Comparison · NCT00105079-sae
Saquinavir/Ritonavir vs Lopinavir/Ritonavir: serious adverse events
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. Saquinavir/Ritonavir vs Lopinavir/Ritonavir: serious adverse events. Trial comparisons, record NCT00105079-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00105079-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 | 0.147 | 0.101 | 0.21 | wilson | |
| Risk in group 2 | 0.113 | 0.0736 | 0.17 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0341 | -0.0391 | 0.108 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 0.742 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 1.35 | 0.711 | 2.58 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Saquinavir/Ritonavir than on Lopinavir/Ritonavir | 29.3 | 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 | Saquinavir/Ritonavir | saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. | 24 | 163 | EG000 |
| Group 2 | Lopinavir/Ritonavir | lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. | 19 | 168 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All new nonserious AEs and SAEs, irrespective of causal relationship, were reported up to 28 days after the last dose of study treatment. Serious AEs considered related to the test drug were to be reported indefinitely. (Up to 52 weeks)
Source ClinicalTrials.gov
Trial
- Title
- GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
- NCT number
- NCT00105079
- Phases
- PHASE3
- Conditions
- HIV Infections
- Interventions
- saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate, Ritonavir
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2011-11-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00105079?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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