Healthy
Conditions
Keywords
Placebo IVR as a delivery method
Brief summary
The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR in HIV uninfected women over 12 weeks of use.
Detailed description
Women comprise a growing proportion of new HIV infections worldwide. Intravaginal rings (IVRs) used to deliver microbicides have the potential to significantly reduce the heterosexual transmission of HIV if found to be safe, acceptable, and effective against HIV infection. This study will investigate the safety and acceptability of a non-medicated silicone elastomer IVR in sexually active HIV uninfected women. The expected duration of this study for each participant is 16 weeks. Study participants will be randomly assigned to one of two arms. Participants in Group A will insert an IVR into their vagina at study entry. The IVR will remain in place for 12 weeks until removed by a physician. Follow up will continue for an additional 4 weeks after IVR removal. Participants in Group B will not receive an IVR, but will follow the same study schedule as those in Group A.
Interventions
DRUGNon-medicated Intravaginal Ring
Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Microbicide Trials Network
Population Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* HIV uninfected * General good health * Sexually active * Agree to use an effective method of contraception * Normal Pap smear result within 12 months prior to study entry * Agree to not participate in other drug or device research studies for the duration of study participation * Agree to not use any intravaginal product for the duration of study participation
Exclusion criteria
* History of adverse reaction to silicone, latex, or titanium dioxide * Current male sex partner with known history of adverse reaction to silicone, latex, or titanium dioxide * Last pregnancy outcome within 30 days or less prior to enrollment * History of hysterectomy * Any abnormal pelvic exam finding * Pregnant * Condition that, in the opinion of the investigator, would interfere with the study * Severe pelvic relaxation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to intravaginal ring | Throughout study |
| Grade 2 or higher adverse event | Throughout study |
Countries
India, United States
Outcome results
None listed