A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.

International Partnership for Microbicides, Inc.10 sites in 4 countries280 target enrollmentApril 2010

ConditionsHIV Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HIV Infections
Sponsor: International Partnership for Microbicides, Inc.
Enrollment: 280
Locations: 10
Primary Endpoint: Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

July 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

International Partnership for Microbicides, Inc.

Eligibility Criteria

Inclusion Criteria

•Women between 18 and 40 years of age inclusive who can provide informed consent
•Available for all visits and consent to follow all procedures scheduled for the study
•Healthy and self-reported sexually active
•HIV-negative
•On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment
•In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses
•Upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator
•Asymptomatic for genital infections at the time of enrolment
•Willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study
•Willing to answer to acceptability, adherence and behavioural assessments throughout the study

Exclusion Criteria

•Currently pregnant or last pregnancy within 3 months prior to enrolment
•Currently breast-feeding
•Participated in any other research study within 60 days prior to screening
•Previously participated in any HIV vaccine study
•Untreated urogenital infections within 2 weeks prior to enrolment
•Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
•History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction, incontinence or urge incontinence
•Pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation
•Any Grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Events
•Any abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment

Outcomes

Primary Outcomes

Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study.

Time Frame: 16 weeks

Secondary Outcomes

Acceptability of the product determined by questionnaire.(16 weeks)
Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.(12 weeks)