Comparison · NCT00625404-3c30052b
Truvada Arm vs Placebo Arm: Confirmed Grade 2 or Higher Serum Creatinine Toxicity
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: Confirmed Grade 2 or Higher Serum Creatinine Toxicity. Trial comparisons, record NCT00625404-3c30052b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00625404-3c30052b
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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 | 0.00392 | 0.00152 | 0.01 | wilson | |
| Risk in group 2 | 0.00194 | 0.000531 | 0.00703 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00198 | -0.00365 | 0.00825 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.02 | 0.371 | 11 | log | |
| Odds ratio, group 1 over group 2 | 2.03 | 0.371 | 11.1 | log | |
| Number needed to treat, for one more participant with the outcome on Truvada Arm than on Placebo Arm | 505 | 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). | 4 | 1,021 | 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. | 2 | 1,033 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Confirmed Grade 2 or Higher Serum Creatinine Toxicity
- Description
- Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal
- Time frame
- cumulative toxicity through 52 weeks of product use and 4 weeks post product
- Population
The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.
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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