Comparison · NCT02269917-7a771dcd
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) vs Control (Baseline to Switch): Number of Participants With Resistance to Study Drug
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. D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) vs Control (Baseline to Switch): Number of Participants With Resistance to Study Drug. Trial comparisons, record NCT02269917-7a771dcd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02269917-7a771dcd
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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 | 0.0526 | 0.00935 | 0.246 | wilson | |
| Risk in group 2 | 0.375 | 0.137 | 0.694 | wilson | |
| Risk difference, group 1 minus group 2 | -0.322 | -0.645 | -0.0154 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.14 | 0.0171 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.0926 | 0.00783 | 1.1 | log | |
| Number needed to treat, for one fewer participant with the outcome on D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) than on Control (Baseline to Switch) | 3.1 | 1.55 | 65.1 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension). | 1 | 19 | OG000 |
| Group 2 | Control (Baseline to Switch) | Participants received a boosted protease inhibitor (bPI) (limited to darunavir \[DRV\] or atazanavir with low-dose ritonavir \[rtv\] or cobicistat \[COBI\], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48. | 3 | 8 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Resistance to Study Drug
- Description
HIV-1 genotypes were analyzed from samples of participants with confirmed virologic rebound (virologic rebound was defined as: confirmed HIV-1 RNA \>=50 copies/mL up to, and including the upper bound of the Week 48 window) and with HIV-1 RNA value \>=400 copies/mL or who discontinued with last HIV-1 RNA \>=400 copies/mL. Number of participants who developed resistance to any of the study drug was determined.
- Time frame
- Up to Week 48
- Population
- The ITT population with confirmed virologic rebound and with HIV-1 RNA value \>=400 copies/mL was analyzed.
Source ClinicalTrials.gov
Trial
- Title
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
- NCT number
- NCT02269917
- Phases
- PHASE3
- Conditions
- Human Immunodeficiency Virus Type 1
- Interventions
- D/C/F/TAF, Boosted Protease Inhibitor (bPI), FTC/TDF
- Lead sponsor
- Janssen R&D Ireland
- Results first posted
- 2018-11-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02269917?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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