A Safety Study of Dapivirine Vaginal Ring in Africa

International Partnership for Microbicides (IPM)

Status and phase

Completed

Phase 2

Phase 1

Conditions

HIV Infections

Treatments

Other: Placebo

Other: Dapivirine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01071174

IPM 015

Details and patient eligibility

About

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.

Enrollment

280 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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
Willing to refrain from participation in any other research study for the duration of their participation
Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures

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
Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone elastomer
Any serious acute, chronic or progressive disease
Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives