search
Back to results

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 (PENTA 13)

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ABC Twice Daily
ABC Once Daily
3TC Once Daily
3TC Twice Daily
Sponsored by
PENTA Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, paediatric, Abacavir, lamivudine

Eligibility Criteria

2 Years - 13 Years (Child)All SexesDoes not accept 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)

Sites / Locations

  • Great Ormond Street Hospital
  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Twice daily

Once daily

Arm Description

Outcomes

Primary Outcome Measures

Area Under Curve (AUC) of lamivudine after qd and bid dosing
Cmin of lamivudine after qd and bid dosing
Cmax of lamivudine after qd and bid dosing
AUC of abacavir after qd and bid dosing
Cmin of abacavir after qd and bid dosing
Cmax of abacavir after qd and bid dosing

Secondary Outcome Measures

To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens

Full Information

First Posted
October 25, 2013
Last Updated
November 5, 2013
Sponsor
PENTA Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01982396
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PENTA Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, paediatric, Abacavir, lamivudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twice daily
Arm Type
Active Comparator
Arm Title
Once daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ABC Twice Daily
Intervention Type
Drug
Intervention Name(s)
ABC Once Daily
Intervention Type
Drug
Intervention Name(s)
3TC Once Daily
Intervention Type
Drug
Intervention Name(s)
3TC Twice Daily
Primary Outcome Measure Information:
Title
Area Under Curve (AUC) of lamivudine after qd and bid dosing
Time Frame
week 0 and Week 4
Title
Cmin of lamivudine after qd and bid dosing
Time Frame
week 0 and week 4
Title
Cmax of lamivudine after qd and bid dosing
Time Frame
week 0 and week 4
Title
AUC of abacavir after qd and bid dosing
Time Frame
week 0 and week 4
Title
Cmin of abacavir after qd and bid dosing
Time Frame
week 0 and week 4
Title
Cmax of abacavir after qd and bid dosing
Time Frame
week 0 and week 4
Secondary Outcome Measure Information:
Title
To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens
Time Frame
Week 0 and week 4
Other Pre-specified Outcome Measures:
Title
To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing
Time Frame
week -2 and week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vas Novelli, MD
Organizational Affiliation
Great Ormond Street Hospital for Children, London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hermione Lyall, MD
Organizational Affiliation
St. Mary's Hospital, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital
City
London
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15865218
Citation
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.
Results Reference
background
PubMed Identifier
16732152
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. doi: 10.1097/01.inf.0000222415.40563.d4.
Results Reference
background
Links:
URL
http://www.penta-id.org/hiv/penta-trials/penta-trials-publications/49-penta-13.html
Description
PENTA 13 publications and presentations

Learn more about this trial

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

We'll reach out to this number within 24 hrs