Safety and Adherence of a Non-medicated Intravaginal Ring (IVR) (MTN-005)

Population Council

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Non-medicated Intravaginal Ring

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT01268332

Population Council #508

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

Intravaginal Ring

Experimental group

Description:

Insertion of intravaginal ring at enrollment. The intravaginal ring should stay in place for 12 consecutive weeks and will be removed by a physician at the Week 12 study visit.

Treatment:

Drug: Non-medicated Intravaginal Ring

No Intravaginal Ring

No Intervention group

Description:

Intravaginal ring will not be inserted into participants.