A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469768
• Other study ID #: IPM 018
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2007
• Last updated: August 31, 2009
• Start date: May 2007
• Est. completion date: August 2007

Study information

• Verified date: August 2009
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• dapivirine reservoir intravaginal ring
a silicone elastomer reservoir ring containing 25mg of dapivirine
• dapivirine matrix intravaginal ring
a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine

Other:
• placebo intravaginal ring
a silicone elastomer intravaginal ring containing no dapivirine

Locations

Country	Name	City	State
Belgium	Drug Research Unit Ghent (D.R.U.G.)	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Country where clinical trial is conducted

Belgium, 

External Links

•   Drug Research Unit Ghent website