Expanded Use PK of Dapivirine Vaginal Ring

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by International Partnership for Microbicides, Inc.
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01952561
First received: September 17, 2013
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.


Condition Intervention Phase
Pharmacokinetics
Drug: dapivirine ring
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-label, Parallel-group Pharmacokinetic Trial in Healthy HIV-negative Women to Characterize the Release Profile of Dapivirine Delivered by a Silicone Matrix Ring (Ring 004), Containing 25 mg of Dapivirine, Over Various Ring Use Periods

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • dapivirine pharmacokinetics in plasma [ Time Frame: 1,2,4,8 or 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 weeks Drug: dapivirine ring
Experimental: 1 week Drug: dapivirine ring
Experimental: 4 weeks Drug: dapivirine ring
Experimental: 8 weeks Drug: dapivirine ring
Experimental: 12 weeks Drug: dapivirine ring

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Women 18 and ≤ 40 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, laboratory evaluations for genital infections, and laboratory evaluations for haematology and chemistry
  4. HIV-negative as determined by an HIV test at the time of enrolment
  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 IUD inserted 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
  7. Asymptomatic for genital infections at the time of enrolment
  8. Willing to refrain from the use of topical vaginal medications, vaginal products or objects
  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
  12. 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
  13. Hepatitis B and C negative at the time of enrolment.

Key Exclusion Criteria:

  1. Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
  2. Currently breast-feeding
  3. Currently or within two 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 sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment
  5. Have a Grade 2 or higher pelvic examination finding, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;
  6. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence
  7. Current vulvar or vaginal symptoms/abnormalities that could influence the trial results
  8. Cervical cytology at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
  9. Symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection
  10. 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;
  11. Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
  12. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone
  13. Any serious acute, chronic or progressive or signs of cardiac disease, renal failure, or severe malnutrition
  14. Have undergone a hysterectomy
  15. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
  Contacts and Locations
Choosing 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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01952561     History of Changes
Other Study ID Numbers: IPM 034
Study First Received: September 17, 2013
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Health Authority

Keywords provided by International Partnership for Microbicides, Inc.:
pharmacokinetics
vaginal ring

ClinicalTrials.gov processed this record on July 29, 2014