CClinicalTrials.gg
CompletedNCT02847286Updated Aug 30, 2017

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 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

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Sep 2015, registered Jul 2016).
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • HIV- Prevention
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

Participants must meet all the following criteria to be eligible to enrol in the trial:

  1. Women 18 and ≤ 45 years of age who can give written informed consent
  2. Available for all visits and consent to follow all procedures scheduled for the trial
  3. 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
  4. HIV-negative as determined by an HIV test at the time of screening
  5. 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

Exclusion criteria

Exclusion Criteria:

Participants who have any of the following criteria are NOT eligible to enrol in the trial:

  1. Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
  2. Currently breast-feeding
  3. Currently or within 2 months of participation in any other clinical research trial involving investigational or marketed products prior to screening
  4. 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
  5. 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
  6. Current vulvar or vaginal symptoms/abnormalities that could influence the trial results
  7. Cervical cytology at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
  8. Symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection
  9. 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
  10. Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
  11. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone
  12. 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
  13. Have undergone a hysterectomy
  14. 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:

  15. Using a hormonal intrauterine device.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Treatment A

    Dapivirine Ring-004 for 28 days

    Drug: Dapivirine Ring-004

  • Active comparator
    Treatment B

    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

  • Active comparator
    Treatment C

    Clotrimazole, 5 g per day for 7 days

    Drug: Clotrimazole

Interventions

  • DrugDapivirine Ring-004

    Treatment A: Dapivirine Ring-004 for 28 days

    Also known as: Treatment A

  • DrugDapivirine Ring-004 for 28 days along with clotrimazole

    Treatment B: Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days

    Also known as: Treatment B

  • DrugClotrimazole

    Treatment C: Clotrimazole, 5 g per day for 7 days

    Also known as: Treatment C

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02847286
Lead sponsor
International Partnership for Microbicides, Inc.
Responsible party
Sponsor
First posted
Jul 28, 2016
Start date
Sep 1, 2015
Primary completion
Nov 28, 2016
Completion
Nov 28, 2016
Last update
Aug 30, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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