Human Immunodeficiency VirusPhase 2NCT02010593
Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
A Phase 2 study testing Dapivirine Vaginal Ring in people with Human Immunodeficiency Virus, run by International Partnership for Microbicides, Inc. at 3 sites in United States.
Trial summary
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Dapivirine Vaginal Ring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2013to Apr 2015
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45 through 65 years (inclusive) at Screening, verified per site SOPs
- Per participant report, postmenopausal at Screening, defined as amenorrhoeic for the past 12 months (minimum) or at least 6 months status post-bilateral oophorectomy
- Follicle-stimulating hormone (FSH) level at 40 mIU/ml or higher at Screening
- Able and willing to provide written informed consent to be screened for and enrolled in MTN-024/IPM 031
- Able to communicate in spoken and written English
- Able and willing to comply with all study procedural requirements
Show all 19Show fewer
- Willing to only use study provided and/or approved vaginal products throughout the duration of study participation.
- Willing to abstain from inserting study approved lubricant into the vagina for 72 hours prior to each visit
- Willing to abstain from vaginal intercourse for 72 hours prior to each visit
- In general good health as determined by the Investigator of Record (IoR)/designee at Screening and Enrollment
- Able and willing to provide adequate locator information, as defined in site SOPs
- HIV-uninfected based on testing performed at Screening (per protocol algorithm in Appendix II)
- Per participant report at Screening and Enrollment, agrees to use male latex condoms for sexual intercourse
- 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, topical or systemic hormone replacement therapy, including vaginal estrogens, and/or hormonal contraceptives, vaginal medications, menstrual cups, cervical caps (or any other vaginal barrier method), vaginal douches, lubricants and moisturizers, sex toys (vibrators, dildos, etc.), for the duration of the study participation.
- Note: Use of study approved lubricant is permitted.
- 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
- Participants in the biopsy subset must also meet the following criteria at Screening to be eligible for inclusion:
- Willing to abstain from inserting anything into the vagina for 72 hours following the collection of biopsies, including abstaining from vaginal intercourse
- Anatomy sufficient for the collection of cervical biopsies
Who cannot join
- Per participant report at screening:
- Plans to relocate away from the study site during study participation
- Plans to travel away from the study site for more than 4 consecutive weeks during study participation
- Pregnant at screening Note: A documented negative pregnancy test performed by study staff is required for inclusion; however a self-reported pregnancy is adequate for exclusion from the study.
- Diagnosed with urinary tract infection (UTI) at Screening or Enrollment Note: Otherwise eligible participants diagnosed with UTI during screening are offered treatment and may be enrolled after completing treatment and all symptoms have resolved.
- If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.
Show all 31Show fewer
- Diagnosed with pelvic inflammatory disease, an STI or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines at Screening or Enrollment Note: Otherwise eligible participants diagnosed during screening with pelvic inflammatory disease or STI/RTI requiring treatment per CDC guidelines - other than asymptomatic bacterial vaginosis (BV) and asymptomatic candidiasis - are offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled. Genital warts requiring treatment also must be treated prior to Enrollment. Genital warts requiring therapy are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort.
- Has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) at Screening or Enrollment, as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies 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 Investigator of Record (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 45 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 adverse reaction to latex (ever)
- Chronic and/or recurrent vaginal candidiasis
- Topical or systemic hormone replacement therapy and/or hormonal contraception within the 6 months prior to Enrollment
- Non-therapeutic injection drug use in the 12 months prior to Enrollment
- Post-exposure prophylaxis (PEP) for HIV exposure within the 6 months prior to Enrollment
- Pre-exposure prophylaxis (PrEP) for HIV prevention within the 6 months prior to Enrollment
- Last pregnancy outcome 6 months or less prior to Enrollment
- Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) 90 days or less prior to Enrollment
- Currently breastfeeding
- At Screening, severe pelvic relaxation such that either the vaginal walls or the uterine cervix descend beyond the vaginal introitus with Valsalva maneuver
- Participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, in the 45 days prior to Enrollment
- As determined by the IoR/designee, 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 laboratory abnormalities at Screening Visit:
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
- Creatinine Grade 2 or higher*
- Hemoglobin Grade 2 or higher*
- Platelet count Grade 1 or higher*
- Pap result Grade 2 or higher** Note: Otherwise eligible participants with an exclusionary test may be re-tested during the screening process.
- Note: Women with a documented normal result within the 12 months prior to Enrollment need not have a Pap smear during the screening period. Women with a Grade 1 abnormal Pap smear can be enrolled upon completion of the initial phase of evaluation if no current treatment is indicated (based on local standard of care for management of abnormal cervical cytology). Need for a repeat Pap within 6 months does not preclude Enrollment prior to that result becoming available. If the participant has had a hysterectomy for reasons not related to cervical dysplasia, a Pap smear need not be performed.
- 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 *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 Division of AIDS (DAIDS) Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alabama CRS, 84519th Street South, BBRB 203A
Birmingham, Alabama, 35294-2170
Case CRS, Case Western Reserve University, 2061 Cornell Road, Room 303
Cleveland, Ohio, 44106
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase 2a Safety Study of a Vaginal Matrix Ring Containing Dapivirine in a Postmenopausal Female Population
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.
Read the detailed description
Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted diamino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-[[4-[(2,4,6-trimethylphenyl)amino]-2- pyrimidinyl]amino]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR, as evidenced by favorable safety and pharmacokinetic data to date described below.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Dapivirine Vaginal Ring, Placebo Vaginal Ring
- 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.
Dapivirine Vaginal RingDrug
Also called TMC-120
Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted amino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-[[4-[(2,4,6-trimethylphenyl)amino]-2- pyrimidinyl]amino]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR
Placebo Vaginal RingDrug
The placebo VR is a flexible, platinum-catalyzed-cured silicone matrix ring, identical to dapivirine Ring-004, containing no active drug.
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine Vaginal Ring | Experimental | Safety study of a vaginal ring containing Dapivirine in a postmenopausal female population Receives: Drug: Dapivirine Vaginal Ring |
| Placebo | Placebo comparator | The placebo VR is a flexible, platinum-catalyzed-cured matrix ring, identical to Dapivirine Ring-004, containing no active-drug Receives: Drug: Placebo Vaginal Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Dapivirine (25 mg) Administered in a Silicone Elastomer Vaginal Matrix Ring in HIV-uninfected Postmenopausal Women, When Inserted Once Every 4 Weeks During 12 Weeks of Study Product Use
Evidence of Grade 2 or higher genital, genitourinary and reproductive system AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009), Addendum 1, (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to study product.
Evidence of Grade 3 or higher AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009).
DAIDS severity grades are defined as follows:
- Grade 1 = mild
- Grade 2 = moderate
- Grade 3 = severe
- Grade 4 = potentially life-threatening
- Grade 5 = death
Measured: over 12-week period of use
Secondary outcomes (4)
The Percentage of Participants Who Find the Study Vaginal Ring to be as Acceptable
To evaluate the acceptability, the percentage of participants who at their 12-Week Final Clinic Visit report via acceptability questionnaire that they prefer the ring at least as much as other HIV prevention methods.
Measured: at 12-week visit
Percentage of Women Who Were Adherent to Daily Study Product Use Based on Self-report Over the 12-week Study Product Use Period
Adherence will be measured by the percentage of women who keep the VR inserted at all times in the vagina over the course of 12 weeks.
A participant was considered adherent in one month (4 weeks) by self-reported data, only if the ring was never out during that month and the participant was not on product hold and did not terminate the clinical trial within that month.
Measured: 12-week period of use
Pharmacokinetics - The Intent is to Determine if the Plasma Dapivirine Concentrations Are Different in Postmenopausal Women Than in Pre-menopausal Adult Women After Placement of Dapivirine Vaginal Rings.
The PK endpoint is a description of the end of period (28 day post ring insertion) plasma dapivirine concentrations at week 4, 8, and 12 which will be compared to the same results in a recently studied population of premenopausal adult women (MTN-013).
Measured: a 12 week product use period
Pharmacokinetics - The Intent is to Determine if the Vaginal Fluid Dapivirine Concentrations Are Different in Postmenopausal Women Than in Pre-menopausal Adult Women After Placement of Dapivirine Vaginal Rings.
The PK endpoint is a description of the end of period (28 day post ring insertion) vaginal fluid dapivirine concentrations at week 4, 8, and 12 which will be compared to the same results in a recently studied population of premenopausal adult women (MTN-013).
Measured: a 12 week product use period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2015
- Study completionApr 2015
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 (2)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010593
- Sponsor's protocol ID
- MTN-024/IPM031
- Other IDs
- 5UM1AI068633-07
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2013
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shapley-Quinn MK, Laborde N, Luecke E, Hoesley C, Salata RA, Johnson S, Nel A, Soto-Torres L, Chen BA, van der Straten A. Acceptability of the Dapivirine Vaginal Ring in Postmenopausal US Women. AIDS Patient Care STDS. 2022 Mar;36(3):97-105. doi: 10.1089/apc.2022.0002.
PubMed 35289688Chen BA, Zhang J, Gundacker HM, Hendrix CW, Hoesley CJ, Salata RA, Dezzutti CS, van der Straten A, Hall WB, Jacobson CE, Johnson S, McGowan I, Nel AM, Soto-Torres L, Marzinke MA; MTN-024/IPM 031 Protocol Team for the Microbicide Trials Network. Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women. Clin Infect Dis. 2019 Mar 19;68(7):1144-1151. doi: 10.1093/cid/ciy654.
PubMed 30289485
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Safety Study of a Vaginal Matrix Ring Containing Dapivirine in a Postmenopausal Female Population
- ClinicalTrials.gov ID
- NCT02010593
- Acronym / sponsor ID
- MTN-024/IPM031
- Conditions
- 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
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Posted 5 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.
Detailed description
Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted diamino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-[[4-[(2,4,6-trimethylphenyl)amino]-2- pyrimidinyl]amino]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR, as evidenced by favorable safety and pharmacokinetic data to date described below.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapivirine Vaginal Ring | Experimental | Drug: Dapivirine Vaginal RingSafety study of a vaginal ring containing Dapivirine in a postmenopausal female population |
| Placebo | Placebo comparator | Drug: Placebo Vaginal RingThe placebo VR is a flexible, platinum-catalyzed-cured matrix ring, identical to Dapivirine Ring-004, containing no active-drug |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 45 through 65 years (inclusive) at Screening, verified per site SOPs
- Per participant report, postmenopausal at Screening, defined as amenorrhoeic for the past 12 months (minimum) or at least 6 months status post-bilateral oophorectomy
- Follicle-stimulating hormone (FSH) level at 40 mIU/ml or higher at Screening
- Able and willing to provide written informed consent to be screened for and enrolled in MTN-024/IPM 031
- Able to communicate in spoken and written English
Key exclusion criteria (31 listed)
- Per participant report at screening:
- Pregnant at screening Note: A documented negative pregnancy test performed by study staff is required for inclusion; however a self-reported pregnancy is adequate for exclusion from the study.
- Diagnosed with urinary tract infection (UTI) at Screening or Enrollment Note: Otherwise eligible participants diagnosed with UTI during screening are offered treatment and may be enrolled after completing treatment and all symptoms have resolved.
- If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.
- Diagnosed with pelvic inflammatory disease, an STI or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines at Screening or Enrollment Note: Otherwise eligible participants diagnosed during screening with pelvic inflammatory disease or STI/RTI requiring treatment per CDC guidelines - other than asymptomatic bacterial vaginosis (BV) and asymptomatic candidiasis - are offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled. Genital warts requiring treatment also must be treated prior to Enrollment. Genital warts requiring therapy are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort.
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 RingAlso: TMC-120Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted amino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-[[4-[(2,4,6-trimethylphenyl)amino]-2- pyrimidinyl]amino]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR | Drug | Dapivirine Vaginal Ring |
| Placebo Vaginal RingThe placebo VR is a flexible, platinum-catalyzed-cured silicone matrix ring, identical to dapivirine Ring-004, containing no active drug. | Drug | Placebo |
Primary outcome
Safety of Dapivirine (25 mg) Administered in a Silicone Elastomer Vaginal Matrix Ring in HIV-uninfected Postmenopausal Women, When Inserted Once Every 4 Weeks During 12 Weeks of Study Product Use
Time frame: over 12-week period of use
Evidence of Grade 2 or higher genital, genitourinary and reproductive system AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009), Addendum 1, (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to study product. Evidence of Grade 3 or higher AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009). DAIDS severity grades are defined as follows: * Grade 1 = mild * Grade 2 = moderate * Grade 3 = severe * Grade 4 = potentially life-threatening * Grade 5 = death
4 secondary outcomes
The Percentage of Participants Who Find the Study Vaginal Ring to be as Acceptable
Time frame: at 12-week visit
Percentage of Women Who Were Adherent to Daily Study Product Use Based on Self-report Over the 12-week Study Product Use Period
Time frame: 12-week period of use
Pharmacokinetics - The Intent is to Determine if the Plasma Dapivirine Concentrations Are Different in Postmenopausal Women Than in Pre-menopausal Adult Women After Placement of Dapivirine Vaginal Rings.
Time frame: a 12 week product use period
Pharmacokinetics - The Intent is to Determine if the Vaginal Fluid Dapivirine Concentrations Are Different in Postmenopausal Women Than in Pre-menopausal Adult Women After Placement of Dapivirine Vaginal Rings.
Time frame: a 12 week product use period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35289688Shapley-Quinn MK, Laborde N, Luecke E, Hoesley C, Salata RA, Johnson S, Nel A, Soto-Torres L, Chen BA, van der Straten A. Acceptability of the Dapivirine Vaginal Ring in Postmenopausal US Women. AIDS Patient Care STDS. 2022 Mar;36(3):97-105. doi: 10.1089/apc.2022.0002.
- Derived from this study: PubMed 30289485Chen BA, Zhang J, Gundacker HM, Hendrix CW, Hoesley CJ, Salata RA, Dezzutti CS, van der Straten A, Hall WB, Jacobson CE, Johnson S, McGowan I, Nel AM, Soto-Torres L, Marzinke MA; MTN-024/IPM 031 Protocol Team for the Microbicide Trials Network. Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women. Clin Infect Dis. 2019 Mar 19;68(7):1144-1151. doi: 10.1093/cid/ciy654.
- 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.
3 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 Vaginal Ring in people with Human Immunodeficiency Virus, run by International Partnership for Microbicides, Inc. at 3 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 19 inclusion and 31 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 5 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?
Safety of Dapivirine (25 mg) Administered in a Silicone Elastomer Vaginal Matrix Ring in HIV-uninfected Postmenopausal Women, When Inserted Once Every 4 Weeks During 12 Weeks of Study Product Use (time frame: over 12-week period of use). 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 NCT02010593, 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 3 Nov 2022.