Trial · NCT01539226
Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
NCT01539226, Not applicable, Completed, International Partnership for Microbicides, Inc.; results first posted 2022-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women. Trials, record NCT01539226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01539226
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
- NCT number
- NCT01539226
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,959 participants, actual
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Conditions
- HIV Infections
- Interventions
- Placebo Vaginal Ring, Dapivirine Vaginal Ring, 25 mg
- First posted
- 2012-02-27
- Last updated
- 2022-10-19
- Results first posted
- 2022-10-19
- 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 outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. | 24 months | HIV-1 seroconversion measured by rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm. |
| Primary | All Adverse Events | 24 months | Self-reports, physical examination, gynaecological assessments, including pelvic/speculum examination, laboratory tests and other indicated investigations. All AEs will be reported, regardless of grade or relatedness. |
| Secondary | The Incidence Rate of HIV-2 Seroconversion. | 24 months | Rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm in Appendix C of protocol. |
| Secondary | The Incidence of Curable STIs | 24 months | The percentage of participants testing positive for any STI (gonorrhoea, chlamydia, trichomonas, syphilis) will be assessed. |
| Secondary | Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period; | 24 months | The percentage of participants with pregnancies in each treatment group. For each treatment group, the numerator will include the number of participants that had a positive urine pregnancy test during the trial period. |
| Secondary | The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period; | 24 months | Questionnaires and qualitative data regarding sexual behaviour and adherence to the use of a vaginal ring inserted once every 4 weeks over the trial period. Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use, |
| Secondary | The Percentage of Women Who Report the Use of the Vaginal Ring as Acceptable; | 24 months | Questionnaires and qualitative data regarding the acceptability of use of a vaginal ring inserted once every 4 weeks over the trial period; Number 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 | The Percentage of Participants With HIV-1 Drug Resistance Mutations Among Participants Who Acquire HIV-1. | 24 months | 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 proportion 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
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. | 24 months | This population consisted of all participants included in the ITT population (all randomised), excluding those who were not identified as HIV-seropositive at the Enrollment Visit, but who were later found to be already HIV-1 infected at enrollment through HIV-1 RNA PCR testing. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All Adverse Events | 24 months | The safety population included all participants who had been randomized to IP and used at least one DVR or placebo ring. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence Rate of HIV-2 Seroconversion. | 24 months | This population consisted of all participants included in the ITT population, excluding those who were not identified as HIV-seropositive at the Enrollment Visit, but who were later found to be already HIV-1 infected at enrollment through HIV-1 RNA PCR testing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence of Curable STIs | 24 months | The safety population included all participants who had been randomized to IP and used at least one DVR or placebo ring. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period; | 24 months | The safety population included all participants who had been randomized to IP and used at least one DVR or placebo ring. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period; | 24 months | 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. | percentage of participants with data | NUMBER |
| SECONDARY | The Percentage of Women Who Report the Use of the Vaginal Ring as Acceptable; | 24 months | This population consisted of all participants included in the ITT population, excluding those who were not identified as HIV-seropositive at the Enrollment Visit, but who were later found to be already HIV-1 infected at enrollment through HIV-1 RNA PCR testing. | percentage of participants with data | NUMBER |
| SECONDARY | The Percentage of Participants With HIV-1 Drug Resistance Mutations Among Participants Who Acquire HIV-1. | 24 months | 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 |
|---|---|---|---|---|---|
| HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. | Dapivirine Vaginal Ring | 82 | Participants | ||
| HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. | Placebo Vaginal Ring | 61 | Participants | ||
| All Adverse Events | Dapivirine Vaginal Ring | 1147 | Participants | ||
| All Adverse Events | Placebo Vaginal Ring | 561 | Participants | ||
| The Incidence Rate of HIV-2 Seroconversion. | Dapivirine Vaginal Ring | 0 | Participants | ||
| The Incidence Rate of HIV-2 Seroconversion. | Placebo Vaginal Ring | 0 | Participants | ||
| The Incidence of Curable STIs | Dapivirine Vaginal Ring | 682 | Participants | ||
| The Incidence of Curable STIs | Placebo Vaginal Ring | 315 | Participants | ||
| Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period; | Dapivirine Vaginal Ring | 43 | Participants | ||
| Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period; | Placebo Vaginal Ring | 20 | Participants |
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 | Placebo Vaginal Ring | 652 | |
| Overall Study | STARTED | Dapivirine Vaginal Ring | 1,307 | |
| Overall Study | COMPLETED | Placebo Vaginal Ring | 435 | |
| Overall Study | COMPLETED | Dapivirine Vaginal Ring | 902 | |
| Overall Study | NOT COMPLETED | Placebo Vaginal Ring | 217 | |
| Overall Study | NOT COMPLETED | Dapivirine Vaginal Ring | 405 |
Source ClinicalTrials.gov
Adverse events168
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 | Gynaecological chlamydia infection | Infections and infestations | Placebo Vaginal Ring | 213 | 652 | 328 |
| other | Gynaecological chlamydia infection | Infections and infestations | Dapivirine Vaginal Ring | 427 | 1,306 | 669 |
| other | Genital infection female | Infections and infestations | Placebo Vaginal Ring | 126 | 652 | 166 |
| other | Genital infection female | Infections and infestations | Dapivirine Vaginal Ring | 300 | 1,306 | 388 |
| other | Genitourinary tract gonococcal infection | Infections and infestations | Placebo Vaginal Ring | 108 | 652 | 146 |
| other | Genitourinary tract gonococcal infection | Infections and infestations | Dapivirine Vaginal Ring | 252 | 1,306 | 333 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Vaginal Ring | 115 | 652 | 247 |
| other | Upper respiratory tract infection | Infections and infestations | Dapivirine Vaginal Ring | 231 | 1,306 | 536 |
| other | Trichomoniasis | Infections and infestations | Placebo Vaginal Ring | 103 | 652 | 150 |
| other | Trichomoniasis | Infections and infestations | Dapivirine Vaginal Ring | 225 | 1,306 | 351 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Vaginal Ring | 3 | 652 |
| Total, all-cause mortality | Dapivirine Vaginal Ring | 2 | 1,306 |
| Total, other adverse events | Placebo Vaginal Ring | 561 | 652 |
| Total, other adverse events | Dapivirine Vaginal Ring | 1,147 | 1,306 |
| Total, serious adverse events | Placebo Vaginal Ring | 9 | 652 |
| Total, serious adverse events | Dapivirine Vaginal Ring | 41 | 1,306 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dapivirine Vaginal Ring vs Placebo Vaginal Ring: Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period; | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Vaginal Ring: The Incidence Rate of HIV-2 Seroconversion. | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Vaginal Ring: The Percentage of Participants With HIV-1 Drug Resistance Mutations Among Participants Who Acquire HIV-1. | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Vaginal Ring: All Adverse Events | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Vaginal Ring: HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Vaginal Ring: The Incidence of Curable STIs | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Vaginal Ring: deaths from any cause | Trial comparisons |
| Dapivirine Vaginal Ring vs Placebo Vaginal 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01539226
GET https://conductscience.org/api/trials/v1/NCT01539226/results?page=2