Abacavir and Lamivudine PK in Children

NCT01656122 | Completed Phase 2

• 1 other identifier: HIV-NAT 167
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetic parameters for ABC and 3TC in HIV-infected children younger than 18 years old with body weight ≥ 14 kgs.

Conditions

HIV

Keywords

pharmacokinetic paramters; abacavir; lamuvidine; HIV-infected children

Outcome Measures

Primary Outcomes (1)

• Ctrough and Area under the curve (AUC) of abacavir (ABC) and lamivudine (3TC) at week 2 and 4

  assess the Ctrough and Area under the curve (AUC) of abacavir (ABC) and lamivudine (3TC) at week 2 twice daily dose and week 4 once daily dose

  week 96

Secondary Outcomes (2)

• CD4

  96 weeks

• viral load

  96 weeks

Study Arms (1)

PK

EXPERIMENTAL

PK of abacavir and lamivudine

Drug: abacavir; Drug: 3TC

Interventions

abacavir DRUG

Dosing of ABC will be according to the WHO guidelines by weight band for twice daily dosing. The once daily dosing will use the same mg/day as the twice daily dosing for that weight band

PK

3TC DRUG

Dosing of 3TC will be according to the WHO guidelines by weight band for twice daily dosing. The once-daily dosing will use the same mg/day as the twice-daily dosing for that weight band

PK

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have a diagnosis of HIV infection using age-appropriate testing
• Age \< 18 years
• Body weight ≥ 14 kgs
• Currently treated with stable HAART within 30 days prior to enrollment
• HIV RNA \< 50 copies/ml
• Have negative HLA B5701 or are currently on ABC-containing HAART and tolerating the regimen well
• Caregivers give written informed consent and children aged 7 years and above who know their HIV status give assent

You may not qualify if:

• Child/Caretaker refuse to participate in this study
• Has vomiting or diarrhea \> grade 3 (DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0 - December 2004, clarification dated August 2009) within 30 days prior to enrollment
• Has the following laboratory toxicities \> grade II according to the division of AIDS table for grading the severity of adult and pediatric adverse events within 30 days prior to enrollment:
• SGPT
• Hemoglobin
• Creatinine
• Has current active HIV-related infection
• Has significant medical problem that would compromise the study results in the investigator's opinion
• Pregnancy
• Has history of poor adherence to ARV defined by less than 80% by pill count or by history within 30 days prior to enrollment
• Concomitant treatment with drugs known to influence the PK of ABC (ribavirin, ethanol and methadone)

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Radboud University Medical Center: collaborator
• amfAR, The Foundation for AIDS Research: collaborator
• PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University: collaborator
• Chulalongkorn University: collaborator
• ViiV Healthcare: collaborator

Study Sites (1)

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Bangkok, 10330, Thailand

Location

Related Publications (1)

• Bunupuradah T, Punyahotra P, Cressey TR, Srimuan A, Thammajaruk N, Sophonphan J, Sriheara C, Burger DM, Puthanakit T, Ananworanich J. Plasma pharmacokinetics of once-daily abacavir- and lamivudine-containing regimens and week 96 efficacy in HIV-infected Thai children. J Virus Erad. 2015 Jul 1;1(3):185-91. doi: 10.1016/S2055-6640(20)30503-3.

  PMID: 27482411 RESULT

Related Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

MeSH Terms

Interventions

abacavir

Study Officials

• Jintanat Ananworanich, MD, PhD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

TH (1)