Trial · NCT02028676
Registered outcomes58
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 58
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death | Median 4 years (from randomization to 16 March 2012; maximum 5 years) | Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods |
| Primary | LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV | Median 4 years (from randomization to 16 March 2012; maximum 5 years) | Number of participants with a new Grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods |
| Primary | Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation | Baseline, 72 weeks | |
| Primary | Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation | Baseline, 144 weeks | |
| Primary | Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV | Median 4 years (from randomization to 16 March 2012; maximum 5 years) | Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods |
| Primary | Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation | 48 weeks | Number of participants with HIV RNA viral load \<80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of \<80 copies/ml was used to indicate suppression. |
| Primary | Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir | Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years) | Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, judged definitely/probably or uncertain whether related to lamivudine or abacavir, to be analysed using time-to-event methods |
| Primary | Cotrimoxazole: New Hospitalisation or Death | Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years) | Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods |
| Primary | Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV | Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years) | Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods |
| Secondary | LCM vs CDM, Induction ART: All-cause Mortality | Median 4 years (from randomization to 16 March 2012; maximum 5 years) | Number of participants who died from any cause, to be analysed using time-to-event methods |
| Secondary | Induction ART: New WHO Stage 4 Event or Death | Median 4 years (from randomization to 16 March 2012; maximum 5 years) | Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods |
| Secondary | LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death | Median 4 years (from randomization to 16 March 2012; maximum 5 years) | Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods |
| Secondary | LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death | Median 4 years (from randomization to 16 March 2012; maximum 5 years) | Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods |
| Secondary | LCM vs CDM, Induction ART: Weight-for-age Z-score | Baseline and a median of 4 years (maximum 5 years) | Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). |
| Secondary | LCM vs CDM, Induction ART: Height-for-age Z-score | Baseline and a median of 4 years (maximum 5 years) | Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). |
| Secondary | LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score | Baseline and a median of 4 years (maximum 5 years) | Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). |
| Secondary | LCM vs CDM: Change From Baseline in CD4% to Week 72 | Baseline, week 72 | |
| Secondary | LCM vs CDM: Change From Baseline in CD4% to Week 144 | Baseline, week 144 | |
| Secondary | LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72 | Baseline, week 72 | Estimated in those \>5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) |
| Secondary | LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144 | Baseline, week 144 | Estimated in those \>5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) |
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.
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