Trial · NCT01617096
Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
NCT01617096, Phase 3, Completed, International Partnership for Microbicides, Inc.; results first posted 2022-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women. Trials, record NCT01617096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01617096
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
- NCT number
- NCT01617096
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,629 participants, actual
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Conditions
- HIV Infections
- Interventions
- Dapivirine Vaginal Ring, Placebo Ring
- First posted
- 2012-06-12
- Last updated
- 2022-12-21
- Results first posted
- 2022-12-16
- Limitations and caveats
Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use; however, they were found to be an imperfect measure of adherence as they cannot distinguish different patterns of use during the month. In addition, self-reported adherence based on the adherence questionnaires was also considered to have limitations.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. | minimum of 12 months and a maximum of 14 months per participant | The primary endpoint is HIV-1 seroconversion as measured by rapid and specialised laboratory testing according to comprehensive HIV testing algorithm. Endpoint confirmation of HIV infection is by Western Blot. |
| Primary | The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). | minimum of 12 months and a maximum of 14 months per participant | Participants with grade 2 adverse events, judged to be related to investigational product, grade 3 and grade 4 adverse events and all serious adverse events. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death |
| Secondary | Adherence to the Dapivirine Vaginal Ring. | 12 months per participant | Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use. Adherence was defined as a dapivirine ring residual level \<=23.5 mg and dapivirine plasma level \>= 95 pg/mL. |
| Secondary | Acceptability of the DVR and Placebo Vaginal Ring | 12 months per participant | Questionnaires and qualitative data regarding the acceptability of use of a vaginal ring inserted once every 4 weeks over the trial period; Percentage of participants with positive response. Response of 'likely' or 'very likely' to the question: 'If in the future a vaginal ring was available that provided some protection against HIV, and it was similar to the one you used in this trial, how likely would you be to keep it inserted in your vagina every day?' |
| Secondary | Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection. | minimum of 12 months and a maximum of 14 months per participant | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. | minimum of 12 months and a maximum of 14 months per participant | The primary effectiveness Cohort included all eligible randomised participants excluding participants deemed to be HIV-1 RNA positive at the time of randomization, based on retrospective PCR testing of stored blood samples taken at enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). | minimum of 12 months and a maximum of 14 months per participant | The Primary Safety Cohort (or ITT Cohort) included all eligible, randomized participants. All participants were analyzed as members of the treatment group to which they were randomized regardless of adherence to the planned course of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adherence to the Dapivirine Vaginal Ring. | 12 months per participant | Adherence is defined by a dapivirine residual level in returned used rings ≤ 23.5 mg and a dapivirine plasma concentration ≥ 95 pg/mL (if they are both available; otherwise categorisation was based on the available measurement. The objective measures (dapivirine residual levels in used rings and dapivirine plasma concentrations) used can only be determined for participants who used the active vaginal dapivirine ring. | participants with data | NUMBER |
| SECONDARY | Acceptability of the DVR and Placebo Vaginal Ring | 12 months per participant | The Primary Safety Cohort (or ITT Cohort) included all eligible, randomized participants. Acceptability was reported for participant who provided responses to acceptability questionnaires. | percentage of participants with data | NUMBER |
| SECONDARY | Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection. | minimum of 12 months and a maximum of 14 months per participant | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. | Dapivirine Vaginal Ring | 71 | Participants | ||
| Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. | Placebo Ring | 97 | Participants | ||
The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). | Dapivirine Vaginal Ring | 1237 | Participants | ||
The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). | Placebo Ring | 1231 | Participants | ||
| Adherence to the Dapivirine Vaginal Ring. | Dapivirine Vaginal Ring | Month 1 | 443 | participants with data | |
| Adherence to the Dapivirine Vaginal Ring. | Dapivirine Vaginal Ring | Month 2 | 460 | participants with data | |
| Adherence to the Dapivirine Vaginal Ring. | Dapivirine Vaginal Ring | Month 3 | 953 | participants with data | |
| Adherence to the Dapivirine Vaginal Ring. | Dapivirine Vaginal Ring | Month 4 | 537 | participants with data | |
| Adherence to the Dapivirine Vaginal Ring. | Dapivirine Vaginal Ring | Month 5 | 573 | participants with data | |
| Adherence to the Dapivirine Vaginal Ring. | Dapivirine Vaginal Ring | Month 6 | 963 | participants with data |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapivirine Vaginal Ring | 1,313 | |
| Overall Study | STARTED | Placebo Ring | 1,316 | |
| Overall Study | COMPLETED | Dapivirine Vaginal Ring | 1,165 | |
| Overall Study | COMPLETED | Placebo Ring | 1,179 | |
| Overall Study | NOT COMPLETED | Dapivirine Vaginal Ring | 148 | |
| Overall Study | NOT COMPLETED | Placebo Ring | 137 |
Source ClinicalTrials.gov
Adverse events178
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Metrorrhagia | Reproductive system and breast disorders | Dapivirine Vaginal Ring | 723 | 1,313 | |
| other | Metrorrhagia | Reproductive system and breast disorders | Placebo Ring | 732 | 1,316 | |
| other | Menorrhagia | Reproductive system and breast disorders | Dapivirine Vaginal Ring | 259 | 1,313 | |
| other | Menorrhagia | Reproductive system and breast disorders | Placebo Ring | 242 | 1,316 | |
| other | Vaginal discharge | Reproductive system and breast disorders | Dapivirine Vaginal Ring | 179 | 1,313 | |
| other | Vaginal discharge | Reproductive system and breast disorders | Placebo Ring | 174 | 1,316 | |
| other | Menometrorrhagia | Reproductive system and breast disorders | Dapivirine Vaginal Ring | 160 | 1,313 | |
| other | Menometrorrhagia | Reproductive system and breast disorders | Placebo Ring | 148 | 1,316 | |
| other | Vulvovaginal pruritus | Reproductive system and breast disorders | Dapivirine Vaginal Ring | 128 | 1,313 | |
| other | Vulvovaginal pruritus | Reproductive system and breast disorders | Placebo Ring | 135 | 1,316 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapivirine Vaginal Ring | 4 | 1,313 |
| Total, all-cause mortality | Placebo Ring | 3 | 1,316 |
| Total, other adverse events | Dapivirine Vaginal Ring | 1,237 | 1,313 |
| Total, other adverse events | Placebo Ring | 1,041 | 1,316 |
| Total, serious adverse events | Dapivirine Vaginal Ring | 116 | 1,313 |
| Total, serious adverse events | Placebo Ring | 130 | 1,316 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1AI068633 | Leadership and Operations Center (LOC): Microbicide Trials Network | HILLIER, SHARON L. | MAGEE-WOMEN'S RES INST AND FOUNDATION | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2011 to 2021 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dapivirine Vaginal Ring vs Placebo Ring: Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Ring: deaths from any cause | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Ring: Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection. | Trial comparisons |
Dapivirine Vaginal Ring vs Placebo Ring: The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Ring: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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