Atazavanir/Ritonavir-based HAART in Children
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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.
Condition | Intervention | Phase |
---|---|---|
HIV |
Drug: boosted atazanavir (ATV/r) |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children |
- pharmacokinetics of atazanavir/ritonavir (ATV/r) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed
- CD4 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]Assess CD percent and count at week 48
- plasma viral load (HIV RNA) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]assess HIV RNA at week 24 and 48
- hyperbilirubin [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]evaluate total and direct bilirubin at weeks 24 and 48
Estimated Enrollment: | 20 |
Study Start Date: | July 2011 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: PI-experience group
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)
ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline
|
Experimental: PI-naïve group
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)
ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline
|
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.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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: Torsak Bunupuradah, MD | 662-652-3040 | torsak.b@hivnat.org |
Thailand | |
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | Recruiting |
Bangkok, Thailand, 10330 | |
Contact: Torsak Bunupuradah, MD 662-652-3040 torsak.b@hivnat.org | |
Contact: Wasana Prasitsuebsai, MD 662-652-3040 wasana.p@hivnat.org | |
Principal Investigator: Torsak Bunupuradah, MD | |
Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University | Recruiting |
Bangkok, Thailand | |
Contact: Chonnamet Techasaensiri, MD chonmet@yahoo.com | |
Principal Investigator: Chonnamet Techasaensiri, MD | |
Department of Pediatrics Faculty of Medicine, Chulalongkorn University | Recruiting |
Bangkok, Thailand, 10330 | |
Contact: Thanyawee Puthanakit, MD 662-652-3040 thanyawee.p@hivnat.org | |
Principal Investigator: Thanyawee Puthanakit, MD |
Principal Investigator: | Torsak Bunupuradah, MD | The HIV Netherlands Australia Thailand Research Collaboration |
Additional Information:
No publications provided
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT01656109 History of Changes |
Other Study ID Numbers: | HIV-NAT 146 |
Study First Received: | July 17, 2012 |
Last Updated: | July 31, 2012 |
Health Authority: | Thailand: Ethical Committee |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
pharmacokinetics atazanavir/ritonavir HIV-infected children |
Additional relevant MeSH terms:
Ritonavir Atazanavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 14, 2013