A Phase 1 interventional study of Dapivirine Ring-004 and Dapivirine Ring-004 for 28 days along with clotrimazole in HIV- Prevention, sponsored by International Partnership for Microbicides, Inc.. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by International Partnership for Microbicides, Inc. · Phase 1, Interventional, and Prevention
A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004, containing 25 MG of Dapivirine.
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
International Partnership for Microbicides, Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 5 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must meet all the following criteria to be eligible to enrol in the trial:
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
Exclusion Criteria:
Participants who have any of the following criteria are NOT eligible to enrol in the trial:
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:
Dapivirine Ring-004 for 28 days
Drug: Dapivirine Ring-004
Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days
Drug: Dapivirine Ring-004 for 28 days along with clotrimazole
Clotrimazole, 5 g per day for 7 days
Drug: Clotrimazole
Treatment A: Dapivirine Ring-004 for 28 days
Also known as: Treatment A
Treatment B: Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days
Also known as: Treatment B
Treatment C: Clotrimazole, 5 g per day for 7 days
Also known as: Treatment C
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
Time frame: 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.
Time frame: 7 days of once daily dosing, and for 14 days after the last administration
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.
Time frame: 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.
Time frame: 7 days of once daily dosing, and following 14 days after the last administration.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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International Partnership for Microbicides, Inc.