Comparison · NCT00074581-sae
Early-ART vs Delayed-ART: 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. Early-ART vs Delayed-ART: serious adverse events. Trial comparisons, record NCT00074581-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00074581-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 | 0.594 | 0.561 | 0.626 | wilson | |
| Risk in group 2 | 0.595 | 0.562 | 0.627 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00153 | -0.0473 | 0.0442 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.997 | 0.923 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.994 | 0.822 | 1.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Early-ART than on Delayed-ART | 653 | 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 | Early-ART | Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided. | 526 | 886 | EG000 |
| Group 2 | Delayed-ART | Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible. | 522 | 877 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Preventing Sexual Transmission of HIV With Anti-HIV Drugs
- NCT number
- NCT00074581
- Phases
- PHASE3
- Conditions
- HIV Infections
- Interventions
- Atazanavir, Didanosine, Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate, Lamivudine, Lopinavir/Ritonavir, Nevirapine, Stavudine, Tenofovir disoproxil fumarate, Zidovudine/Lamivudine
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2016-10-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00074581?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT00074581-sae