Expanded Use PK of Dapivirine Vaginal Ring

NCT01952561 | Completed Phase 1

• 1 other identifier: IPM 034
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pharmacokinetics

Keywords

pharmacokinetics; vaginal ring

Outcome Measures

Primary Outcomes (1)

• dapivirine pharmacokinetics in plasma

  1,2,4,8 or 12 weeks

Study Arms (5)

2 weeks

EXPERIMENTAL

Drug: dapivirine ring

1 week

EXPERIMENTAL

Drug: dapivirine ring

4 weeks

EXPERIMENTAL

Drug: dapivirine ring

8 weeks

EXPERIMENTAL

Drug: dapivirine ring

12 weeks

EXPERIMENTAL

Drug: dapivirine ring

Interventions

dapivirine ring DRUG

1 week; 12 weeks; 2 weeks; 4 weeks; 8 weeks

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 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, laboratory evaluations for genital infections, 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 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
• Willing to refrain from the use of topical vaginal medications, vaginal products or objects
• 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

You may not qualify if:

• 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;
• 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;
• 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 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.

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 30, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 26, 2016

Record last verified: 2013-09