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Completed

NCT Number: NCT01268332

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

National AIDS Research Institute, Pune, India

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-medicated Intravaginal Ring

Drug

Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.

Other names: Placebo Intravaginal Ring

Primary outcomes

  1. Adherence to intravaginal ring

    Time frame: Throughout study

  2. Grade 2 or higher adverse event

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Population Council

Other

Collaborators

  • Microbicide Trials Network
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Expanded Safety and Adherence Study of a Non-medicated Intravaginal Ring

Acronym: MTN-005

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Dec 30, 2010
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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