Atazavanir/Ritonavir-based HAART in Children
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ClinicalTrials.gov Identifier: NCT01656109 |
Recruitment Status
:
Completed
First Posted
: August 2, 2012
Last Update Posted
: August 26, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: boosted atazanavir (ATV/r) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- pharmacokinetics of atazanavir/ritonavir (ATV/r) [ Time Frame: 48 weeks ]Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed
- CD4 [ Time Frame: 48 weeks ]Assess CD percent and count at week 48
- plasma viral load (HIV RNA) [ Time Frame: 48 weeks ]assess HIV RNA at week 24 and 48
- hyperbilirubin [ Time Frame: 48 weeks ]evaluate total and direct bilirubin at weeks 24 and 48

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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656109
Thailand | |
Department of Pediatrics Faculty of Medicine, Chulalongkorn University | |
Bangkok, Thailand, 10330 | |
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | |
Bangkok, Thailand, 10330 | |
Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University | |
Bangkok, Thailand |
Principal Investigator: | Torsak Bunupuradah, MD | The HIV Netherlands Australia Thailand Research Collaboration |
Additional Information:
Publications of Results:
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT01656109 History of Changes |
Other Study ID Numbers: |
HIV-NAT 146 |
First Posted: | August 2, 2012 Key Record Dates |
Last Update Posted: | August 26, 2014 |
Last Verified: | August 2014 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
pharmacokinetics atazanavir/ritonavir HIV-infected children |
Additional relevant MeSH terms:
Ritonavir Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |