HIV-1-infectionPhase 1NCT03234400
A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
A Phase 1 study testing Dapivirine Vaginal Ring, 25 mg, Dapivirine Vaginal Ring, 100 mg and Dapivirine Vaginal Ring, 200 mg in people with HIV-1-infection, run by International Partnership for Microbicides, Inc. at 2 sites in United States.
Trial summary
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Dapivirine Vaginal Ring, 25 mg, Dapivirine Vaginal Ring, 100 mg and Dapivirine Vaginal Ring, 200 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2017to 23 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Assigned female sex at birth Note: Participants who are female at birth, who now identify as male, will not be excluded so long as they are not on female-to-male transition therapy.
- Age 18 through 45 years (inclusive) at Screening, verified per site SOPs
- Able and willing to provide written informed consent to be screened for and enrolled in MTN-036/IPM 047
- Able and willing to provide adequate locator information, as defined in site SOPs
- Able to communicate in spoken and written English
- Available for all visits and able and willing to comply with all study procedural requirements
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- Willing to comply with abstinence and other protocol requirements
- Willing to use male condoms for penile-vaginal intercourse (PVI) and penile-rectal intercourse for the duration of study participation
- Per participant report, using an effective method of contraception for at least 30 days (inclusive) prior to Enrollment, and intending to continue use of an effective method for the duration of study participation; effective methods include:
- hormonal methods (except contraceptive ring)
- intrauterine device (IUD)
- sterilization (of participant or partner, as defined in site SOPs)
- having sex exclusively with cis-women
- abstinence from PVI for 90 days prior to Enrollment, and intending to remain abstinent from PVI for the duration of study participation
- HIV-uninfected based on testing performed at Screening and Enrollment
- Per participant report at Screening, regular menstrual cycles with at least 21 days between menses Note: This criterion is not applicable to participants who report using a progestin-only method of contraception at Screening (e.g., Depo-Provera or levonorgestrel-releasing IUD) nor to participants using continuous combination oral contraceptive pills, as the absence of regular menstrual cycles is an expected, normal consequence in this context.
- Per participant report at Screening and Enrollment, states a willingness to refrain from inserting any non-study vaginal products or objects into the vagina including, but not limited to spermicides, female condoms, diaphragms, intravaginal rings, vaginal medications, menstrual cups, cervical caps, douches, lubricants, and sex toys (vibrators, dildos, etc.) for the 24 hours preceding the Enrollment Visit and for the duration of study participation.
- Note: Use of tampons is permitted except for 24 hours prior to clinic visits in which CVF samples are scheduled to be collected.
- Participants over the age of 21 (inclusive) must have documentation of a satisfactory Pap within the past 3 years prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.1, March 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result
- At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products or vaccines after the Screening Visit and for the duration of study participation
Who cannot join
- Pregnant at Screening or Enrollment or plans to become pregnant during the study period
- Diagnosed with a UTI or reproductive tract infection (RTI) at Screening or Enrollment
- Diagnosed with an acute STI requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment/) at Screening or Enrollment such as gonorrhea (GC), CT, trichomonas, PID, and/or syphilis
- Has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) at Screening or Enrollment, as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007])
- 5) Participant report and/or clinical evidence of any of the following:
- Known adverse reaction to any of the study products (ever)
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- Chronic and/or recurrent vaginal candidiasis
- Non-therapeutic injection drug use in the 12 months prior to Enrollment
- Last pregnancy outcome less than 90 days prior to Enrollment
- Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) 45 days or less prior to Enrollment Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap test as well as IUD insertion/removal are not exclusionary.
- Currently breastfeeding or planning to breastfeed during the study period
- Participation in any other research study involving drugs, medical devices, vaginal products or vaccines, in the 60 days prior to Enrollment
- Use of pre-exposure prophylaxis (PrEP) for HIV prevention and/or post-exposure prophylaxis (PEP) for potential HIV exposure within the 3 months prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation
- Has any of the following Grade 1 or higher laboratory abnormalities at Screening Visit:
- AST or ALT
- Hemoglobin
- Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objectives including any significant uncontrolled active or chronic medical condition.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Bridge HIV CRS San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.
Read the detailed description
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, and those randomized to the 100 mg and 200 mg VRs will not be told their group assignment. Participants will insert one VR to be used continuously for 13 weeks (100 mg VR or 200 mg VR) or one VR (25 mg VR) to be replaced every 4 weeks for 8 weeks, then worn for an additional 5 weeks for a total of 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal.
- Conditions
- HIV-1-infection
- Being tested
- Dapivirine Vaginal Ring, 25 mg, Dapivirine Vaginal Ring, 100 mg, Dapivirine Vaginal Ring, 200 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapivirine Vaginal Ring, 25 mgCombination product
Vaginal Ring containing 25 mg dapivirine
Dapivirine Vaginal Ring, 100 mgCombination product
Vaginal Ring containing 100 mg dapivirine
Dapivirine Vaginal Ring, 200 mgCombination product
Vaginal Ring containing 200 mg dapivirine
| Study group | Role | What they receive |
|---|---|---|
| 25 mg Dapivirine Vaginal Ring | Experimental | Participants will insert one Dapivirine Vaginal Ring, 25 mg to be replaced every 4 weeks for 8 weeks, then worn for an additional 5 weeks for a total of 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal. Receives: Combination Product: Dapivirine Vaginal Ring, 25 mg |
| 100 mg Dapivirine Vaginal Ring | Experimental | Participants will insert one Dapivirine Vaginal Ring, 100 mg to be used continuously for 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal. Receives: Combination Product: Dapivirine Vaginal Ring, 100 mg |
| 200 mg Dapivirine Vaginal Ring | Experimental | Participants will insert one Dapivirine Vaginal Ring, 200 mg to be used continuously for 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal. Receives: Combination Product: Dapivirine Vaginal Ring, 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
DPV concentration in plasma.
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
Measured: 13 weeks
DPV concentration in cervicovaginal fluid
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
Measured: 13 weeks
DPV concentration in cervical tissue
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
Measured: 13 weeks
Safety comparison of the two extended duration DPV VRs (100 mg and 200 mg) to the current 25 mg DPV VR
- Proportions of participants with Grade 2 or higher genitourinary adverse events as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007])
- Proportions of participants with Grade 3 or higher adverse events as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Measured: 13 weeks
Secondary outcomes (3)
Adherence
- Frequency of study VR removal/expulsions (voluntary and involuntary) and duration without VR in vagina (by self-report)
Measured: 13 weeks
Adherence
- VR use initiation and persistence (whether the VR is in place when participants come to the clinic for their study visits)
Measured: 13 weeks
Acceptability
Degree to which study participants liked or disliked using the three DPV VRs (by self-report)
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start4 Dec 2017
- Primary completion23 Oct 2018
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234400
- Sponsor's protocol ID
- MTN-036/IPM 047
- Other IDs
- 5UM1AI068633
- Status last verified
- Jan 2019
- First submitted
- 25 Jul 2017
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Hawley I, Song M, Scheckter R, McClure T, Piper J, Chen BA, Hoesley C, Liu AY, van der Straten A. Users' Preferred Characteristics of Vaginal Rings for HIV Prevention: A Qualitative Analysis of Two Phase I Trials. AIDS Res Hum Retroviruses. 2022 Apr;38(4):313-326. doi: 10.1089/AID.2021.0077. Epub 2022 Feb 11.
PubMed 34969254Liu AY, Dominguez Islas C, Gundacker H, Neradilek B, Hoesley C, van der Straten A, Hendrix CW, Beamer M, Jacobson CE, McClure T, Harrell T, Bunge K, Devlin B, Nuttall J, Spence P, Steytler J, Piper JM, Marzinke MA; MTN-036/IPM 047 Protocol Team for the Microbicide Trials Network. Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States. J Int AIDS Soc. 2021 Jun;24(6):e25747. doi: 10.1002/jia2.25747.
PubMed 34118115
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
- ClinicalTrials.gov ID
- NCT03234400
- Acronym / sponsor ID
- MTN-036/IPM 047
- Conditions
- HIV-1-infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.
Detailed description
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, and those randomized to the 100 mg and 200 mg VRs will not be told their group assignment. Participants will insert one VR to be used continuously for 13 weeks (100 mg VR or 200 mg VR) or one VR (25 mg VR) to be replaced every 4 weeks for 8 weeks, then worn for an additional 5 weeks for a total of 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 mg Dapivirine Vaginal Ring | Experimental | Combination Product: Dapivirine Vaginal Ring, 25 mgParticipants will insert one Dapivirine Vaginal Ring, 25 mg to be replaced every 4 weeks for 8 weeks, then worn for an additional 5 weeks for a total of 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal. |
| 100 mg Dapivirine Vaginal Ring | Experimental | Combination Product: Dapivirine Vaginal Ring, 100 mgParticipants will insert one Dapivirine Vaginal Ring, 100 mg to be used continuously for 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal. |
| 200 mg Dapivirine Vaginal Ring | Experimental | Combination Product: Dapivirine Vaginal Ring, 200 mgParticipants will insert one Dapivirine Vaginal Ring, 200 mg to be used continuously for 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Assigned female sex at birth Note: Participants who are female at birth, who now identify as male, will not be excluded so long as they are not on female-to-male transition therapy.
- Age 18 through 45 years (inclusive) at Screening, verified per site SOPs
- Able and willing to provide written informed consent to be screened for and enrolled in MTN-036/IPM 047
- Able and willing to provide adequate locator information, as defined in site SOPs
- Able to communicate in spoken and written English
Key exclusion criteria (17 listed)
- Pregnant at Screening or Enrollment or plans to become pregnant during the study period
- Diagnosed with a UTI or reproductive tract infection (RTI) at Screening or Enrollment
- Diagnosed with an acute STI requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment/) at Screening or Enrollment such as gonorrhea (GC), CT, trichomonas, PID, and/or syphilis
- Has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) at Screening or Enrollment, as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007])
- 5) Participant report and/or clinical evidence of any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapivirine Vaginal Ring, 25 mgVaginal Ring containing 25 mg dapivirine | Combination product | 25 mg Dapivirine Vaginal Ring |
| Dapivirine Vaginal Ring, 100 mgVaginal Ring containing 100 mg dapivirine | Combination product | 100 mg Dapivirine Vaginal Ring |
| Dapivirine Vaginal Ring, 200 mgVaginal Ring containing 200 mg dapivirine | Combination product | 200 mg Dapivirine Vaginal Ring |
Primary outcome
DPV concentration in plasma.
Time frame: 13 weeks
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
DPV concentration in cervicovaginal fluid
Time frame: 13 weeks
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
DPV concentration in cervical tissue
Time frame: 13 weeks
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
Safety comparison of the two extended duration DPV VRs (100 mg and 200 mg) to the current 25 mg DPV VR
Time frame: 13 weeks
* Proportions of participants with Grade 2 or higher genitourinary adverse events as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]) * Proportions of participants with Grade 3 or higher adverse events as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
3 secondary outcomes
Adherence
Time frame: 13 weeks
Adherence
Time frame: 13 weeks
Acceptability
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 34969254Hawley I, Song M, Scheckter R, McClure T, Piper J, Chen BA, Hoesley C, Liu AY, van der Straten A. Users' Preferred Characteristics of Vaginal Rings for HIV Prevention: A Qualitative Analysis of Two Phase I Trials. AIDS Res Hum Retroviruses. 2022 Apr;38(4):313-326. doi: 10.1089/AID.2021.0077. Epub 2022 Feb 11.
- Derived from this study: PubMed 34118115Liu AY, Dominguez Islas C, Gundacker H, Neradilek B, Hoesley C, van der Straten A, Hendrix CW, Beamer M, Jacobson CE, McClure T, Harrell T, Bunge K, Devlin B, Nuttall J, Spence P, Steytler J, Piper JM, Marzinke MA; MTN-036/IPM 047 Protocol Team for the Microbicide Trials Network. Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States. J Int AIDS Soc. 2021 Jun;24(6):e25747. doi: 10.1002/jia2.25747.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapivirine Vaginal Ring, 25 mg, Dapivirine Vaginal Ring, 100 mg and Dapivirine Vaginal Ring, 200 mg in people with HIV-1-infection, run by International Partnership for Microbicides, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DPV concentration in plasma. (time frame: 13 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03234400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.