Atazavanir/Ritonavir-based HAART in Children

The HIV Netherlands Australia Thailand Research Collaboration20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Department of Pediatrics Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

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

Bangkok, Thailand

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

Bangkok, Thailand

Outcomes

Primary Outcomes

pharmacokinetics of atazanavir/ritonavir (ATV/r)

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

Time frame: 48 weeks

Secondary Outcomes

CD4

Assess CD percent and count at week 48

Time frame: 48 weeks

plasma viral load (HIV RNA)

assess HIV RNA at week 24 and 48

Time frame: 48 weeks

hyperbilirubin

evaluate total and direct bilirubin at weeks 24 and 48

Time frame: 48 weeks

Data from ClinicalTrials.gov

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