Comparison · NCT00458393-6f3cbbb0
TDF/FTC vs Placebo: Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis
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. TDF/FTC vs Placebo: Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis. Trial comparisons, record NCT00458393-6f3cbbb0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00458393-6f3cbbb0
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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 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.39 | 0.39 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | TDF/FTC | Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | 0 | 6 | OG000 |
| Group 2 | Placebo | Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate | 0 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis
- Description
A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to \>5 fold upper limit of normal at any visit, or an increase to \>2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug.~More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/
- Time frame
- Quarterly lab tests through a median follow-up of 1.2 years
- Population
- Those with chronic active hepatitis B at enrollment.
Source ClinicalTrials.gov
Trial
- Title
- Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
- NCT number
- NCT00458393
- Phases
- PHASE3
- Conditions
- HIV Infections
- Interventions
- daily TDF/FTC, Placebo
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2018-01-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00458393?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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