Clinical trial NCT01656109: Atazavanir/Ritonavir-based HAART in Children
Official title: The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: pharmacokinetics
atazanavir/ritonavir
HIV-infected children
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: amfAR, The Foundation for AIDS Research
name: National Health Security Office, Thailand
name: The Thai Government Pharmaceutical Organization (GPO)
First posted: 2012-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART have been commonly prescribed as the first-line HAART for HIV-infected children in resource-limited settings. Protease inhibitor (PI)-based HAART are the recommended second-line regimen after failing NNRTI-based HAART. The most commonly used PI in Thailand is lopinavir/ritonavir (LPV/r). However, the metabolic complications of lopinavir/ritonaive (LPV/r) such as hyperlipidemia and lipodyrtrophy are common and a concern for HIV-infected children as it may contribute to the development of cardiovascular disease in the longer term. There are data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected adults but none in children. Furthermore, many studies in both adults and children have shown that different ethnicities can result in different pharmacokinetic response to antiretroviral drugs. As a result of this, this study investigated the efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Active opportunistic infection
2. Relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion.
3. 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.)
4. Pregnancy or lactating at screening visit
5. Liver diseases e.g. hepatitis B carrier, chronic hepatitis, cirrhosis
6. Inability to understand the nature and extent of the study and the procedures required.

Primary outcomes:
measure: pharmacokinetics of atazanavir/ritonavir (ATV/r)
timeFrame: 48 weeks
Secondary outcomes:
measure: CD4
timeFrame: 48 weeks
measure: plasma viral load (HIV RNA)
timeFrame: 48 weeks
measure: hyperbilirubin
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatrics Faculty of Medicine, Chulalongkorn University
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
city: Bangkok
country: Thailand
facility: Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Torsak Bunupuradah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.