HIVPhase 1NCT02858024
A Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
A Phase 1 study testing Dapivirine Vaginal Ring-004 and no tampons, Dapivirine Vaginal Ring-004 with tampons and Dapivirine Vaginal Ring-004 with no menses in people with HIV, run by International Partnership for Microbicides, Inc..
Trial summary
A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine 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
- What is being tested?
- Dapivirine Vaginal Ring-004 and no tampons, Dapivirine Vaginal Ring-004 with tampons and Dapivirine Vaginal Ring-004 with no menses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2015to 16 Apr 2016
- 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
- Participants must meet all the following criteria to be eligible to enroll in the trial:
- 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 (dipstick and microscopy [if indicated]), laboratory evaluations for genital infections (bacterial vaginosis, gonorrhoea, chlamydia, and trichomonas), and laboratory evaluations for haematology and biochemistry;
- HIV-negative as determined by an HIV test at screening;
- On a stable oral contraceptive regimen for at least three months prior to screening;
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- Upon pelvic examination at the time of enrollment, the cervix and vagina appear normal as determined by the Investigator/Physician;
- Asymptomatic for genital infections at the time of enrollment (if a woman is diagnosed with any treatable STI, either clinically or by laboratory test at the time of screening, she must have completed treatment before the date of enrollment);
- Willing to refrain from the use of topical vaginal medications, vaginal products or objects, including female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, and drying agents for seven days prior to enrollment and for the duration of the trial;
- Willing to refrain from tampon use during menses for the entire duration of the trial, other than when assigned to Treatment B (Cohort I);
- 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 neighbor contacts (confidentiality to be maintained);
- 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 enrollment.
Who cannot join
- Participants who meet any of the following criteria are NOT eligible to enrol in the trial:
- Currently pregnant or had their last pregnancy outcome within three 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 STIs, or other gynaecological conditions such as vaginal itching, pain, or discharge, within two weeks prior to enrollment;
- Have a Grade 2 or higher pelvic examination finding, according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies;
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- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence;
- 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; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies;
- Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment;
- 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 disease (e.g. any known history of neoplasm, cancer, diabetes, epilepsy, cardiac disease, autoimmune disease, HIV, AIDS, or blood dyscrasias), or signs of cardiac disease, renal failure, or severe malnutrition;
- Have undergone a hysterectomy and/or bilateral oophorectomy and/or presented with amenorrhea within 90 days prior to enrollment;
- 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: A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
- Conditions
- HIV
- Being tested
- Dapivirine Vaginal Ring-004 and no tampons, Dapivirine Vaginal Ring-004 with tampons, Dapivirine Vaginal Ring-004 with no menses, Dapivirine Vaginal Ring-004 and same ring inserted after menses, Dapivirine Vaginal Ring-004 and new ring inserted after menses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapivirine Vaginal Ring-004 and no tamponsDrug
Also called Treatment A
Dapivirine Vaginal Ring-004 for 28 days, with menses, no tampon use (Treatment A),
Dapivirine Vaginal Ring-004 with tamponsDrug
Also called Treatment B
followed by Dapivirine Vaginal Ring-004 for 28 days, with menses, with tampon use (Treatment B)
Dapivirine Vaginal Ring-004 with no mensesDrug
Also called Treatment E
Dapivirine Vaginal Ring-004 for 28 days, with no menses occurring (Treatment E; treatment period 3).
Dapivirine Vaginal Ring-004 and same ring inserted after mensesDrug
Also called Treatment C
Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and the same ring re-inserted five days later (estimated completion of menses) (Treatment C)
Dapivirine Vaginal Ring-004 and new ring inserted after mensesDrug
Also called Treatment D
Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and a new ring inserted five days later (estimated completion of menses) (Treatment D)
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | Active comparator | In Cohort I, eligible participants will be randomly assigned to one of two treatment sequences (ABE or BAE). During two consecutive 28-day treatment periods (treatment periods 1 and 2), separated by a washout period of 28 days, the participants will receive each of the following treatments according to their assigned treatment sequence Receives: Drug: Dapivirine Vaginal Ring-004 and no tampons; Drug: Dapivirine Vaginal Ring-004 with tampons; Drug: Dapivirine Vaginal Ring-004 with no menses |
| Cohort II | Active comparator | In Cohort II, eligible participants will be randomly assigned to one of two treatment sequences (CDE or DCE). During two consecutive 28-day treatment periods (treatment periods 1 and 2), separated by a washout period of 28 days, the participants will receive each of the following treatments according to their assigned treatment sequence Receives: Drug: Dapivirine Vaginal Ring-004 with no menses; Drug: Dapivirine Vaginal Ring-004 and same ring inserted after menses; Drug: Dapivirine Vaginal Ring-004 and new ring inserted after menses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dapivirine concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses, when no tampons are used, during a 28-day ring use period.
To determine the effect of menses on the local and systemic pharmacokinetics (PK) of dapivirine, delivered by the Dapivirine Vaginal Ring-004, in healthy, HIV-negative women
Measured: 28 days
Dapivirine concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses, when tampons are used, during a 28-day ring use period.
To determine the effect of tampon use during menses on the local and systemic PK of dapivirine, delivered by the Dapivirine Vaginal Ring-004, in healthy, HIV-negative women.
Measured: 28 days
Secondary outcomes (4)
Dapivirine concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses when the ring is removed at the onset of menses, and re-inserted after completion of menses for the remainder of a 28-day period.
To assess the impact on the local and systemic PK of dapivirine, delivered by the Dapivirine Vaginal Ring-004 when the ring is removed at the start of menses, and re-inserted after completion of menses.
Measured: 28 days
Dapivirine concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses when the ring is removed at the onset of menses, and a new ring inserted after completion of menses
To assess the impact on the local and systemic PK of dapivirine, delivered by the Dapivirine Vaginal Ring-004 when the ring is removed at the start of menses, and a new ring inserted after completion of menses.
Measured: 28 days
The residual amounts of dapivirine in used vaginal rings, removed at the onset of menses, where applicable, or on Day 28.
To assess residual levels of dapivirine in used rings.
Measured: 28 days
Safety will be assessed through the reporting of AEs, including SAEs, laboratory safety assessments (haematology, biochemistry, and urinalysis), physical and gynaecological examinations, and vaginal flora and pH assessments during the trial.
To assess the safety of the Dapivirine Vaginal Ring-004 in healthy, HIV-negative women.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start12 Jan 2015
- Primary completion16 Apr 2016
- Study completion16 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02858024
- Sponsor's protocol ID
- IPM 035
- Status last verified
- Sep 2017
- First submitted
- 19 Jul 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
- ClinicalTrials.gov ID
- NCT02858024
- Acronym / sponsor ID
- IPM 035
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 16 Apr 2016 (actual)
- Study completion
- 16 Apr 2016 (actual)
- First posted
- 8 Aug 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.
A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I | Active comparator | Drug: Dapivirine Vaginal Ring-004 and no tampons, Drug: Dapivirine Vaginal Ring-004 with tampons, Drug: Dapivirine Vaginal Ring-004 with no mensesIn Cohort I, eligible participants will be randomly assigned to one of two treatment sequences (ABE or BAE). During two consecutive 28-day treatment periods (treatment periods 1 and 2), separated by a washout period of 28 days, the participants will receive each of the following treatments according to their assigned treatment sequence |
| Cohort II | Active comparator | Drug: Dapivirine Vaginal Ring-004 with no menses, Drug: Dapivirine Vaginal Ring-004 and same ring inserted after menses, Drug: Dapivirine Vaginal Ring-004 and new ring inserted after mensesIn Cohort II, eligible participants will be randomly assigned to one of two treatment sequences (CDE or DCE). During two consecutive 28-day treatment periods (treatment periods 1 and 2), separated by a washout period of 28 days, the participants will receive each of the following treatments according to their assigned treatment sequence |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 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 (dipstick and microscopy [if indicated]), laboratory evaluations for genital infections (bacterial vaginosis, gonorrhoea, chlamydia, and trichomonas), and laboratory evaluations for haematology and biochemistry;
- HIV-negative as determined by an HIV test at screening;
- On a stable oral contraceptive regimen for at least three months prior to screening;
Key exclusion criteria (16 listed)
- Participants who meet any of the following criteria are NOT eligible to enrol in the trial:
- Currently pregnant or had their last pregnancy outcome within three 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 STIs, or other gynaecological conditions such as vaginal itching, pain, or discharge, within two weeks prior to enrollment;
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-004 and no tamponsAlso: Treatment ADapivirine Vaginal Ring-004 for 28 days, with menses, no tampon use (Treatment A), | Drug | Cohort I |
| Dapivirine Vaginal Ring-004 with tamponsAlso: Treatment Bfollowed by Dapivirine Vaginal Ring-004 for 28 days, with menses, with tampon use (Treatment B) | Drug | Cohort I |
| Dapivirine Vaginal Ring-004 with no mensesAlso: Treatment EDapivirine Vaginal Ring-004 for 28 days, with no menses occurring (Treatment E; treatment period 3). | Drug | Cohort I, Cohort II |
| Dapivirine Vaginal Ring-004 and same ring inserted after mensesAlso: Treatment CDapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and the same ring re-inserted five days later (estimated completion of menses) (Treatment C) | Drug | Cohort II |
| Dapivirine Vaginal Ring-004 and new ring inserted after mensesAlso: Treatment DDapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and a new ring inserted five days later (estimated completion of menses) (Treatment D) | Drug | Cohort II |
Primary outcome
Dapivirine concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses, when no tampons are used, during a 28-day ring use period.
Time frame: 28 days
To determine the effect of menses on the local and systemic pharmacokinetics (PK) of dapivirine, delivered by the Dapivirine Vaginal Ring-004, in healthy, HIV-negative women
Dapivirine concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses, when tampons are used, during a 28-day ring use period.
Time frame: 28 days
To determine the effect of tampon use during menses on the local and systemic PK of dapivirine, delivered by the Dapivirine Vaginal Ring-004, in healthy, HIV-negative women.
4 secondary outcomes
Dapivirine concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses when the ring is removed at the onset of menses, and re-inserted after completion of menses for the remainder of a 28-day period.
Time frame: 28 days
Dapivirine concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses when the ring is removed at the onset of menses, and a new ring inserted after completion of menses
Time frame: 28 days
The residual amounts of dapivirine in used vaginal rings, removed at the onset of menses, where applicable, or on Day 28.
Time frame: 28 days
Safety will be assessed through the reporting of AEs, including SAEs, laboratory safety assessments (haematology, biochemistry, and urinalysis), physical and gynaecological examinations, and vaginal flora and pH assessments during the trial.
Time frame: 28 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 6 Sep 2017.
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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 Vaginal Ring-004 and no tampons, Dapivirine Vaginal Ring-004 with tampons and Dapivirine Vaginal Ring-004 with no menses in people with HIV, 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 15 inclusion and 16 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 6 Sep 2017. 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 concentrations in vaginal fluid and in plasma, measured at specified time points before, during, and after menses, when no tampons are used, during a 28-day ring use period. (time frame: 28 days). The study lists 2 primary outcomes in all. 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 6 Sep 2017.