HIV
Conditions
Keywords
pharmacokinetics, atazanavir/ritonavir, HIV-infected children
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.
Interventions
DRUGboosted atazanavir (ATV/r)
ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline
Sponsors
amfAR, The Foundation for AIDS Research
National Health Security Office, Thailand
The Thai Government Pharmaceutical Organization (GPO)
The HIV Netherlands Australia Thailand Research Collaboration
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacokinetics of atazanavir/ritonavir (ATV/r) | 48 weeks | Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4 | 48 weeks | Assess CD percent and count at week 48 |
| plasma viral load (HIV RNA) | 48 weeks | assess HIV RNA at week 24 and 48 |
| hyperbilirubin | 48 weeks | evaluate total and direct bilirubin at weeks 24 and 48 |
Countries
Thailand
Outcome results
None listed