A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

NCT ID: NCT00469768

Last Updated: 2009-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2007-08-31

Brief Summary

IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

A

Group Type: EXPERIMENTAL

dapivirine matrix intravaginal ring

Intervention Type: DRUG

a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine

B

Group Type: EXPERIMENTAL

dapivirine reservoir intravaginal ring

Intervention Type: DRUG

a silicone elastomer reservoir ring containing 25mg of dapivirine

C

Group Type: PLACEBO_COMPARATOR

placebo intravaginal ring

Intervention Type: OTHER

a silicone elastomer intravaginal ring containing no dapivirine

Interventions

dapivirine reservoir intravaginal ring

a silicone elastomer reservoir ring containing 25mg of dapivirine

Intervention Type: DRUG

dapivirine matrix intravaginal ring

a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine

Intervention Type: DRUG

placebo intravaginal ring

a silicone elastomer intravaginal ring containing no dapivirine

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women between 18 and 35 years of age
• Willing and able to give written informed consent
• Available for all visits and consent to follow all procedures scheduled for the study
• Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment;
• Willing to abstain from sexual activity for the duration of the study
• Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment
• Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal
• Willing to refrain from use of vaginal products or objects for the duration of the study.

Exclusion Criteria

• History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements;
• History of sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer)
• Currently pregnant or breast-feeding, or within three months of last pregnancy outcome
• Currently or within one month of participating in any other clinical research study
• History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months
• History of genital tract surgery within the last month
• Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas)
• Current vulvar or vaginal symptoms / abnormalities that could influence the study results
• History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months;
• Smoking more than 10 cigarettes per day

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

International Partnership for Microbicides

Principal Investigators

Dr. Annalene Nel

Role: STUDY_DIRECTOR

International Partnership for Microbicides (IPM)

Locations

Drug Research Unit Ghent (D.R.U.G.)

Ghent, , Belgium

Countries

Belgium

Other Identifiers

IPM 018

Identifier Type: -

Identifier Source: org_study_id