Human Immunodeficiency VirusPhase 1NCT02808949
Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
A Phase 1 study testing Dapivirine in people with Human Immunodeficiency Virus, run by International Partnership for Microbicides, Inc. at 1 site in United States.
Trial summary
Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Dapivirine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 3 Mar 2018
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women must meet all of the following criteria (by self-report, unless otherwise indicated) to be eligible for inclusion in the study:
- Age 18 or older at screening as verified per site SOP
- Per participant report, at least 6 weeks postpartum at Enrollment
- Willing and able to provide written informed consent to be screened for and take part in the study
- Willing and able to provide adequate locator information, as defined in site SOP
- Willing and able to communicate in spoken and written English
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- HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results Note: HIV-1/2 screening may be omitted at Enrollment if the time between Screening and Enrollment is < 30 days
- Prior to Enrollment, breastfeeding of child has stopped
- Participant has no intention of providing expressed breast milk to her child(ren) or to others for consumption after initiation of study product Note: Providing stored breast milk to child(ren) that has been expressed prior to study product exposure is not exclusionary
- Willing and able to express breast milk at least twice daily for the duration of study drug exposure
- Per participant report, using an effective method of contraception at Enrollment, and intending to continue the use of an effective method for the duration of study participation. Effective methods for MTN-029/IPM 039 include: hormonal methods (except contraceptive VRs), intrauterine device (IUD) inserted at least 28 days prior to enrollment, engages in sex exclusively with women, sterilized (self or partner), or sexually abstinent for the past 90 days
- Women 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 to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, November 2007), or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result
- At Screening, participant states a willingness to refrain from receptive sexual activity (including penile-vaginal intercourse, anal intercourse, receptive oral intercourse, finger stimulation) and from inserting any non-study objects into the vagina (including tampons, sex toys, female condoms, diaphragms, menstrual cups, cervical caps or any other vaginal barrier method, etc.), for 24 hours prior to each clinic visit.
- At Screening, participant states a willingness to refrain from the use of vaginal products, including, spermicides, lubricants, contraceptive VRs, douches, vaginal medications, etc., for the duration of study participation
- Per participant report at Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, vaccines or breast milk sampling for the duration of study participation Note: Participation in observational studies is not exclusionary
Who cannot join
- Women who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:
- Participant report of any of the following:
- History of adverse reaction to any component of dapivirine VR
- Participation in investigational drug or device trial within 30 days prior to the Enrollment Visit (Day 0)
- Use of vaginal medication(s) 5 days prior to Enrollment (Day 0)
- Complication of lactation requiring treatment, e.g., mastitis
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- At the time of Screening and Enrollment, clinical evidence of milk supply less than 1 ounce per expression
- 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
- Grade 2 or higher AST/ALT at Screening Visit:
- Note: Otherwise eligible participants with an exclusionary AST/ALT may be retested during the screening process.
- Positive urine pregnancy test at screening or enrollment
- 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.
- Diagnosed with an STI or a reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines at Screening or Enrollment
- On pelvic exam, any of the following findings:
- Incomplete postpartum involution of the uterus
- Clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff)
- Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 5 days of Enrollment
- At Screening or Enrollment, any social or medical condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.
Read the detailed description
PK Study of the Dapivirine Vaginal Ring in Lactating Women.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Dapivirine
- Keywords
- Prevention, Lactating Women, Healthy
- 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.
DapivirineDrug
Also called Dapivirine vaginal ring
Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to wear for approximately 14 continuous days. Participants age 18 and over, at least 6 weeks postpartum, able to produce and express breast milk for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Age Groups | Experimental | Dapivirine levels in breast milk will be measured in 16 participants. All participants will wear the Dapivirine Vaginal Ring for 14 consecutive days. Receives: Drug: Dapivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
To assess the pharmacokinetics of dapivirine vaginal ring used for 14 consecutive days in lactating women
Measured: 14 Days
Secondary outcomes (2)
Safety and Tolerability of dapivirine ring in lactating women
To assess safety and tolerability of dapivirine vaginal ring used for 14 consecutive days in lactating women
Measured: 14 days
Adherence to dapivirine vaginal ring use in lactating women
To assess adherence to dapivirine vaginal ring use in lactating women
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startFeb 2015
- Primary completion3 Mar 2018
- Study completion3 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Hoesley, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808949
- Sponsor's protocol ID
- MTN-029/IPM 039
- Status last verified
- Mar 2018
- First submitted
- 18 Dec 2015
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Noguchi LM, Hoesley C, Kelly C, Scheckter R, Bunge K, Nel A, Marzinke MA, Hendrix CW, Dezzutti CS, Hillier SL, Bogen DL, Piper JM, Beigi RH. Pharmacokinetics of Dapivirine Transfer into Blood Plasma, Breast Milk, and Cervicovaginal Fluid of Lactating Women Using the Dapivirine Vaginal Ring. Antimicrob Agents Chemother. 2019 Feb 26;63(3):e01930-18. doi: 10.1128/AAC.01930-18. Print 2019 Mar.
PubMed 30602513
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
- ClinicalTrials.gov ID
- NCT02808949
- Acronym / sponsor ID
- MTN-029/IPM 039
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Prevention, Lactating Women, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 3 Mar 2018 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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.
Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.
Detailed description
PK Study of the Dapivirine Vaginal Ring in Lactating Women.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age Groups | Experimental | Drug: DapivirineDapivirine levels in breast milk will be measured in 16 participants. All participants will wear the Dapivirine Vaginal Ring for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Women must meet all of the following criteria (by self-report, unless otherwise indicated) to be eligible for inclusion in the study:
- Age 18 or older at screening as verified per site SOP
- Per participant report, at least 6 weeks postpartum at Enrollment
- Willing and able to provide written informed consent to be screened for and take part in the study
- Willing and able to provide adequate locator information, as defined in site SOP
Key exclusion criteria (18 listed)
- Women who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:
- Participant report of any of the following:
- At the time of Screening and Enrollment, clinical evidence of milk supply less than 1 ounce per expression
- 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
- Grade 2 or higher AST/ALT at Screening Visit:
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 |
|---|---|---|
| DapivirineAlso: Dapivirine vaginal ringParticipants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to wear for approximately 14 continuous days. Participants age 18 and over, at least 6 weeks postpartum, able to produce and express breast milk for 14 consecutive days. | Drug | Age Groups |
Primary outcome
Pharmacokinetics
Time frame: 14 Days
To assess the pharmacokinetics of dapivirine vaginal ring used for 14 consecutive days in lactating women
2 secondary outcomes
Safety and Tolerability of dapivirine ring in lactating women
Time frame: 14 days
Adherence to dapivirine vaginal ring use in lactating women
Time frame: 14 days
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 13 Mar 2018.
- Derived from this study: PubMed 30602513Noguchi LM, Hoesley C, Kelly C, Scheckter R, Bunge K, Nel A, Marzinke MA, Hendrix CW, Dezzutti CS, Hillier SL, Bogen DL, Piper JM, Beigi RH. Pharmacokinetics of Dapivirine Transfer into Blood Plasma, Breast Milk, and Cervicovaginal Fluid of Lactating Women Using the Dapivirine Vaginal Ring. Antimicrob Agents Chemother. 2019 Feb 26;63(3):e01930-18. doi: 10.1128/AAC.01930-18. Print 2019 Mar.
- 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.
Craig Hoesley, MD principal investigator
University of Pittsburgh
1 site 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 in people with Human Immunodeficiency Virus, run by International Partnership for Microbicides, Inc. at 1 site 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 15 inclusion and 18 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pharmacokinetics (time frame: 14 Days). 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 NCT02808949, 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 13 Mar 2018.