A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

International Partnership for Microbicides, Inc.7 sites in 2 countries1,959 target enrollmentMarch 27, 2012

ConditionsHIV Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infections
Sponsor: International Partnership for Microbicides, Inc.
Enrollment: 1959
Locations: 7
Primary Endpoint: HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Detailed Description

A multi center, randomized, double-blind, placebo=controlled safety and efficacy trial of a Dapivirine Vaginal Matrix Ring in healthy HIV-negative women.

Registry

clinicaltrials.gov

Start Date

March 27, 2012

End Date

December 13, 2016

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

International Partnership for Microbicides, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women \> 18 and \< 45 years of age, at screening, who can provide informed consent;
•Available for all visits and consent to follow all procedures scheduled for the trial;
•Self-reported sexually active (defined as an average of at least one penetrative penile-vaginal coital act per month for the last 3 months prior to screening);
•HIV-negative as determined by the HIV algorithm applied at screening and enrolment;
•On a stable form of contraception as defined within section 5.4 and willing to continue on stable contraception for the duration of the clinical trial, unless post-menopausal or surgically sterilised;
•Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any clinically significant curable STI, she must have initiated treatment at least 1 week prior to enrolment and have completed the full course of treatment);
•Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures (e.g., by home visit or telephone; or via family or close neighbour contacts); confidentiality to be maintained;
•Willing to refrain from participation in another research trial using drugs, vaccines, medical devices, microbicides or oral pre-exposure prophylaxis investigational drugs for the duration of the IPM 027 trial.

Exclusion Criteria

•Currently pregnant or last pregnancy within 3 months prior to screening or intends to become pregnant during trial participation;
•Currently breast-feeding;
•Non-therapeutic injection drug use in the 12 months prior to screening;
•Participated in another research trial using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 60 days prior to screening;
•Previously participated or currently participating in any HIV vaccine trial;
•Untreated, clinically significant urogenital infections , e.g., urinary tract, or other sexually transmitted infections, or other gynaecological symptoms within 1 week prior to enrolment;
•Has a Grade 2 or higher pelvic examination finding, according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies;
•History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, diagnosed chronic and/or recurrent vulvovaginal candidiasis, urethral obstruction, incontinence or urge incontinence;
•Any gynaecological surgery within 90 days prior to screening;
•Any Grade 1 or higher baseline aspartate aminotransferase (AST), alanine transaminase (ALT), or platelet count, and any Grade 2 or higher baseline haematology, chemistry or urinalysis laboratory value according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;

Outcomes

Primary Outcomes

HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm.

Time Frame: 24 months

HIV-1 seroconversion measured by rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm.

All Adverse Events

Time Frame: 24 months

Self-reports, physical examination, gynaecological assessments, including pelvic/speculum examination, laboratory tests and other indicated investigations. All AEs will be reported, regardless of grade or relatedness.

Secondary Outcomes

The Incidence Rate of HIV-2 Seroconversion.(24 months)
The Incidence of Curable STIs(24 months)
Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period;(24 months)
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;(24 months)
The Percentage of Women Who Report the Use of the Vaginal Ring as Acceptable;(24 months)
The Percentage of Participants With HIV-1 Drug Resistance Mutations Among Participants Who Acquire HIV-1.(24 months)