A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method - Full Text View

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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/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 ]

Enrollment:	220
Study Start Date:	March 2007
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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

Locations

South Africa
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg, South Africa
South African Medical Research Council
Durban, KwaZulu Natal, South Africa, 4067
Desmond Tutu HIV Foundation, Masiphumelele
Cape Town, South Africa, 7975
Tanzania
Kilimanjaro Reproductive Health Program
Moshi, Tanzania

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director:

Dr. Annalene Nel

IPM

More Information

No publications provided

Responsible Party:	Annalene Nel, International Partnership for Microbicides
ClinicalTrials.gov Identifier:	NCT00469170 History of Changes
Other Study ID Numbers:	IPM 011
Study First Received:	May 3, 2007
Last Updated:	November 10, 2010
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012