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
NCT ID: NCT01982396
Last Updated: 2013-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2003-01-31
2004-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Twice daily
ABC Twice Daily
3TC Twice Daily
Once daily
ABC Once Daily
3TC Once Daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABC Twice Daily
ABC Once Daily
3TC Once Daily
3TC Twice Daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP)
* Abnormal renal or liver function (grade 3 or above)
2 Years
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PENTA Foundation
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vas Novelli, MD
Role: PRINCIPAL_INVESTIGATOR
Great Ormond Street Hospital for Children, London, UK
Hermione Lyall, MD
Role: PRINCIPAL_INVESTIGATOR
St. Mary's Hospital, London, UK
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Great Ormond Street Hospital
London, , United Kingdom
St. Mary's Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
PENTA 13 publications and presentations
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PENTA 13
Identifier Type: -
Identifier Source: org_study_id