NCT01656109

Brief Summary

There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children. Therefore, the investigators aim to evaluate the pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 hiv

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2 hiv

Geographic Reach
1 country

3 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

July 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

Enrollment Period

1.6 years

First QC Date

July 17, 2012

Last Update Submit

August 25, 2014

Conditions

HIV

Keywords

pharmacokineticsatazanavir/ritonavirHIV-infected children

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics of atazanavir/ritonavir (ATV/r)

    Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed

    48 weeks

Secondary Outcomes (3)

  • CD4

    48 weeks

  • plasma viral load (HIV RNA)

    48 weeks

  • hyperbilirubin

    48 weeks

Study Arms (2)

PI-experience group

EXPERIMENTAL

Using PI-based HAART for ≥6 months at the screening visit HIV-RNA viral load \< 50 copies/ml at the screening visit No history of HIV-RNA ≥ 1,000 copies/ml while using PI-based HAART

Drug: boosted atazanavir (ATV/r)

PI-naïve group

EXPERIMENTAL

Never been exposed to any PI-containing regimen HIV-RNA viral load ≥ 1,000 copies/ml at the screening visit

Drug: boosted atazanavir (ATV/r)

Interventions

boosted atazanavir (ATV/r)DRUG

ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline

PI-experience groupPI-naïve group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV-infected children
  • Age from 6- 18 years old
  • Body weight ≥ 25 kg at screening visit
  • ARV history, the children can be categorized in one of these 2 groups
  • ALT \<200 IU/L at screening visit
  • Total bilirubin \< 3 mg/dL at the screening visit
  • Can swallow capsule
  • Written informed consent from caregivers and assent (from children aged 7-17 years who know their HIV status)

You may not qualify if:

  • Active opportunistic infection
  • Relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion.
  • Use of concomitant medication that may interfere with the pharmacokinetics of ATV/r (i.e. efavirenz, indinavir, proton pump inhibitor, antacids, cisapride, clarithromycin, rifampin etc.)
  • Pregnancy or lactating at screening visit
  • Liver diseases e.g. hepatitis B carrier, chronic hepatitis, cirrhosis
  • Inability to understand the nature and extent of the study and the procedures required.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Pediatrics Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

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

Bangkok, 10330, Thailand

Location

Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

Location

Related Publications (1)

  • Bunupuradah T, Techasaensiri C, Keadpudsa S, Thammajaruk N, Srimuan A, Sahakijpicharn T, Prasitsuebsai W, Ananworanich J, Puthanakit T; HIV-NAT 146 Study Team. Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking tenofovir disoproxil fumarate. Pediatr Infect Dis J. 2014 Dec;33(12):e316-9. doi: 10.1097/INF.0000000000000469.

    PMID: 24983717RESULT

Related Links

Study Officials

  • Torsak Bunupuradah, MD

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

August 2, 2012

Study Start

July 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 26, 2014

Record last verified: 2014-08

Locations

TH(3)