A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

International Partnership for Microbicides (IPM)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: dapivirine reservoir intravaginal ring

Other: placebo intravaginal ring

Drug: dapivirine matrix intravaginal ring

Study type

Interventional

Funder types

Industry

Identifiers

NCT00469768

IPM 018

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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