Comparison · NCT01617096-e1de421b
Dapivirine Vaginal Ring vs Placebo Ring: Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection.
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. Dapivirine Vaginal Ring vs Placebo Ring: Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection. Trial comparisons, record NCT01617096-e1de421b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01617096-e1de421b
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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 | 0.958 | 0.883 | 0.986 | wilson | |
| Risk in group 2 | 0.99 | 0.944 | 0.998 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0319 | -0.107 | 0.0216 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.968 | 0.918 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.236 | 0.024 | 2.32 | log | |
| Number needed to treat, for one fewer participant with the outcome on Dapivirine Vaginal Ring than on Placebo Ring | 31.3 | 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 | Dapivirine Vaginal Ring | Vaginal ring containing 25mg dapivirine~Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months | 68 | 71 | OG000 |
| Group 2 | Placebo Ring | Vaginal ring containing no drug substance~Placebo Ring: Vaginal ring containing no drug substance | 96 | 97 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection.
- Description
The analysis of HIV-1 drug resistance will be primarily descriptive in nature, and will depend on the pattern of resistance mutations observed in the HIV-1 seroconverters. The percentage of HIV-1 seroconverters with at least one HIV-1 drug resistant mutation will be presented overall, and by treatment arm, with corresponding 95% CIs.
- Time frame
- minimum of 12 months and a maximum of 14 months per participant
- Population
The virology population included all ITT participants with seroconversion, excluding those who never received investigational product, or were retrospectively found to be HIV-1 RNA positive at enrollment (m-ITT) or were HIV-1 infected after discontinuation of ring use. Seroconversions among participants who were continued on open-label DVR-004 were included in the DVR-004 group, independent of initial randomization.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
- NCT number
- NCT01617096
- Phases
- PHASE3
- Conditions
- HIV Infections
- Interventions
- Dapivirine Vaginal Ring, Placebo Ring
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Results first posted
- 2022-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01617096?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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