Human Immunodeficiency VirusPhase 2NCT02028338
Study of Dapivirine Vaginal Ring (VR) in Adolescents
A Phase 2 study testing dapivirine ring in people with Human Immunodeficiency Virus, run by International Partnership for Microbicides, Inc. at 11 sites in United States.
Trial summary
To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use. Read more about this study
- Who is it for?
- Ages 15 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- dapivirine ring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 11 sitesUnited States
- Study dates
- 27 Jun 2014to 8 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 15 through 17 years (inclusive) at Enrollment, verified per site SOPs
- Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (as specified in site SOP) to be screened for and to enroll in MTN-023/IPM 030
- Able and willing to provide adequate locator information, as defined in site SOPs
- Able to communicate in spoken and written English
- Able and willing to comply with all study procedural requirements
- Per participant report at Screening and Enrollment, willing to abstain from inserting anything into the vagina for 72 hours prior to each follow-up visit, including abstaining from penile-vaginal intercourse. Note: In the event the vaginal ring has been expelled and requires reinsertion, repositioning the vaginal ring is permitted
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- In general good health as determined by the Investigator of Record (IoR)/designee at Screening and Enrollment
- Assessment of onset and progression of puberty, as measured by Tanner stage 4 or 5 at Screening, per participant report and/or clinician assessment
- HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithm in Appendix II)
- Per participant report at Screening, history of sexual intercourse (at least one episode in participant's lifetime)
- Per participant report at Screening and Enrollment, agrees to use condoms for sexual intercourse
- Negative pregnancy test at Screening and Enrollment
- 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, as defined in site SOPs)
- At Screening and Enrollment, participant states a willingness to refrain from inserting the following vaginal products and/or objects into the vagina; spermicides, diaphragms, contraceptive vaginal rings, menstrual cups, cervical caps (or any other vaginal barrier method), douches, lubricants, for the 5 days prior to Enrollment throughout the duration of study participation. Note: Neither the use of tampons or sex toys, nor participant engagement in coitus is restricted.
- At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation, unless approved by the PSRT
Who cannot join
- Per participant report at Screening, intends to do any of the following during the study participation period:
- become pregnant
- relocate away from the study site
- travel away from the study site for more than 4 consecutive weeks
- Diagnosed with a urinary tract infection (UTI) and/or reproductive tract infection (RTI) at Screening and/or Enrollment. Note: Otherwise eligible participants diagnosed with UTI during Screening will be offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 56 days of obtaining informed consent for Screening, the participant may be enrolled.
- Diagnosed with pelvic inflammatory disease and/or an sexually transmitted infection (STI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines within 60 days of Enrollment (inclusive)
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- At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff)** Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary. Note: Otherwise eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved. If improvement to a non-exclusionary grade or resolution is documented within 56 days of providing informed consent for screening, the participant may be enrolled.
- Participant report and/or clinical evidence of any of the following:
- Known adverse reaction to any of the study products (ever)
- Known HIV-infected partner
- Non-therapeutic injection drug use in the 12 months prior to Screening
- The use of HIV Post-exposure prophylaxis (PEP) and/or Pre-exposure prophylaxis (PrEP) within the 6 months prior to Enrollment
- Currently breastfeeding
- Last pregnancy outcome within 90 days or less of Screening
- Participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of Screening
- Participant report of 3 or more penile-vaginal sexual partners in the month prior to Screening
- At Enrollment, as determined by the IoR/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease
- Has any of the following Grade 1 or higher* laboratory abnormalities at Screening Visit:
- Aspartate aminotransferase (AST) or alanine transaminase (ALT)
- Creatinine
- Hemoglobin
- Platelet count Note: Otherwise eligible participants with an exclusionary test may be re-tested during the screening process. Please see the MTN-023/IPM 030 SSP for additional details.
- Has any other condition that, in the opinion of the IoR/designee, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009) **Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
The university of Colorado, 13123 E. 16th Ave., Box 025
Aurora, Colorado, 80045
The University of Colorado; 13123 E. 16th Ave., Box 025
Aurora, Colorado, 80045
Alabama CRS 84519th street south, BBRB 203A
Birmingham, Alabama, 35294-2170
The Fenway Institute, 1340 Boylston Street
Boston, Massachusetts, 02215
The Fenway Institute; 1340 Boylston Street
Boston, Massachusetts, 02215
St. Jude Children's Research Hospital 262 Danny Thomas PL.
Memphis, Tennessee, 38105
St. Jude Children's Research Hospital; 262 Danny Thomas Pl.
Memphis, Tennessee, 38105
University of Pittsburgh CRS, 3601 fifth Ave, Room 737
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh CRS, 3601 Fifth Avenue, Room 737; Falk Medical Building,
Pittsburgh, Pennsylvania, 15213
Montefiore Medical Center, 3514 Wayne Ave
The Bronx, New York, 104467
Montefiore Medical Center; 3514 Wayne Ave
The Bronx, New York, 10467
About this study
Official title: Phase 2a Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Females
To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.
Read the detailed description
MTN-023/IPM 030 is a Phase 2a, two-arm, placebo-controlled, double-blinded, multi-site, randomized trial of dapivirine vaginal ring (VR) versus placebo VR. The clinical trial is designed to assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring (primary objective) and evaluate the acceptability of the dapivirine or placebo VR in sexually experienced, HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-weeks of study product use.
Approximately 96 participants will be randomized in a 3:1 ratio to receive either a silicone elastomer vaginal ring containing 25 mg of dapivirine or a placebo VR. The ring will be replaced every 4 weeks during the 24 week study product use period.
Use of a VR to provide sustained delivery of microbicides is a novel investigational method for prevention of heterosexual transmission of HIV in women. This drug delivery method may circumvent potential difficulties related to adherence to daily or coitally-dependent uses of microbicide regimens.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- placebo ring, dapivirine ring
- Keywords
- Human Immunodeficiency Virus
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo ringCombination product
intravaginal ring silicone elastomer intravaginal ring containing no drug product
dapivirine ringCombination product
intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine ring | Experimental | dapivirine vaginal ring (25 mg) Receives: Combination Product: dapivirine ring |
| Placebo ring | Placebo comparator | silicone vaginal ring Receives: Combination Product: placebo ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Safety of Dapivirine (25 mg) Administered Via a Silicone Vaginal Ring in HIV-uninfected Adolescent Females, When Inserted Once Every 4 Weeks During 24 Weeks of Study Product Use
Grade 2 AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009), Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to IP.
Grade 3 or higher AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009).
Measured: 6 months
Secondary outcomes (4)
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Participant's self-report on multiple components of acceptability via attitudinal questions (discreetness, likes and dislikes concerning the ring, attitude toward product characteristics, comfort and ease of use, partner reactions, and effect on sex) in categorical scales
Measured: 6 months
Adherence to the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Frequency of ring removals and expulsions based on the participant's self-report of ring use at monthly clinic visits according to the Ring Adherence CRF.
Measured: 6 months
The Systemic Dapivirine Exposure
Dapivirine plasma concentrations measured at weeks 2, 4, 12 and 24.
Measured: 6 months
Local Dapivirine Exposure
Vaginal fluid dapivirine concentrations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study start27 Jun 2014
- Primary completion5 Jul 2016
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Microbicide Trials Network, National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028338
- Sponsor's protocol ID
- MTN-023/IPM 030
- Other IDs
- 11927, DAID US NIAID
- Status last verified
- Jun 2022
- First submitted
- 2 Jan 2014
- Last updated
- 24 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bunge KE, Levy L, Szydlo DW, Zhang J, Gaur AH, Reirden D, Mayer KH, Futterman D, Hoesley C, Hillier SL, Marzinke MA, Hendrix CW, Gorbach PM, Wilson CM, Soto-Torres L, Kapogiannis B, Nel A, Squires KE; MTN-023/IPM 030 Study Team. Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women. J Acquir Immune Defic Syndr. 2020 Feb 1;83(2):135-139. doi: 10.1097/QAI.0000000000002244.
PubMed 31929401
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Females
- ClinicalTrials.gov ID
- NCT02028338
- Acronym / sponsor ID
- MTN-023/IPM 030
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Microbicide Trials Network, National Institutes of Health (NIH)
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Posted 24 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.
Detailed description
MTN-023/IPM 030 is a Phase 2a, two-arm, placebo-controlled, double-blinded, multi-site, randomized trial of dapivirine vaginal ring (VR) versus placebo VR. The clinical trial is designed to assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring (primary objective) and evaluate the acceptability of the dapivirine or placebo VR in sexually experienced, HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-weeks of study product use.
Approximately 96 participants will be randomized in a 3:1 ratio to receive either a silicone elastomer vaginal ring containing 25 mg of dapivirine or a placebo VR. The ring will be replaced every 4 weeks during the 24 week study product use period.
Use of a VR to provide sustained delivery of microbicides is a novel investigational method for prevention of heterosexual transmission of HIV in women. This drug delivery method may circumvent potential difficulties related to adherence to daily or coitally-dependent uses of microbicide regimens.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapivirine ring | Experimental | Combination Product: dapivirine ringdapivirine vaginal ring (25 mg) |
| Placebo ring | Placebo comparator | Combination Product: placebo ringsilicone vaginal ring |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Age 15 through 17 years (inclusive) at Enrollment, verified per site SOPs
- Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (as specified in site SOP) to be screened for and to enroll in MTN-023/IPM 030
- Able and willing to provide adequate locator information, as defined in site SOPs
- Able to communicate in spoken and written English
- Able and willing to comply with all study procedural requirements
Key exclusion criteria (24 listed)
- Per participant report at Screening, intends to do any of the following during the study participation period:
- Diagnosed with a urinary tract infection (UTI) and/or reproductive tract infection (RTI) at Screening and/or Enrollment. Note: Otherwise eligible participants diagnosed with UTI during Screening will be offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 56 days of obtaining informed consent for Screening, the participant may be enrolled.
- Diagnosed with pelvic inflammatory disease and/or an sexually transmitted infection (STI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines within 60 days of Enrollment (inclusive)
- At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff)** Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary. Note: Otherwise eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved. If improvement to a non-exclusionary grade or resolution is documented within 56 days of providing informed consent for screening, the participant may be enrolled.
- 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 |
|---|---|---|
| placebo ringintravaginal ring silicone elastomer intravaginal ring containing no drug product | Combination product | Placebo ring |
| dapivirine ringintravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine | Combination product | Dapivirine ring |
Primary outcome
The Safety of Dapivirine (25 mg) Administered Via a Silicone Vaginal Ring in HIV-uninfected Adolescent Females, When Inserted Once Every 4 Weeks During 24 Weeks of Study Product Use
Time frame: 6 months
Grade 2 AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009), Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to IP. Grade 3 or higher AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009).
4 secondary outcomes
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Time frame: 6 months
Adherence to the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Time frame: 6 months
The Systemic Dapivirine Exposure
Time frame: 6 months
Local Dapivirine Exposure
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31929401Bunge KE, Levy L, Szydlo DW, Zhang J, Gaur AH, Reirden D, Mayer KH, Futterman D, Hoesley C, Hillier SL, Marzinke MA, Hendrix CW, Gorbach PM, Wilson CM, Soto-Torres L, Kapogiannis B, Nel A, Squires KE; MTN-023/IPM 030 Study Team. Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women. J Acquir Immune Defic Syndr. 2020 Feb 1;83(2):135-139. doi: 10.1097/QAI.0000000000002244.
- Individual participant dataSharing planned: No
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dapivirine ring in people with Human Immunodeficiency Virus, run by International Partnership for Microbicides, Inc. at 11 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 18 inclusion and 24 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 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Safety of Dapivirine (25 mg) Administered Via a Silicone Vaginal Ring in HIV-uninfected Adolescent Females, When Inserted Once Every 4 Weeks During 24 Weeks of Study Product Use (time frame: 6 months). 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 NCT02028338, which also lists 1 linked publication.
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 24 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.