Safety and Acceptability of a Non-Medicated Intravaginal Ring - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Microbicide Trials Network
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00672425

Purpose

There is an urgent need for HIV prevention methods that women can initiate and control themselves. Use of an intravaginal ring (IVR) to deliver microbicide products is a novel method for prevention of heterosexual transmission of HIV. The purpose of this study is to evaluate the safety and acceptability of a non-medicated IVR in HIV uninfected women.

Condition	Intervention	Phase
Healthy	Device: Intravaginal ring	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	Expanded Safety and Acceptability Study of a Non-Medicated Intravaginal Ring

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Acceptability of intravaginal ring [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Grade 2 or higher adverse event [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Frequency of intravaginal ring removal and duration of time without intravaginal ring inserted in vagina [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
Changes in vaginal flora as measured by Nugent score [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
Changes in quantitive vaginal culture. More information on this criterion can be found in the protocol. [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
Symptoms and signs suggestive of bacterial vaginosis or vulvovaginal candidiasis [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Changes in vaginal pH and vaginal wet mount microscopy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:

252

Arms	Assigned Interventions
A: Experimental 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.	Device: Intravaginal ring Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and stannous octoate. The ring will not contain an active pharmaceutical ingredient.
B: No Intervention Intravaginal ring will not be inserted into participants.

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 tolerability 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.

After screening, this study will consist of four study visits occuring at Weeks 4, 8, 12, and 16. Medical, menstrual, and medication history, a behavioral assessment, targeted physical exam, and pelvic exam will occur at all visits. Condoms will be provided and counseling will be available at each visit. A colposcopy will occur at least once and blood and urine collection will occur at some visits. An adherence and acceptability assessment will occur at all visits for participants in Group A. Participants in Group A will also receive IVR counseling.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

HIV uninfected
General good health
Normal menstrual cycle with at least 21 days between menses and no history of intermenstrual bleeding in the 3 months prior to study entry
Sexually active. More information on this criterion is available in the protocol.
Agree to use at least one effective methof of contraception. More information on this criterion can be found in the protocol.
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 or latex
Current male sex partner with known history of adverse reaction to silicone or latex
Gynecological procedure within 90 days prior to study entry. More information on this criterion can be found in the protocol.
Any abnormal physical or pelvic exam finding that, in the opinion of the investigator, would interfere with the study. More information on this criterion can be found in the protocol.
Social or medical condition that, in the opinion of the investigator, would interfere with the study
Current or anticipated participation in other drug or device research studies at enrollment and during the duration of study participation
Severe pelvic relaxation. More information on this criterion can be found in the protocol.
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672425

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Microbicide Trials Network

Investigators

Study Chair:

Craig Hoesley, MD

University of Alabama at Birmingham

More Information

Additional Information:

Click here for the Microbicide Trials Network Web site This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español This link exits the ClinicalTrials.gov site

Publications:

Gupta KM, Pearce SM, Poursaid AE, Aliyar HA, Tresco PA, Mitchnik MA, Kiser PF. Polyurethane intravaginal ring for controlled delivery of dapivirine, a nonnucleoside reverse transcriptase inhibitor of HIV-1. J Pharm Sci. 2008 Mar 13; [Epub ahead of print]

Woolfson AD, Malcolm RK, Morrow RJ, Toner CF, McCullagh SD. Intravaginal ring delivery of the reverse transcriptase inhibitor TMC 120 as an HIV microbicide. Int J Pharm. 2006 Nov 15;325(1-2):82-9. Epub 2006 Jun 23.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	MTN-005
Study First Received:	May 2, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00672425 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Safety and Acceptability

ClinicalTrials.gov processed this record on November 30, 2009