HIV Infections
Conditions
Keywords
HIV-1, HIV seronegativity
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.
Interventions
DEVICEintravaginal ring
silicone elastomer intravaginal ring containing no drug product
Sponsors
International Partnership for Microbicides, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 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 | 3 months |
Countries
South Africa, Tanzania
Outcome results
None listed