Comparison · NCT00978068-sae
Group 1 vs Group 2: 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. Group 1 vs Group 2: serious adverse events. Trial comparisons, record NCT00978068-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00978068-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 | 0.131 | 0.0747 | 0.219 | wilson | |
| Risk in group 2 | 0.105 | 0.056 | 0.187 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0263 | -0.0735 | 0.127 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.547 | 2.86 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.505 | 3.29 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group 1 than on Group 2 | 38 | 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 | Group 1 | LPV/r + 2 NRTIs~LPV/r + 2 NRTIs: Group 1~Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)~The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons. | 11 | 84 | EG000 |
| Group 2 | Group 2 | NVP or EFV + 2 NRTIs~NVP or EFV + 2 NRTIs: Group 2~Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI~NVP will be used for children \< 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be stavudine. | 9 | 86 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Time from randomization to at least 24 months of follow up or until end of the study
Source ClinicalTrials.gov
Trial
- Title
- HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
- NCT number
- NCT00978068
- Phases
- PHASE3
- Conditions
- Malaria, HIV Infections
- Interventions
- Lopinavir/Ritonavir (LPV/r), Nevirapine (NVP), Efavirenz (EFV), 2 nucleoside reverse transcriptase inhibitor (NRTI)
- Lead sponsor
- University of California, San Francisco
- Results first posted
- 2018-12-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00978068?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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GET https://conductscience.org/api/comparisons/v1/NCT00978068-sae