PharmacokineticsPhase 1NCT01952561
Expanded Use PK of Dapivirine Vaginal Ring
A Phase 1 study testing dapivirine ring in people with Pharmacokinetics, run by International Partnership for Microbicides, Inc..
Trial summary
Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- dapivirine ring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2014
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 and ≤ 40 years of age who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the trial
- Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections, and laboratory evaluations for haematology and chemistry
- HIV-negative as determined by an HIV test at the time of enrolment
- On a stable form of contraception, defined as:
- A stable oral contraceptive regimen for at least 2 months prior to enrolment, OR
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- Transdermal contraceptive patch for at least 3 months prior to enrolment, OR
- Long-acting progestins for at least 6 months prior to enrolment, OR
- An IUD inserted at least 3 months prior to enrolment, OR
- Have undergone surgical sterilisation at least 3 months prior to enrolment AND willing to use oral contraceptives if necessary to delay menstruation during the vaginal sampling period
- Upon pelvic examination at the time of enrolment, the cervix and vagina appear normal as determined by the Investigator/Physician
- Asymptomatic for genital infections at the time of enrolment
- Willing to refrain from the use of topical vaginal medications, vaginal products or objects
- Documentation of no abnormality on cervical cytology, including grossly bloody smear, within 90 days prior to screening
- Willing to refrain from participation in any other research trial for the duration of this trial
- Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures, e.g. by home visit or telephone, or via family or close neighbour contacts
- Willing to agree to abstain from all the following for a total of 2 days (48 hours) prior to each trial visit:
- Penile-vaginal intercourse
- Oral contact with her genitalia
- Hepatitis B and C negative at the time of enrolment.
Who cannot join
- Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
- Currently breast-feeding
- Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening
- Untreated symptomatic urogenital infections, e.g. urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment
- Have a Grade 2 or higher pelvic examination finding, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence
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- Current vulvar or vaginal symptoms/abnormalities that could influence the trial results
- Cervical cytology at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
- Symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection
- Any Grade 2, 3 or 4 haematology, biochemistry or urinalysis laboratory abnormality at baseline (screening) according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;
- Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
- Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone
- Any serious acute, chronic or progressive or signs of cardiac disease, renal failure, or severe malnutrition
- Have undergone a hysterectomy
- Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
About this study
Official title: An Open-label, Parallel-group Pharmacokinetic Trial in Healthy HIV-negative Women to Characterize the Release Profile of Dapivirine Delivered by a Silicone Matrix Ring (Ring 004), Containing 25 mg of Dapivirine, Over Various Ring Use Periods
Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.
- Conditions
- Pharmacokinetics
- Being tested
- dapivirine ring
- Keywords
- pharmacokinetics, vaginal ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapivirine ringDrug
| Study group | Role | What they receive |
|---|---|---|
| 2 weeks | Experimental | Not described Receives: Drug: dapivirine ring |
| 1 week | Experimental | Not described Receives: Drug: dapivirine ring |
| 4 weeks | Experimental | Not described Receives: Drug: dapivirine ring |
| 8 weeks | Experimental | Not described Receives: Drug: dapivirine ring |
| 12 weeks | Experimental | Not described Receives: Drug: dapivirine ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
dapivirine pharmacokinetics in plasma
Measured: 1,2,4,8 or 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- None (open label)
- Enrolment
- 40 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
- NCT01952561
- Sponsor's protocol ID
- IPM 034
- Status last verified
- Sep 2013
- First submitted
- 17 Sep 2013
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel-group Pharmacokinetic Trial in Healthy HIV-negative Women to Characterize the Release Profile of Dapivirine Delivered by a Silicone Matrix Ring (Ring 004), Containing 25 mg of Dapivirine, Over Various Ring Use Periods
- ClinicalTrials.gov ID
- NCT01952561
- Acronym / sponsor ID
- IPM 034
- Conditions
- Pharmacokinetics
- Keywords
- pharmacokinetics, vaginal ring
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Sep 2013 (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.
Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2 weeks | Experimental | Drug: dapivirine ring |
| 1 week | Experimental | Drug: dapivirine ring |
| 4 weeks | Experimental | Drug: dapivirine ring |
| 8 weeks | Experimental | Drug: dapivirine ring |
| 12 weeks | Experimental | Drug: dapivirine ring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Women 18 and ≤ 40 years of age who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the trial
- Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections, and laboratory evaluations for haematology and chemistry
- HIV-negative as determined by an HIV test at the time of enrolment
- On a stable form of contraception, defined as:
Key exclusion criteria (15 listed)
- Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
- Currently breast-feeding
- Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening
- Untreated symptomatic urogenital infections, e.g. urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment
- Have a Grade 2 or higher pelvic examination finding, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;
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 ring | Drug | 1 week, 12 weeks, 2 weeks, 4 weeks, 8 weeks |
Primary outcome
dapivirine pharmacokinetics in plasma
Time frame: 1,2,4,8 or 12 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 26 Aug 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dapivirine ring in people with Pharmacokinetics, run by International Partnership for Microbicides, Inc..
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 15 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 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
dapivirine pharmacokinetics in plasma (time frame: 1,2,4,8 or 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2016.