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Comparison · NCT02028676-5ef437da

Once-daily ABC+3TC vs Twice-daily ABC+3TC: Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Once-daily ABC+3TC vs Twice-daily ABC+3TC: Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV. Trial comparisons, record NCT02028676-5ef437da. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02028676-5ef437da

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.170.1330.213wilson
Risk in group 20.1620.1260.206wilson
Risk difference, group 1 minus group 20.00748-0.04910.064newcombe hybrid score
Risk ratio, group 1 over group 21.050.7451.47log
Odds ratio, group 1 over group 21.060.7021.59log
Number needed to treat, for one more participant with the outcome on Once-daily ABC+3TC than on Twice-daily ABC+3TC134from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Once-daily ABC+3TCOther Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa57336OG000
Group 2Twice-daily ABC+3TCOther Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa54333OG001

Outcome

Type
SECONDARY
Title
Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
Description
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
Time frame
Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)
Population

Source ClinicalTrials.gov

Trial

Title
Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
NCT number
NCT02028676
Phases
PHASE4
Conditions
Human Immunodeficiency Virus
Interventions
Clinically Driven Monitoring (CDM), Laboratory plus Clinical Monitoring (LCM), Arm A: ABC+3TC+NNRTI, Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance, Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance, Once-daily ABC+3TC, Twice-daily ABC+3TC, Continued cotrimoxazole prophylaxis, Stopped cotrimoxazole prophylaxis
Lead sponsor
Medical Research Council
Results first posted
2014-06-06

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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