| May 3, 2007 |
| August 31, 2009 |
| March 2007 |
| January 2009 (final data collection date for primary outcome measure) |
- 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 ]
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- 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.
- 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
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| Complete list of historical versions of study NCT00469170 on ClinicalTrials.gov Archive Site |
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| A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method |
| A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women |
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. |
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| Phase 0 |
| Interventional |
| Prevention, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety Study |
| HIV Infections |
| Device: intravaginal ring |
- Experimental: vaginal ring first 12 weeks & observational safety last 12 weeks
- Experimental: observational safety first 12 weeks & vaginal ring last 12 weeks
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| Recruiting |
| 200 |
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| January 2009 (final data collection date for primary outcome measure) |
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
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| Female |
| 18 Years to 35 Years |
| Yes |
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| Kenya, South Africa, Tanzania |
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| NCT00469170 |
| Zeda Rosenberg ScD, International Partnership for Microbicides |
| IPM 011 |
| International Partnership for Microbicides, Inc. |
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| Study Director: |
Dr. Annalene Nel |
IPM |
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| International Partnership for Microbicides, Inc. |
| August 2009 |