A Pharmacokinetic Study of Dapivirine Vaginal Rings in Be... | NCT00469768

Studies
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

NCT00469768

Sponsor

International Partnership for Microbicides, Inc.

Status

Completed

Last Update Posted

Sep 1, 2009Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

HIV Infections

Interventions

dapivirine reservoir intravaginal ring
dapivirine matrix intravaginal ring
placebo intravaginal ring

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

May 3, 2007

First Submission Date that Met QC Criteria

May 3, 2007

First Posted Date

May 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2009

Last Update Posted Date

Sep 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A	Experimental	Drug: dapivirine matrix intravaginal ring
B	Experimental	Drug: dapivirine reservoir intravaginal ring
C	Placebo Comparator	Other: placebo intravaginal ring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dapivirine reservoir intravaginal ring	Drug	a silicone elastomer reservoir ring containing 25mg of dapivirine	B

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral