A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method

This study is currently recruiting participants.

Verified by International Partnership for Microbicides, Inc., August 2009

First Received: May 3, 2007 Last Updated: August 31, 2009 History of Changes

Sponsor:	International Partnership for Microbicides, Inc.
Information provided by:	International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:	NCT00469170

Purpose

The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.

Condition	Intervention	Phase
HIV Infections	Device: intravaginal ring	Phase 0

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety Study
Official Title:	A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:

The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental vaginal ring first 12 weeks & observational safety last 12 weeks	Device: intravaginal ring silicone elastomer intravaginal ring containing no drug product
B: Experimental observational safety first 12 weeks & vaginal ring last 12 weeks	Device: intravaginal ring silicone elastomer intravaginal ring containing no drug product

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female, age 18-35 years
Willing and able to provide written informed consent
HIV-uninfected and otherwise healthy
Self-reported sexually active
On a stable hormonal contraceptive regimen
Regular menstrual cycle
Willing to refrain from use of vaginal products or objects during the study

Exclusion Criteria:

Currently pregnant or last pregnancy within 3 months prior to enrollment
Currently breast-feeding
Participated in any other research study within 30 days prior to enrollment;
Symptomatic untreated vaginal infections within 2 weeks prior to enrollment
Presence of abnormal physical finding on the vulva, vaginal walls or cervix
History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction;
Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
Any serious acute, chronic or progressive disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469170

Contacts

Contact: Karen Douville

301-608-2221

kdouville@ipm-microbicides.org

Locations

Kenya
International Centre for Reproductive Health	Withdrawn
Mombasa, Kenya
South Africa
Desmond Tutu HIV Foundation, Masiphumelele	Recruiting
Cape Town, South Africa, 7975
Contact: Prof. Linda-Gail Bekker linda-gail.bekker@hiv-research.org.za
Principal Investigator: Dr. Linda-Gail Bekker
Sub-Investigator: Dr. Jennifer Pitt
South Africa, Johannesburg
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic	Completed
Yeoville, Johannesburg, South Africa
South Africa, KwaZulu Natal
South African Medical Research Council	Completed
Durban, KwaZulu Natal, South Africa, 4067
Tanzania
Kilimanjaro Reproductive Health Program	Completed
Moshi, Tanzania

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director:

Dr. Annalene Nel

IPM

More Information

No publications provided

Responsible Party:	International Partnership for Microbicides ( Zeda Rosenberg ScD )
Study ID Numbers:	IPM 011
Study First Received:	May 3, 2007
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00469170 History of Changes
Health Authority:	South Africa: Medicines Control Council; Kenya: Ministry of Health; Tanzania: Food & Drug Administration

Keywords provided by International Partnership for Microbicides, Inc.:

HIV-1
HIV seronegativity

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 30, 2009