396

Acronym

PENTA 13

Enrollment

Registered

2013-11-13

Start date

2003-01-31

Completion date

2004-03-31

Last updated

2013-11-13

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

Conditions

HIV Infection

Keywords

HIV, paediatric, Abacavir, lamivudine

Brief summary

Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.

Interventions

DRUGABC Twice Daily

DRUGABC Once Daily

DRUG3TC Once Daily

DRUG3TC Twice Daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 13 Years

Healthy volunteers

Inclusion criteria

* Children with definitive HIV infection * Age \> 2 and \< 13 years * Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.

Exclusion criteria

* • Intercurrent illness * Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP) * Abnormal renal or liver function (grade 3 or above)

Design outcomes

Primary

Measure	Time frame
Cmax of abacavir after qd and bid dosing	week 0 and week 4
AUC of abacavir after qd and bid dosing	week 0 and week 4
Cmin of abacavir after qd and bid dosing	week 0 and week 4
Area Under Curve (AUC) of lamivudine after qd and bid dosing	week 0 and Week 4
Cmin of lamivudine after qd and bid dosing	week 0 and week 4
Cmax of lamivudine after qd and bid dosing	week 0 and week 4

Secondary

Measure	Time frame
To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens	Week 0 and week 4

Other

Measure	Time frame
To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing	week -2 and week 24

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026