DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate
International Partnership for Microbicides, Inc.
Information provided by (Responsible Party)
International Partnership for Microbicides, Inc.
First received: November 14, 2012
Last updated: September 5, 2017
Last Verified: September 2017
History of Changes
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.
Drug : dapivirine
Drug : miconazole
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|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|
Further study details as provided by International Partnership for Microbicides, Inc.:
Primary Outcome Measures
- Dapivirine Area under the concentration time curve (AUC) [ Time Frame: 24 hr, 14 days, and 28 days ]
|Study Start Date:||December 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Dapivirine Ring + Miconazole
Dapivirine Ring + miconazole
|Ages Eligible for Study:||18 Years to 40 Years|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731574
Locations Show More
|SGS Life Sciences|
|Lange Beeldekensstraat 267, Antwerpen, Belgium, B-2060|
Sponsors and CollaboratorsInternational Partnership for Microbicides, Inc.
|Responsible Party:||International Partnership for Microbicides, Inc.|
|ClinicalTrials.gov Identifier:||NCT01731574 History of Changes|
|Other Study ID Numbers:||IPM 028|
|Study First Received:||November 14, 2012|
|Last Updated:||September 5, 2017|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.