Clinical Trials

MainTitle

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)

This study has been completed
Sponsor
PENTA Foundation


Information provided by (Responsible Party)
PENTA Foundation
ClinicalTrials.gov Identifier
NCT01982396

First received: October 25, 2013
Last updated: November 5, 2013
Last Verified: November 2013
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infection

Drug : ABC Twice Daily
Drug : ABC Once Daily
Drug : 3TC Once Daily
Drug : 3TC Twice Daily
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection

Further study details as provided by PENTA Foundation:

Primary Outcome Measures

  • Area Under Curve (AUC) of lamivudine after qd and bid dosing [ Time Frame: week 0 and Week 4 ]
  • Cmin of lamivudine after qd and bid dosing [ Time Frame: week 0 and week 4 ]
  • Cmax of lamivudine after qd and bid dosing [ Time Frame: week 0 and week 4 ]
  • AUC of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ]
  • Cmin of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ]
  • Cmax of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ]
Secondary Outcome Measures:
  • To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens [ Time Frame: Week 0 and week 4 ]
Other Outcome Measures:
  • To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing [ Time Frame: week -2 and week 24 ]

Enrollment: 19
Study Start Date: January 2003
Study Completion Date: March 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Twice daily

Drug: ABC Twice Daily
Drug: 3TC Twice Daily
Experimental: Once daily

Drug: ABC Once Daily
Drug: 3TC Once Daily
Eligibility

Eligibility

Ages Eligible for Study: 2 Years to 13 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982396

Locations

United Kingdom
Great Ormond Street Hospital
London, United Kingdom
St. Mary's Hospital
London, United Kingdom

Sponsors and Collaborators

PENTA Foundation

Investigators

Principal Investigator: Vas Novelli, MD Great Ormond Street Hospital for Children, London, UK
Principal Investigator: Hermione Lyall, MD St. Mary's Hospital, London, UK
More Information

More Information

Additional Information:

PENTA 13 publications and presentations

Responsible Party: PENTA Foundation  
ClinicalTrials.gov Identifier: NCT01982396   History of Changes  
Other Study ID Numbers: PENTA 13  
Study First Received: October 25, 2013  
Last Updated: November 5, 2013  

Keywords provided by PENTA Foundation:

HIV
paediatric
Abacavir
lamivudine

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lamivudine
Abacavir

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.