A Phase 3 interventional study of Dapivirine Vaginal Ring-004 in HIV Prevention, sponsored by International Partnership for Microbicides, Inc.. Completed at 6 sites in 2 countries. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by International Partnership for Microbicides, Inc. (part of Population Council) · Phase 3, Interventional, and Prevention
A follow-on, open label trial to assess continued safety of and adherence to the Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women
Phase IIIb, multicenter follow-on open-label trial to evaluate the continued adherence to and safety of the DVR, inserted at monthly intervals by healthy, HIV negative women who had participated in the IPM 027 Phase III DVR trial. All women who participated in IPM 027 (NCT 01539226) and were HIV-negative at screening for IPM 032, were eligible.
Participants who provided written informed consent at screening were invited to undergo screening assessments for the trial. The Enrollment Visit had to occur within 45 days after the Screening Visit. Note: In the event that participation in IPM 027 was stopped prematurely and IPM 032 was activated at the RC, the IPM 027 Last Product Use Visit (LPUV) and the IPM 032 Screening and Enrollment Visits could be combined for participants who were eligible to enroll in IPM 032.
All participants received the DVR containing 25 mg dapivirine at the Enrollment Visit, and attended a visit at the RC, 1 month after enrollment. Following this visit, a participant could continue on a 3 monthly visit schedule, at the Investigator's discretion. Monthly visits could, however, be extended up to the first 3 months of participation. From then on, all participants needed to switch to a 3-monthly schedule. Once the 3-monthly trial visit schedule commenced, three rings were dispensed at each visit. One ring was self-inserted at the RC and two additional rings were dispensed for the participant to take home, or dispensing took place as arranged with the participant.
The protocol made provision for at least 12 months of DVR use (with the LPUV scheduled at Month 12), which could also have been extended. Participants could continue with ring use past Month 12 and the RCs could continue scheduling the 3-monthly visits as per the participant visit schedule. Exit Visits of participants who completed 12 months or more on the trial commenced in October 2017 and ended in January 2019. Participants who were still enrolled in the trial in October 2017 and those who had been enrolled at a later stage in the trial were scheduled to attend the Month 12 Visit, irrespective of their visit schedule assignments. Exit Visits were then scheduled as per protocol, ie, 1 to 2 months after the Month 12 Visit. Exit Visits were optional for participants who discontinued early from the trial.
Adherence assessments included analysis of dapivirine residual levels in returned used rings, correlation analysis of dapivirine residual levels with visual inspection of used rings, and self-reported acceptability and adherence.
The HIV-1 incidence and the occurrence of HIV-1 drug resistance were assessed using HIV rapid testing and genotyping, respectively.
Social and behavioral parameters were assessed qualitatively and quantitatively. Quantitative assessments included evaluation of the feasibility of 3-monthly follow-up visits and evaluation of the proportion of participants undergoing unscheduled HIV rapid tests (ie, in between the scheduled 3 monthly follow-up visits).
Safety assessments included adverse event (AE) reporting, safety laboratory assessments, pregnancy testing, physical examination, vital sign assessments, pelvic examination, sexually transmitted infection (STI) tests, cervical cytology, and assessments of social harms.
Throughout the trial, all participants received pre- and post-test HIV counseling, HIV/STI risk reduction counseling, and contraceptive, condom and vaginal ring adherence counseling.
International Partnership for Microbicides, Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 5 (38%) have results posted.
First submitted before International Partnership for Microbicides, Inc. became part of Population Council.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women must meet all the following criteria to be eligible to enrol in the trial:
Exclusion Criteria:
Women who meet any of the following criteria are NOT eligible to enrol in the trial:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dapivirine Vaginal Ring, 25 mg.Each participant will engage in the screening process for up to 45 days prior to enrolment and will use the monthly Dapivirine Vaginal Ring for a period of up to 12 months. IPM will have the option to extend this trial period.
Drug: Dapivirine Vaginal Ring-004
To assess the safety profile of the 25 mg Dapivirine Vaginal Ring-004, when inserted at monthly intervals, in an open-label trial
Also known as: TMC-120
The Safety Profile of the 25 mg Dapivirine Vaginal Ring-004, When Inserted at Monthly Intervals. Participants Attended RC at Monthly Visits (up to Max of Three Monthly Visits) Followed by 3-monthly Follow-up Visits.
Safety assessments included adverse event (AE) reporting; all product-related AEs, Grade 3 or 4 AEs, SAEs.
Time frame: at least 12 months and up to 17 months
Adherence to the Use of the 25 mg Dapivirine Vaginal Ring-004 Inserted at Monthly Intervals, in an Open-label Trial
Determined dapivirine residual amounts in returned used vaginal rings.
Time frame: at least 12 months and up to 17 months
Incidence of HIV-1 Seroconversion
Rapid and specialised laboratory testing according to a pre-specified HIV testing algorithm
Time frame: at least 12 months and up to 17 months
Number of Participants Who Acquired HIV-1 With HIV-1 Drug Resistance-associated Mutations. Infection
Viral genotype (including NGS) resistance testing methods which include sensitive methods to detect low frequency drug-resistant variants.
Time frame: at least 12 months and up to 17 months
Up to 1,400 former IPM 027 participants were to be enrolled at 6 Research Centres (RC) - 5 RCs in SA and one RC in Uganda.
| Milestone | Dapivirine Vaginal Ring-004 |
|---|---|
| Started | 941 |
| Completed | 848 |
| Not completed | 93 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 13 |
| Withdrew: Withdrawal by subject | 57 |
| Withdrew: Non-compliance | 4 |
| Withdrew: Hiv-1 seroconversion | 18 |
Safety assessments included adverse event (AE) reporting; all product-related AEs, Grade 3 or 4 AEs, SAEs.
| Participants | Dapivirine Vaginal Ring-004 |
|---|---|
| At least one treatment emergent adverse event (TEAE) | 616 |
| At least one serious TEAE | 20 |
| At least one serious non-TEAE | 3 |
| At least one DAIDS Grade 3 or 4 TEAE | 37 |
| At least one product-related TEAE | 6 |
| TEAEs leading to death | 1 |
| TEAEs leading to temporary IP discontinuation | 2 |
| Urogenital TEAEs | 410 |
| Social harms reported as TEAEs | 8 |
| Non-TEAEs | 31 |
Determined dapivirine residual amounts in returned used vaginal rings.
| mg | Dapivirine Vaginal Ring-004 |
|---|---|
| Enrollment. The month the ring was used is defined as the month the ring was dispensed. | 20.77 ± 1.271 |
| Trial Month 1. The month the ring was used is defined as the month the ring was dispensed. | 20.57 ± 1.453 |
| Trial Month 2.The month the ring was used is defined as the month the ring was dispensed. | 20.59 ± 1.478 |
| Trial Month 3. The month the ring was used is defined as the month the ring was dispensed. | 20.83 ± 1.513 |
| Trial Month 4. The month the ring was used is defined as the month the ring was dispensed | 20.61 ± 1.503 |
| Trial Month 5. The month the ring was used is defined as the month the ring was dispensed | 20.70 ± 1.448 |
| Trial Month 6. The month the ring was used is defined as the month the ring was dispensed. | 20.77 ± 1.406 |
| Trial Month 7. The month the ring was used is defined as the month the ring was dispensed | 20.44 ± 1.445 |
| Trial Month 8. The month the ring was used is defined as the month the ring was dispensed. | 20.59 ± 1.446 |
| Trial Month 9.The month the ring was used is defined as the month the ring was dispensed. | 20.72 ± 1.583 |
| Trial Month 10. The month the ring was used is defined as the month the ring was dispensed. | 20.47 ± 1.575 |
| Trial Month 11. The month the ring was used is defined as the month the ring was dispensed. | 20.82 ± 1.626 |
| Trial Month 12. The month the ring was used is defined as the month the ring was dispensed | 20.84 ± 1.459 |
| Trial Month 13. The month the ring was used is defined as the month the ring was dispensed | 20.49 ± 1.371 |
| Trial Month 14. The month the ring was used is defined as the month the ring was dispensed. | 20.81 ± 1.355 |
| Trial Month 15. The month the ring was used is defined as the month the ring was dispensed. | 20.92 ± 1.668 |
| Trial Month 16. The month the ring was used is defined as the month the ring was dispensed. | 20.20 ± 1.273 |
Rapid and specialised laboratory testing according to a pre-specified HIV testing algorithm
| events per 100 person-years | Dapivirine Vaginal Ring-004 |
|---|---|
| Incidence of HIV-1 Seroconversion | 1.8 |
Viral genotype (including NGS) resistance testing methods which include sensitive methods to detect low frequency drug-resistant variants.
| Participants | Dapivirine Vaginal Ring-004 |
|---|---|
| Number of Participants Who Acquired HIV-1 With HIV-1 Drug Resistance-associated Mutations. Infection | 5 |
Collected over Adverse events were collected over a minimum period of 12 months and a maximum of 17 months per participant. Treatment-emergent adverse events were defined as AEs which occurred/worsened after the first insertion of the IP, up to 6 weeks after last ring use.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dapivirine Vaginal Ring-004 | 1/941 (0.1%) | 20/941 (2.1%) | 616/941 (65.5%) |
| Event | Dapivirine Vaginal Ring-004 |
|---|---|
| Stab wound, ankle fracture, fibula fracture, muscle strain, soft tissue injury, thermal burnInjury, poisoning and procedural complications | 7/941 |
| Meningitis tuberculous, Pyelonephritis, Sepsis, vuval abscessInfections and infestations | 4/941 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 2/941 |
| Hypertension, Hypertensive crisisVascular disorders | 2/941 |
| Sudden deathGeneral disorders | 1/941 |
| Diabetes mellitusMetabolism and nutrition disorders | 1/941 |
| HeadacheNervous system disorders | 1/941 |
| AnxietyPsychiatric disorders | 1/941 |
| Cervical dysplasiaReproductive system and breast disorders | 1/941 |
| Event | Dapivirine Vaginal Ring-004 |
|---|---|
| InfectionsInfections and infestations | 462/941 |
| Reproductive systemReproductive system and breast disorders | 197/941 |
| HeadacheNervous system disorders | 33/941 |
| GastritisGastrointestinal disorders | 28/941 |
| Back painMusculoskeletal and connective tissue disorders | 26/941 |
| HypertensionVascular disorders | 19/941 |
Healthy, HIV-negative women who had participated in IPM 027
| Age, Customized(years) | Dapivirine Vaginal Ring-004 |
|---|---|
| 18 - 45 years | 30.1 ± 6.32 |
| Sex: Female, Male(Participants) | Dapivirine Vaginal Ring-004 |
|---|---|
| Female | 941 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Dapivirine Vaginal Ring-004 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 931 |
| White | 0 |
| More than one race | 10 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Dapivirine Vaginal Ring-004 |
|---|---|
| South Africa | 820 |
| Uganda | 121 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dapivirine
International Partnership for Microbicides, Inc. →