HIV- PreventionPhase 1NCT02847286
To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)
A Phase 1 study testing Dapivirine Ring-004, Dapivirine Ring-004 for 28 days along with clotrimazole and Clotrimazole in people with HIV- Prevention, run by International Partnership for Microbicides, Inc..
Trial summary
A Study to assess the drug-drug interaction potential, between 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- Prevention
- What is being tested?
- Dapivirine Ring-004, Dapivirine Ring-004 for 28 days along with clotrimazole and Clotrimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 28 Nov 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 enrol in the trial:
- Women 18 and ≤ 45 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), laboratory evaluations for genital infections (bacterial vaginosis, gonorrhoea, chlamydia and trichomonas), and laboratory evaluations for haematology and chemistry
- HIV-negative as determined by an HIV test at the time of screening
- On a stable form of contraception, defined as:
- A stable oral contraceptive regimen for at least 2 months prior to enrolment, OR 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 intra-uterine device (IUD) inserted (with no vaginal or gynaecological complaints associated with its use) 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 6. 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 (if a woman is diagnosed with any treatable STI, either clinically or by laboratory test at the time of screening, she must complete treatment prior to enrolment) 8. Willing to refrain from the use of topical vaginal medications, vaginal products or objects, including female condoms, tampons, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, and drying agents for 14 days prior to enrolment and for the duration of the trial 9. Documentation of no abnormality on cervical cytology, including grossly bloody smear, within 90 days prior to screening 10. Willing to refrain from participation in any other research trial for the duration of this trial 11. 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 (confidentiality to be maintained) 12. Willing to agree to abstain for a total of 2 days (48 hours) prior to each trial visit from: Penile-vaginal intercourse Oral contact with her genitalia 13. Hepatitis B and C negative at the time of screening
Who cannot join
- Participants who have any of the following criteria are NOT eligible to enrol in the trial:
- Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
- Currently breast-feeding
- Currently or within 2 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 14 days prior to enrolment
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence, urge incontinence or an anatomical variation that will not allow placement or retention of the ring
Show all 17Show fewer
- 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 Division of Acquired Immunodeficiency Syndrome (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 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 disease (e.g. any known history of neoplasm, cancer, diabetes, epilepsy, cardiac disease, autoimmune disease, HIV, Acquired Immunodeficiency Syndrome [AIDS], or blood dyscrasias), 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.
- Participants who have the following criterion are NOT eligible for Treatment F:
- Using a hormonal intrauterine device.
About this study
Official title: AN OPEN-LABEL, RANDOMISED TRIAL, WITH A THREE-PERIOD CROSSOVER PART IN HEALTHY HIV-NEGATIVE WOMEN TO ASSESS THE DRUG-DRUG INTERACTION POTENTIAL BETWEEN DAPIVIRINE VAGINAL RING-004, CONTAINING 25 MG OF DAPIVIRINE, AND CLOTRIMAZOLE 10 mg/g (1%) ADMINISTERED AS A VAGINAL CREAM, WITH A FOLLOW-ON PERIOD TO ASSESS THE EFFECT OF MULTIPLE RING REMOVALS AND RE-INSERTIONS DURING THE 28-DAY PERIOD OF THE DAPIVIRINE VAGINAL RING-004 USE ON THE SYSTEMIC AND LOCAL EXPOSURE AND RESIDUAL AMOUNT OF DAPIVIRINE IN USED RINGS
A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004, containing 25 MG of Dapivirine.
Read the detailed description
AN OPEN-LABEL, RANDOMISED TRIAL, WITH A THREE-PERIOD CROSSOVER PART IN HEALTHY HIV-NEGATIVE WOMEN TO ASSESS THE DRUG-DRUG INTERACTION POTENTIAL BETWEEN DAPIVIRINE VAGINAL RING-004, CONTAINING 25 MG OF DAPIVIRINE, AND CLOTRIMAZOLE 10 mg/g (1%) ADMINISTERED AS A VAGINAL CREAM, WITH A FOLLOW-ON PERIOD TO ASSESS THE EFFECT OF MULTIPLE RING REMOVALS AND RE-INSERTIONS DURING THE 28-DAY PERIOD OF THE DAPIVIRINE VAGINAL RING-004 USE ON THE SYSTEMIC AND LOCAL EXPOSURE AND RESIDUAL AMOUNT OF DAPIVIRINE IN USED RINGS
- Conditions
- HIV- Prevention
- Being tested
- Dapivirine Ring-004, Dapivirine Ring-004 for 28 days along with clotrimazole, Clotrimazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapivirine Ring-004Drug
Also called Treatment A
Treatment A: Dapivirine Ring-004 for 28 days
Dapivirine Ring-004 for 28 days along with clotrimazoleDrug
Also called Treatment B
Treatment B: Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days
ClotrimazoleDrug
Also called Treatment C
Treatment C: Clotrimazole, 5 g per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Dapivirine Ring-004 for 28 days Receives: Drug: Dapivirine Ring-004 |
| Treatment B | Active comparator | Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days Receives: Drug: Dapivirine Ring-004 for 28 days along with clotrimazole |
| Treatment C | Active comparator | Clotrimazole, 5 g per day for 7 days Receives: Drug: Clotrimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dapivirine concentrations in plasma
Dapivirine concentrations in plasma, measured at specified time points during each 28-day period that the ring is inserted, and for 14 days following ring removal
Measured: 28-day
Clotrimazole concentrations in plasma
Clotrimazole concentrations in plasma, measured at specified time points during 7 days of once daily dosing, and for 14 days after the last administration.
Measured: 7 days of once daily dosing, and for 14 days after the last administration
Secondary outcomes (2)
Dapivirine concentrations in vaginal fluid
Dapivirine concentrations in vaginal fluid, collected at the cervix, measured at specified time points during each 28-day period that the ring is inserted, and for three days following ring removal.
Measured: 28 days
Clotrimazole concentrations in vaginal fluid
Clotrimazole concentrations in vaginal fluid, measured at specified time points during 7 days of once daily dosing, and following 14 days after the last administration.
Measured: 7 days of once daily dosing, and following 14 days after the last administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start1 Sep 2015
- Primary completion28 Nov 2016
- Study completion28 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV- PreventionStudies 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
- 36 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
- NCT02847286
- Sponsor's protocol ID
- IPM 036
- Status last verified
- Aug 2017
- First submitted
- 25 Jul 2016
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL, RANDOMISED TRIAL, WITH A THREE-PERIOD CROSSOVER PART IN HEALTHY HIV-NEGATIVE WOMEN TO ASSESS THE DRUG-DRUG INTERACTION POTENTIAL BETWEEN DAPIVIRINE VAGINAL RING-004, CONTAINING 25 MG OF DAPIVIRINE, AND CLOTRIMAZOLE 10 mg/g (1%) ADMINISTERED AS A VAGINAL CREAM, WITH A FOLLOW-ON PERIOD TO ASSESS THE EFFECT OF MULTIPLE RING REMOVALS AND RE-INSERTIONS DURING THE 28-DAY PERIOD OF THE DAPIVIRINE VAGINAL RING-004 USE ON THE SYSTEMIC AND LOCAL EXPOSURE AND RESIDUAL AMOUNT OF DAPIVIRINE IN USED RINGS
- ClinicalTrials.gov ID
- NCT02847286
- Acronym / sponsor ID
- IPM 036
- Conditions
- HIV- Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 28 Jul 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 Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004, containing 25 MG of Dapivirine.
Detailed description
AN OPEN-LABEL, RANDOMISED TRIAL, WITH A THREE-PERIOD CROSSOVER PART IN HEALTHY HIV-NEGATIVE WOMEN TO ASSESS THE DRUG-DRUG INTERACTION POTENTIAL BETWEEN DAPIVIRINE VAGINAL RING-004, CONTAINING 25 MG OF DAPIVIRINE, AND CLOTRIMAZOLE 10 mg/g (1%) ADMINISTERED AS A VAGINAL CREAM, WITH A FOLLOW-ON PERIOD TO ASSESS THE EFFECT OF MULTIPLE RING REMOVALS AND RE-INSERTIONS DURING THE 28-DAY PERIOD OF THE DAPIVIRINE VAGINAL RING-004 USE ON THE SYSTEMIC AND LOCAL EXPOSURE AND RESIDUAL AMOUNT OF DAPIVIRINE IN USED RINGS
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Dapivirine Ring-004Dapivirine Ring-004 for 28 days |
| Treatment B | Active comparator | Drug: Dapivirine Ring-004 for 28 days along with clotrimazoleDapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days |
| Treatment C | Active comparator | Drug: ClotrimazoleClotrimazole, 5 g per day for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women 18 and ≤ 45 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), laboratory evaluations for genital infections (bacterial vaginosis, gonorrhoea, chlamydia and trichomonas), and laboratory evaluations for haematology and chemistry
- HIV-negative as determined by an HIV test at the time of screening
- On a stable form of contraception, defined as:
Key exclusion criteria (17 listed)
- Participants who have any of the following criteria are NOT eligible to enrol in the trial:
- Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
- Currently breast-feeding
- Currently or within 2 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 14 days prior to enrolment
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-004Also: Treatment ATreatment A: Dapivirine Ring-004 for 28 days | Drug | Treatment A |
| Dapivirine Ring-004 for 28 days along with clotrimazoleAlso: Treatment BTreatment B: Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days | Drug | Treatment B |
| ClotrimazoleAlso: Treatment CTreatment C: Clotrimazole, 5 g per day for 7 days | Drug | Treatment C |
Primary outcome
Dapivirine concentrations in plasma
Time frame: 28-day
Dapivirine concentrations in plasma, measured at specified time points during each 28-day period that the ring is inserted, and for 14 days following ring removal
Clotrimazole concentrations in plasma
Time frame: 7 days of once daily dosing, and for 14 days after the last administration
Clotrimazole concentrations in plasma, measured at specified time points during 7 days of once daily dosing, and for 14 days after the last administration.
2 secondary outcomes
Dapivirine concentrations in vaginal fluid
Time frame: 28 days
Clotrimazole concentrations in vaginal fluid
Time frame: 7 days of once daily dosing, and following 14 days after the last administration.
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 30 Aug 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapivirine Ring-004, Dapivirine Ring-004 for 28 days along with clotrimazole and Clotrimazole in people with HIV- Prevention, 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 7 inclusion and 17 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 30 Aug 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 plasma (time frame: 28-day). 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 30 Aug 2017.