Trial · NCT02259127
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Proportion With Failure (Clinical or Virological) | 96 weeks post randomisation | Treatment failure by 96 weeks. Estimated using time to the first occurrence of any of the following components: * Insufficient virological response defined as \< 1 log10 drop at week 24 and switch to second/third line ART for treatment failure * Viral Load (VL)\>400 c/ml at or after 36 weeks confirmed by next visit * Death due to any cause * Any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events, adjudicated by the Endpoint Review Committee |
| Secondary | HIV-1 RNA <50c/ml at 96 Weeks | 96 weeks post randomisation | Proportion of children with viral load suppression \<50 c/ml at 96 weeks. |
| Secondary | HIV-1 RNA <400c/mL at 96 Weeks | 96 weeks post randomisation | Proportion of children with viral load suppression \<400 c/ml at 96 weeks |
| Secondary | Mean Change in CD4 Count From Baseline to Week 96 | 96 weeks post randomisation | Reporting mean change from the global baseline value across both arms. |
| Secondary | Mean Change in Total Cholesterol From Baseline to Week 96 | 96 weeks post randomisation | Reporting mean change from global baseline value across both arms. |
| Secondary | Serious Adverse Events | Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). | Incidence of serious adverse events |
| Secondary | Grade 3 or Above Clinical and Laboratory Adverse Events | Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). | Incidence of new clinical and laboratory grade 3 and 4 adverse events |
| Secondary | Adverse Events Leading to ART Modification Any Grade | Randomised Phase | Incidence of adverse events (of any grade) leading to treatment modification |
| Secondary | Treatment Failure by 48 Weeks | 48 weeks post randomisation | Treatment failure by 48 weeks. Difference in proportion with clinical or virological failure (as defined above) |
| Secondary | Treatment Failure by 144 Weeks | 144 weeks post randomisation | Treatment failure by 144 weeks. Difference in proportion with clinical or virological failure (as defined above) |
| Secondary | WHO 4, Severe WHO 3 Events and Death | Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort). | Rate of clinical events : WHO 4, severe WHO 3 events and death |
| Secondary | Per Protocol: Treatment Failure by 96 Weeks | 96 weeks post randomisation | Per protocol: treatment failure by 96 weeks post randomisation |
| Secondary | Any Drug Class Resistance After Virologic Failure | 96 weeks post randomisation | Any drug class resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. |
| Secondary | NRTI Resistance After Virologic Failure | 96 weeks post randomisation | NRTI resistance after virologic failure 96 weeks post randomisation. Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. |
| Secondary | NNRTI Resistance After Virologic Failure | 96 weeks post randomisation | NNRTI resistance after virologic failure 96 weeks post randomisation. Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. |
| Secondary | PI Resistance After Virologic Failure | 96 weeks post randomisation | PI resistance after virologic failure 96 weeks post randomisation. Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. |
| Secondary | INSTI Resistance After Virologic Failure | 96 weeks post randomisation | INSTI resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. |
| Secondary | Emerging Resistance to Any Drug Class After Virologic Failure | 96 weeks post randomisation | Emerging resistance to any drug class after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. \>=14kg cohort: among participants with virologic failure and exposure to the drug class, percentage of participants with emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without. \<14kg cohort: percentage reported for participants with whom resistance test was available post-failure and at baseline, and exposed to drug-class during trial. |
| Secondary | NRTI Emerging Resistance After Virologic Failure | 96 weeks post randomisation | NRTI emerging resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. \>=14kg cohort: among participants with virologic failure and exposure to the drug class, percentage of participants with emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without. \<14kg cohort: percentage reported for participants with whom a resistance test was available post-failure and at baseline, and exposed to drug-class during trial. |
| Secondary | NNRTI Emerging Resistance After Virologic Failure | 96 weeks post randomisation | NNRTI emerging resistance after virologic failure 96 weeks post randomisation Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. \>=14kg cohort: among participants with virologic failure and exposure to the drug class, percentage of participants with emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without. \<14kg cohort: percentage reported for participants with whom a resistance test was available post-failure and at baseline, and exposed to drug-class during trial. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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