HIV InfectionsNCT00477308
Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
A study testing salvage therapy in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
Trial summary
In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- salvage therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 3 sitesThailand
- Study dates
- Jan 2006to Apr 2009
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children from HIV-NAT 013 phase I
Who cannot join
- No inform consent obtained
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Chulalongkorn Hospital
Bangkok, 10330
Queen Sirikit National Institute of Child Health, Bangkok
Bangkok, 10330
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330
About this study
Official title: Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.
Read the detailed description
The HIV-NAT 013 study (conducted in 2003) evaluated prevalence and pattern of RT mutation in 95 children treated with dual NRTI. The study showed almost all children to have some degree of NRTI resistance and 40% with multi NRTI resistance. The mutation reported was major mutation.
After the study, the patients were managed based on the physician's judgment using genotyping results. The 95 patients in HIV-NAT 013 are categorized into 3 groups.
- No viral resistance
- Low grade resistance with or without clinical/ immunological failure
- High grade resistance with or without clinical/ immunological failure.
There are limited prospective studies evaluating outcome of decision regarding salvage therapy after genotyping results
There are also new mutations that are not considered major mutation that may affect treatment outcome
Knowledge learned from this study will benefit Thai children with NRTI resistance by helping pediatricians better choose salvage treatment options
- Conditions
- HIV Infections
- Being tested
- salvage therapy
- Keywords
- HIV children, genotypic resistance, dual NRTIs, Salvage therapy, treatment outcome, Salvage therapy based on genotyping results, Treatment Failure
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salvage therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| salvage therapy | Other | Children with drug resistance were treated using the drug resistant profile Receives: Procedure: salvage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy
Measured: 1 time point (Cross Sectional Study)
Secondary outcomes (3)
Comparison outcome of children in the 3 groups,
Measured: 1 time point
Changes of mutation in children within the 3 groups, and
Measured: 1 time point
Effect of previously unreported mutations, minor and others, on treatment outcome
Measured: 1 time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startJan 2006
- Primary completionApr 2009
- Study completionApr 2009
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 HIV InfectionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- salvage therapy
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Cohort
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Tawee Chotpitayasunondh, MD, Principal investigator, Queen Sirikit National Institute of Child Health, Bangkok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477308
- Sponsor's protocol ID
- HIV-NAT 013 phase II
- Status last verified
- Jul 2020
- First submitted
- 20 May 2007
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bunupuradah T, Suntarattiwong P, Li A, Sirivichayakul S, Pancharoen C, Boonrak P, Puthanakit T, Kerr SJ, Ruxrungtham K, Chotpitayasunondh T, Hirschel B, Ananworanich J; HIV-NAT 013 Study Team. Antiretroviral treatment outcome following genotyping in Thai children who failed dual nucleoside reverse transcriptase inhibitors. Int J Infect Dis. 2010 Apr;14(4):e311-6. doi: 10.1016/j.ijid.2009.05.017. Epub 2009 Aug 21.
PubMed 19699673
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
- Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
- ClinicalTrials.gov ID
- NCT00477308
- Acronym / sponsor ID
- HIV-NAT 013 phase II
- Conditions
- HIV Infections
- Keywords
- HIV children, genotypic resistance, dual NRTIs, Salvage therapy, treatment outcome, Salvage therapy based on genotyping results, Treatment Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Swiss Cohort
- Study start
- Jan 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 May 2007 (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.
In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.
Detailed description
The HIV-NAT 013 study (conducted in 2003) evaluated prevalence and pattern of RT mutation in 95 children treated with dual NRTI. The study showed almost all children to have some degree of NRTI resistance and 40% with multi NRTI resistance. The mutation reported was major mutation.
After the study, the patients were managed based on the physician's judgment using genotyping results. The 95 patients in HIV-NAT 013 are categorized into 3 groups.
- No viral resistance
- Low grade resistance with or without clinical/ immunological failure
- High grade resistance with or without clinical/ immunological failure.
There are limited prospective studies evaluating outcome of decision regarding salvage therapy after genotyping results
There are also new mutations that are not considered major mutation that may affect treatment outcome
Knowledge learned from this study will benefit Thai children with NRTI resistance by helping pediatricians better choose salvage treatment options
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- salvage therapy
| Arm | Type | Receives |
|---|---|---|
| salvage therapy | Other | Procedure: salvage therapyChildren with drug resistance were treated using the drug resistant profile |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children from HIV-NAT 013 phase I
Key exclusion criteria (1 listed)
- No inform consent obtained
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 |
|---|---|---|
| salvage therapy | Procedure or surgery | salvage therapy |
Primary outcome
Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy
Time frame: 1 time point (Cross Sectional Study)
3 secondary outcomes
Comparison outcome of children in the 3 groups,
Time frame: 1 time point
Changes of mutation in children within the 3 groups, and
Time frame: 1 time point
Effect of previously unreported mutations, minor and others, on treatment outcome
Time frame: 1 time point
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 19699673Bunupuradah T, Suntarattiwong P, Li A, Sirivichayakul S, Pancharoen C, Boonrak P, Puthanakit T, Kerr SJ, Ruxrungtham K, Chotpitayasunondh T, Hirschel B, Ananworanich J; HIV-NAT 013 Study Team. Antiretroviral treatment outcome following genotyping in Thai children who failed dual nucleoside reverse transcriptase inhibitors. Int J Infect Dis. 2010 Apr;14(4):e311-6. doi: 10.1016/j.ijid.2009.05.017. Epub 2009 Aug 21.
- The 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.
Kiat Ruxrungtham, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Tawee Chotpitayasunondh, MD principal investigator
Queen Sirikit National Institute of Child Health, Bangkok
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salvage therapy in people with HIV Infections, 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 1 inclusion and 1 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 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.
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?
Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy (time frame: 1 time point (Cross Sectional Study)). 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 NCT00477308, 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.