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

HIV Infection Clinical Trial

— PENTA 13  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982396
• Other study ID #: PENTA 13
• Status: Completed
• Phase: Phase 1
• First received: October 25, 2013
• Last updated: November 5, 2013
• Start date: January 2003
• Est. completion date: March 2004

Study information

• Verified date: November 2013
• Source: PENTA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 13 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections

Intervention

Drug:
• ABC Twice Daily

• ABC Once Daily

• 3TC Once Daily

• 3TC Twice Daily

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital	London
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
PENTA Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, Le Prevost M, Walker S, Novelli V, Lyall H, Khoo S, Gibb D; PENTA-13 Study Group. Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13). Antivir Ther. 2005;10(2):239-46. — View Citation

LePrevost M, Green H, Flynn J, Head S, Clapson M, Lyall H, Novelli V, Farrelly L, Walker AS, Burger DM, Gibb DM; Pediatric European Network for the Treatment of AIDS 13 Study Group. Adherence and acceptability of once daily Lamivudine and abacavir in human immunodeficiency virus type-1 infected children. Pediatr Infect Dis J. 2006 Jun;25(6):533-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing		week -2 and week 24	No
Primary	Area Under Curve (AUC) of lamivudine after qd and bid dosing		week 0 and Week 4	No
Primary	Cmin of lamivudine after qd and bid dosing		week 0 and week 4	No
Primary	Cmax of lamivudine after qd and bid dosing		week 0 and week 4	No
Primary	AUC of abacavir after qd and bid dosing		week 0 and week 4	No
Primary	Cmin of abacavir after qd and bid dosing		week 0 and week 4	No
Primary	Cmax of abacavir after qd and bid dosing		week 0 and week 4	No
Secondary	To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens		Week 0 and week 4	No

External Links

•   PENTA 13 publications and presentations