NCT01982396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

October 25, 2013

Last Update Submit

November 5, 2013

Conditions

HIV Infection

Keywords

HIVpaediatricAbacavirlamivudine

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • Cmax of abacavir after qd and bid dosing

    week 0 and week 4

Secondary Outcomes (1)

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

    Week 0 and week 4

Other Outcomes (1)

  • To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing

    week -2 and week 24

Study Arms (2)

Twice daily

ACTIVE COMPARATOR
Drug: ABC Twice DailyDrug: 3TC Twice Daily

Once daily

EXPERIMENTAL
Drug: ABC Once DailyDrug: 3TC Once Daily

Interventions

ABC Twice DailyDRUG
Twice daily
ABC Once DailyDRUG
Once daily
3TC Once DailyDRUG
Once daily
3TC Twice DailyDRUG
Twice daily

Eligibility Criteria

Age2 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Great Ormond Street Hospital

London, United Kingdom

Location

St. Mary's Hospital

London, United Kingdom

Location

Related 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.

    PMID: 15865218BACKGROUND

  • 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.

    PMID: 16732152BACKGROUND

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Vas Novelli, MD

    Great Ormond Street Hospital for Children, London, UK

    PRINCIPAL INVESTIGATOR

  • Hermione Lyall, MD

    St. Mary's Hospital, London, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 13, 2013

Study Start

January 1, 2003

Primary Completion

February 1, 2004

Study Completion

March 1, 2004

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

GB(2)