A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium - Full Text View

Sponsored by:	International Partnership for Microbicides, Inc.
Information provided by:	International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:	NCT00469768

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: dapivirine reservoir intravaginal ring Drug: dapivirine matrix intravaginal ring Other: placebo intravaginal ring	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Dapivirine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study
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

Further study details as provided by International Partnership for Microbicides, Inc.:

Enrollment:	24
Study Start Date:	May 2007
Study Completion Date:	August 2007

Arms	Assigned Interventions
A: Experimental	Drug: dapivirine matrix intravaginal ring a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
B: Experimental	Drug: dapivirine reservoir intravaginal ring a silicone elastomer reservoir ring containing 25mg of dapivirine
C: Placebo Comparator	Other: placebo intravaginal ring a silicone elastomer intravaginal ring containing no dapivirine

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469768

Locations

Belgium
Drug Research Unit Ghent (D.R.U.G.)
Ghent, Belgium, 9000

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director:

Dr. Annalene Nel

International Partnership for Microbicides (IPM)

More Information

Additional Information:

Drug Research Unit Ghent website This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	IPM 018
Study First Received:	May 3, 2007
Last Updated:	September 25, 2007
ClinicalTrials.gov Identifier:	NCT00469768 History of Changes
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by International Partnership for Microbicides, Inc.:

HIV-1 infection
HIV Seronegativity

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 06, 2009