Comparison · NCT00625404-af42fdec
Truvada Arm vs Placebo Arm: FTC and/or Tenofovir Resistance
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. Truvada Arm vs Placebo Arm: FTC and/or Tenofovir Resistance. Trial comparisons, record NCT00625404-af42fdec. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00625404-af42fdec
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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 | 0.0909 | 0.0314 | 0.236 | wilson | |
| Risk in group 2 | 0.0286 | 0.00506 | 0.145 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0623 | -0.0687 | 0.209 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.18 | 0.348 | 29.1 | log | |
| Odds ratio, group 1 over group 2 | 3.4 | 0.336 | 34.5 | log | |
| Number needed to treat, for one more participant with the outcome on Truvada Arm than on Placebo Arm | 16 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Truvada Arm | Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg). | 3 | 33 | OG000 |
| Group 2 | Placebo Arm | Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients. | 1 | 35 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- FTC and/or Tenofovir Resistance
- Description
Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).~participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time.
- Time frame
- up to 52 weeks
- Population
- All women who seroconverted were assessed for possible resistance.
Source ClinicalTrials.gov
Trial
- Title
- FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
- NCT number
- NCT00625404
- Phases
- PHASE3
- Conditions
- HIV Infections
- Interventions
- Truvada, Placebo
- Lead sponsor
- FHI 360
- Results first posted
- 2014-04-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00625404?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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