HIVNCT04489953
Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda
A study testing Viral Load in people with HIV, run by MU-JHU CARE.
Trial summary
The main goal was to compare clinical and immunological versus clinical, immunological plus viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes, including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses for treatment experienced children… Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Viral Load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 16 Jan 2017
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- HIV-Infected Children, 1 year to 12 years
- ART experienced and enrolled in an existing treatment program that used clinical and immunologic criteria to monitor response to ART.
Who cannot join
- None
About this study
Official title: Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children
The main goal was to compare clinical and immunological versus clinical, immunological plus viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes, including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses for treatment experienced children randomized to two switching criteria.
Read the detailed description
The overall goal of the study was aimed at determining whether the use of the current WHO criteria alone (clinical and immunologic) to define treatment failure as the trigger for switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month treatment outcomes when compared to combining clinical and immunologic parameters with viral load (VL) monitoring.
In addition the study aimed at obtaining plasma samples from treatment experienced children, for future resistance testing. The results of this study may help guide WHO and national pediatric ART programs on the need for routine VL monitoring for children initiating HAART in resource limited settings, where virologic tests including resistance testing are not readily available or affordable.
- Conditions
- HIV
- Being tested
- Viral Load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viral LoadOther
For the Clinical and Immunologic criteria, viral load was done retrospectively on stored plasma samples. Whereas for the Clinical, Immunologic and Virologic criteria, viral load was done in real-time
| Study group | Role | What they receive |
|---|---|---|
| Clinical and Immunologic criteria | Active comparator | In the clinical and immunologic monitoring criteria was based on the 2010 WHO guidelines. Whereby children were monitored using clinical presentation and CD4 count to define treatment failure. Receives: Other: Viral Load |
| Clinical, Immunologic and Virologic criteria | Active comparator | In the Clinical, Immunologic and Virologic criteria was based on a confirmed viral load of > 1000 HIV RNA copies/ml; as well as clinical and immunologic criteria Receives: Other: Viral Load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Criteria for switching HIV-Infected Children to second line
Confirmed viral load > 1,000 HIV RNA copies/ml
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 May 2013
- Primary completion16 Jan 2017
- Study completion16 Jan 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- MU-JHU CARE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489953
- Sponsor's protocol ID
- 9415
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kibalama Ssemambo P, Nalubega-Mboowa MG, Owora A, Serunjogi R, Kironde S, Nakabuye S, Ssozi F, Nannyonga M, Musoke P, Barlow-Mosha L. Virologic response of treatment experienced HIV-infected Ugandan children and adolescents on NNRTI based first-line regimen, previously monitored without viral load. BMC Pediatr. 2021 Mar 22;21(1):139. doi: 10.1186/s12887-021-02608-0.
PubMed 33752636
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children
- ClinicalTrials.gov ID
- NCT04489953
- Acronym / sponsor ID
- 9415
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- MU-JHU CAREUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 16 Jan 2017 (actual)
- Study completion
- 16 Jan 2017 (actual)
- First posted
- 28 Jul 2020 (actual)
- 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.
The main goal was to compare clinical and immunological versus clinical, immunological plus viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes, including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses for treatment experienced children randomized to two switching criteria.
Detailed description
The overall goal of the study was aimed at determining whether the use of the current WHO criteria alone (clinical and immunologic) to define treatment failure as the trigger for switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month treatment outcomes when compared to combining clinical and immunologic parameters with viral load (VL) monitoring.
In addition the study aimed at obtaining plasma samples from treatment experienced children, for future resistance testing. The results of this study may help guide WHO and national pediatric ART programs on the need for routine VL monitoring for children initiating HAART in resource limited settings, where virologic tests including resistance testing are not readily available or affordable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical and Immunologic criteria | Active comparator | Other: Viral LoadIn the clinical and immunologic monitoring criteria was based on the 2010 WHO guidelines. Whereby children were monitored using clinical presentation and CD4 count to define treatment failure. |
| Clinical, Immunologic and Virologic criteria | Active comparator | Other: Viral LoadIn the Clinical, Immunologic and Virologic criteria was based on a confirmed viral load of > 1000 HIV RNA copies/ml; as well as clinical and immunologic criteria |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- HIV-Infected Children, 1 year to 12 years
- ART experienced and enrolled in an existing treatment program that used clinical and immunologic criteria to monitor response to ART.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Viral LoadFor the Clinical and Immunologic criteria, viral load was done retrospectively on stored plasma samples. Whereas for the Clinical, Immunologic and Virologic criteria, viral load was done in real-time | Other | Clinical and Immunologic criteria, Clinical, Immunologic and Virologic criteria |
Primary outcome
Criteria for switching HIV-Infected Children to second line
Time frame: 2 years
Confirmed viral load > 1,000 HIV RNA copies/ml
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 28 Jul 2020.
- Derived from this study: PubMed 33752636Kibalama Ssemambo P, Nalubega-Mboowa MG, Owora A, Serunjogi R, Kironde S, Nakabuye S, Ssozi F, Nannyonga M, Musoke P, Barlow-Mosha L. Virologic response of treatment experienced HIV-infected Ugandan children and adolescents on NNRTI based first-line regimen, previously monitored without viral load. BMC Pediatr. 2021 Mar 22;21(1):139. doi: 10.1186/s12887-021-02608-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Viral Load in people with HIV, run by MU-JHU CARE.
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 2 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Criteria for switching HIV-Infected Children to second line (time frame: 2 years). 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 NCT04489953, 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 28 Jul 2020.