- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731574
DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate
September 5, 2017 updated by: International Partnership for Microbicides, Inc.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Antwerpen
-
Lange Beeldekensstraat 267, Antwerpen, Belgium, B-2060
- SGS Life Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dapivirine Ring + Miconazole
Dapivirine Ring + miconazole
|
|
Experimental: Dapivirine Ring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dapivirine Area under the concentration time curve (AUC)
Time Frame: 24 hr, 14 days, and 28 days
|
24 hr, 14 days, and 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
November 14, 2012
First Submitted That Met QC Criteria
November 19, 2012
First Posted (Estimate)
November 22, 2012
Study Record Updates
Last Update Posted (Actual)
September 8, 2017
Last Update Submitted That Met QC Criteria
September 5, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Dapivirine
- Miconazole
Other Study ID Numbers
- IPM 028
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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