A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
This study has been completed.
Sponsor:
International Partnership for Microbicides, Inc.
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00469170
First received: May 3, 2007
Last updated: November 10, 2010
Last verified: November 2010
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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
|
![](https://webarchive.library.unt.edu/web/20130317081502im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
![](https://webarchive.library.unt.edu/web/20130317081502im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
![](https://webarchive.library.unt.edu/web/20130317081502im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 March 14, 2013