Comparison · NCT00608569-sae
mDOT Arm vs Non-mDOT Arm: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. mDOT Arm vs Non-mDOT Arm: serious adverse events. Trial comparisons, record NCT00608569-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00608569-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0465 | 0.0215 | 0.0978 | wilson | |
| Risk in group 2 | 0.0547 | 0.0267 | 0.109 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00818 | -0.0676 | 0.0502 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.85 | 0.294 | 2.46 | log | |
| Odds ratio, group 1 over group 2 | 0.843 | 0.275 | 2.58 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on mDOT Arm than on Non-mDOT Arm | 122 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | mDOT Arm | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks. | 6 | 129 | EG000 |
| Group 2 | Non-mDOT Arm | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks. | 7 | 128 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 52 weeks since randomization
Source ClinicalTrials.gov
Trial
- Title
- Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults
- NCT number
- NCT00608569
- Phases
- NA
- Conditions
- HIV Infections
- Interventions
- Lopinavir/ritonavir, Emtricitabine/Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate, Zidovudine, Emtricitabine
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Results first posted
- 2013-11-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00608569?tab=results
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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