A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 3, 2007

Last Updated Date

September 25, 2007

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00469768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

Official Title ^†

A Double-Blind, Randomized, Placebo-Controlled Safety and Pharmacokinetic Study in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From Matrix and Reservoir Intravaginal Rings Each Containing 25 mg of Dapivirine

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

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study

Condition ^†

HIV Infections

Intervention ^†

Drug: dapivirine reservoir intravaginal ring
Drug: dapivirine matrix intravaginal ring
Other: placebo intravaginal ring

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

August 2007

Primary Completion Date

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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Belgium

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00469768

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

International Partnership for Microbicides, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Dr. Annalene Nel

International Partnership for Microbicides (IPM)

Information Provided By

International Partnership for Microbicides, Inc.

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.