Overview

Abacavir and Lamivudine PK in Children

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators:
amfAR, The Foundation for AIDS Research
Chulalongkorn University
PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University
Radboud University
ViiV Healthcare
Treatments:
Abacavir
Dideoxynucleosides
Lamivudine
Criteria
Inclusion Criteria:

1. Have a diagnosis of HIV infection using age-appropriate testing

2. Age < 18 years

3. Body weight ≥ 14 kgs

4. Currently treated with stable HAART within 30 days prior to enrollment

5. HIV RNA < 50 copies/ml

6. Have negative HLA B5701 or are currently on ABC-containing HAART and tolerating the
regimen well

7. Caregivers give written informed consent and children aged 7 years and above who know
their HIV status give assent

Exclusion Criteria:

1. Child/Caretaker refuse to participate in this study

2. 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

3. 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

4. Has current active HIV-related infection

5. Has significant medical problem that would compromise the study results in the
investigator's opinion

6. Pregnancy

7. Has history of poor adherence to ARV defined by less than 80% by pill count or by
history within 30 days prior to enrollment

8. Concomitant treatment with drugs known to influence the PK of ABC (ribavirin, ethanol
and methadone)