HIVPhase 1NCT01731574
DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate
A Phase 1 study testing dapivirine and miconazole in people with HIV, run by International Partnership for Microbicides, Inc. at 1 site in Belgium.
Trial summary
This trial will investigate the potential drug-drug interaction between dapivirine vaginal Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy, HIV-negative women. 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
- HIV
- What is being tested?
- dapivirine and miconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2012to Oct 2013
- 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 between 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 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 (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
- 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 receive treatment at least 2 weeks prior to enrolment)
- Willing to refrain from the use of topical 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.
- 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 (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 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; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies
- 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; 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, 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Three-period Crossover Trial in Healthy HIV-negative Women to Assess the Drug-drug Interaction Between Dapivirine Vaginal Ring-004 and Miconazole Nitrate
This trial will investigate the potential drug-drug interaction between dapivirine vaginal Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy, HIV-negative women.
- Conditions
- HIV
- Being tested
- dapivirine, miconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapivirineDrug
miconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine Ring + Miconazole | Active comparator | Dapivirine Ring + miconazole Receives: Drug: dapivirine; Drug: miconazole |
| Dapivirine Ring | Experimental | Dapivirine Ring Receives: Drug: dapivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dapivirine Area under the concentration time curve (AUC)
Measured: 24 hr, 14 days, and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2013
- Study completionOct 2013
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
- 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
- NCT01731574
- Sponsor's protocol ID
- IPM 028
- Status last verified
- Sep 2017
- First submitted
- 14 Nov 2012
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Three-period Crossover Trial in Healthy HIV-negative Women to Assess the Drug-drug Interaction Between Dapivirine Vaginal Ring-004 and Miconazole Nitrate
- ClinicalTrials.gov ID
- NCT01731574
- Acronym / sponsor ID
- IPM 028
- Conditions
- HIV
- 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
- Dec 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Nov 2012 (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.
This trial will investigate the potential drug-drug interaction between dapivirine vaginal Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy, HIV-negative women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapivirine Ring + Miconazole | Active comparator | Drug: dapivirine, Drug: miconazoleDapivirine Ring + miconazole |
| Dapivirine Ring | Experimental | Drug: dapivirineDapivirine Ring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Women between 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 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; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies
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 | Drug | Dapivirine Ring, Dapivirine Ring + Miconazole |
| miconazole | Drug | Dapivirine Ring + Miconazole |
Primary outcome
Dapivirine Area under the concentration time curve (AUC)
Time frame: 24 hr, 14 days, and 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 8 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.
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 and miconazole in people with HIV, run by International Partnership for Microbicides, Inc. at 1 site in Belgium.
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 8 Sep 2017. 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 Belgium. 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?
Dapivirine Area under the concentration time curve (AUC) (time frame: 24 hr, 14 days, and 28 days). 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 8 Sep 2017.