HIVPhase 2NCT01656109
Atazavanir/Ritonavir-based HAART in Children
A Phase 2 study testing boosted atazanavir (ATV/r) in people with HIV, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- HIV
- What is being tested?
- boosted atazanavir (ATV/r)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesThailand
- Study dates
- Jul 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Department of Pediatrics Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330
Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok
About this study
Official title: The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children
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.
Read the 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.
- Conditions
- HIV
- Being tested
- boosted atazanavir (ATV/r)
- Keywords
- pharmacokinetics, atazanavir/ritonavir, HIV-infected children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| PI-experience group | Experimental | 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 Receives: Drug: boosted atazanavir (ATV/r) |
| PI-naïve group | Experimental | Never been exposed to any PI-containing regimen HIV-RNA viral load ≥ 1,000 copies/ml at the screening visit Receives: Drug: boosted atazanavir (ATV/r) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics of atazanavir/ritonavir (ATV/r)
Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed
Measured: 48 weeks
Secondary outcomes (3)
CD4
Assess CD percent and count at week 48
Measured: 48 weeks
plasma viral load (HIV RNA)
assess HIV RNA at week 24 and 48
Measured: 48 weeks
hyperbilirubin
evaluate total and direct bilirubin at weeks 24 and 48
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research, National Health Security Office, Thailand, The Thai Government Pharmaceutical Organization (GPO)
- Responsible party
- Sponsor
- Investigators
- Torsak Bunupuradah, MD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656109
- Sponsor's protocol ID
- HIV-NAT 146
- Status last verified
- Aug 2014
- First submitted
- 17 Jul 2012
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24983717
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children
- ClinicalTrials.gov ID
- NCT01656109
- Acronym / sponsor ID
- HIV-NAT 146
- Conditions
- HIV
- Keywords
- pharmacokinetics, atazanavir/ritonavir, HIV-infected children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research, National Health Security Office, Thailand, The Thai Government Pharmaceutical Organization (GPO)
- Study start
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PI-experience group | Experimental | Drug: boosted atazanavir (ATV/r)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 |
| PI-naïve group | Experimental | Drug: boosted atazanavir (ATV/r)Never been exposed to any PI-containing regimen HIV-RNA viral load ≥ 1,000 copies/ml at the screening visit |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | PI-experience group, PI-naïve group |
Primary outcome
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
3 secondary outcomes
CD4
Time frame: 48 weeks
plasma viral load (HIV RNA)
Time frame: 48 weeks
hyperbilirubin
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
- Results publication: PubMed 24983717Bunupuradah 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.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsak Bunupuradah, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing boosted atazanavir (ATV/r) in people with HIV, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetics of atazanavir/ritonavir (ATV/r) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01656109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.