This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV TherapyNCT01225406
Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
An observational study of This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy, run by The HIV Netherlands Australia Thailand Research Collaboration at 9 sites in Thailand.
Trial summary
This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy
- What is being tested?
- Tenofovir
- How many people
- 56 participants
- Where
- 9 sitesThailand
- Study dates
- Aug 2010to Dec 2013
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Thai children aged < 18 years old who are on or are switching to third line antiretroviral therapy
Who may be able to join
- Children (< 18 years old) with HIV infection may enroll if one of the following criteria is met:
- Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA > 1000 copies/ml prior to switching to third line ARV therapy
- Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir
Who cannot join
- Have hepatic impairment with ALT ≥ 5 upper limit of normal
- Pregnant or breastfeeding
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Thailand9 sites
Chulalongkorn University
Bangkok, 10330
HIV-NAT
Bangkok, 10330
Siriraj Hospital, Mahidol University
Bangkok, 10700
Prapokklao Chantaburi
Chanthaburi, Changwat Chanthaburi, 22000
Nakornping Hospital
Chiang Mai, 50180
Chiang Rai Regional Hospital
Chiang Rai, 57000
Khon Kaen University
Khon Kaen, 40002
Bamrasnaradura Institute
Nonthaburi, 11000
Surin Hospital
Surin, 32000
About this study
Official title: Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy
This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will help the Thai government in planning its strategy to provide third line ARV therapy to children within the national program.
Read the detailed description
The primary objective of this study is to assess the virological efficacy, as measured by the proportions of children with HIV RNA below 400 and 50 copies/ml at 48 weeks after initiating third line ARV therapy.
Third line ARV therapy is defined as an ARV regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir
- Conditions
- This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy
- Being tested
- Tenofovir
- Keywords
- Third line ARV therapy, HIV RNA, Absolute CD4+ T cell count, serious adverse events (SAEs), Drug resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
| Study group | Role | What they receive |
|---|---|---|
| third line naive | Children on second line or other regimen who switch or start third line regimen Receives: Drug: Tenofovir | |
| third line experienced | children who are on third line regimen Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
undetectable viral load
Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.
Measured: 48 weeks
Secondary outcomes (1)
Hyperlipidemia
Number of subjects with hyperlipidemia as a measure of safety
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 posted21 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionDec 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 This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Thailand, National Health Security Office, Thailand
- Responsible party
- Sponsor
- Investigators
- Thanyawee Puthanakit, MD, Principal investigator, Chulalongkorn UniversityKulkanya Chokephaibulkit, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225406
- Sponsor's protocol ID
- HIV-NAT 113
- Status last verified
- Jul 2020
- First submitted
- 18 Oct 2010
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol O, Gorowara M, Phongsamart W, Sophonphan J, Kerr SJ, Vanprapar N, Puthanakit T, Pasomsap C, Suwanlerk T, Sekar V, Burger D, Ananworanich J; HIV-NAT 113 Pharmacokinetic Study Group. Pharmacokinetics of darunavir/ritonavir in Asian HIV-1-infected children aged >/=7 years. Antivir Ther. 2012;17(7):1263-9. doi: 10.3851/IMP2347. Epub 2012 Sep 6.
PubMed 22954687
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT01225406
- Acronym / sponsor ID
- HIV-NAT 113
- Conditions
- This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy
- Keywords
- Third line ARV therapy, HIV RNA, Absolute CD4+ T cell count, serious adverse events (SAEs), Drug resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Ministry of Education, Thailand, National Health Security Office, Thailand
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Oct 2010 (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.
This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will help the Thai government in planning its strategy to provide third line ARV therapy to children within the national program.
Detailed description
The primary objective of this study is to assess the virological efficacy, as measured by the proportions of children with HIV RNA below 400 and 50 copies/ml at 48 weeks after initiating third line ARV therapy.
Third line ARV therapy is defined as an ARV regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| third line naive | – | Drug: TenofovirChildren on second line or other regimen who switch or start third line regimen |
| third line experienced | – | Drug: Tenofovirchildren who are on third line regimen |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Thai children aged < 18 years old who are on or are switching to third line antiretroviral therapy
Key inclusion criteria (3 listed)
- Children (< 18 years old) with HIV infection may enroll if one of the following criteria is met:
- Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA > 1000 copies/ml prior to switching to third line ARV therapy
- Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir
Key exclusion criteria (2 listed)
- Have hepatic impairment with ALT ≥ 5 upper limit of normal
- Pregnant or breastfeeding
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 |
|---|---|---|
| Tenofovir | Drug | third line experienced, third line naive |
Primary outcome
undetectable viral load
Time frame: 48 weeks
Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.
1 secondary outcome
Hyperlipidemia
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 17 Jul 2020.
- Results publication: PubMed 22954687Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol O, Gorowara M, Phongsamart W, Sophonphan J, Kerr SJ, Vanprapar N, Puthanakit T, Pasomsap C, Suwanlerk T, Sekar V, Burger D, Ananworanich J; HIV-NAT 113 Pharmacokinetic Study Group. Pharmacokinetics of darunavir/ritonavir in Asian HIV-1-infected children aged >/=7 years. Antivir Ther. 2012;17(7):1263-9. doi: 10.3851/IMP2347. Epub 2012 Sep 6.
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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.
Thanyawee Puthanakit, MD principal investigator
Chulalongkorn University
Kulkanya Chokephaibulkit, MD principal investigator
Siriraj Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy, run by The HIV Netherlands Australia Thailand Research Collaboration at 9 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 3 inclusion and 2 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
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?
undetectable viral load (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 NCT01225406, 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 17 Jul 2020.