A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women

International Partnership for Microbicides, Inc.4 sites in 2 countries220 target enrollmentMarch 2007

ConditionsHIV Infections

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: HIV Infections
Sponsor: International Partnership for Microbicides, Inc.
Enrollment: 220
Locations: 4
Primary Endpoint: The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

February 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

International Partnership for Microbicides, Inc.

Eligibility Criteria

Inclusion Criteria

•Female, age 18-35 years
•Willing and able to provide written informed consent
•HIV-uninfected and otherwise healthy
•Self-reported sexually active
•On a stable hormonal contraceptive regimen
•Regular menstrual cycle
•Willing to refrain from use of vaginal products or objects during the study

Exclusion Criteria

•Currently pregnant or last pregnancy within 3 months prior to enrollment
•Currently breast-feeding
•Participated in any other research study within 30 days prior to enrollment;
•Symptomatic untreated vaginal infections within 2 weeks prior to enrollment
•Presence of abnormal physical finding on the vulva, vaginal walls or cervix
•History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction;
•Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
•Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
•Any serious acute, chronic or progressive disease

Outcomes

Primary Outcomes

The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV.

Time Frame: 3 months

The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events

Time Frame: 3 months