Clinical trial NCT01268332: Safety and Adherence of a Non-medicated Intravaginal Ring (IVR)
Official title: Expanded Safety and Adherence Study of a Non-medicated Intravaginal Ring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Placebo IVR as a delivery method
Lead sponsor: Population Council
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute of Mental Health (NIMH)
name: Microbicide Trials Network
First posted: 2010-12-30
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to intravaginal ring
timeFrame: Throughout study
measure: Grade 2 or higher adverse event
timeFrame: Throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: The Bronx
country: United States
facility: Bronx-Lebanon Hospital Center
state: New York
city: Pune
country: India
facility: National AIDS Research Institute
Study officials:
affiliation: University of Alabama at Birmingham
name: Craig Hoesley, MD
role: STUDY_CHAIR
References: