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| Sponsored by: |
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 |
| MedlinePlus related topics: | AIDS |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Karen Douville | 301-608-2221 | kdouville@ipm-microbicides.org |
| Kenya | |||||
| International Centre for Reproductive Health | Withdrawn | ||||
| Mombasa, Kenya | |||||
| South Africa | |||||
| Desmond Tutu HIV Foundation, Masiphumelele | Not yet 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. Danielle Klemp | |||||
| 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 | Recruiting | ||||
| Durban, KwaZulu Natal, South Africa, 4067 | |||||
| Principal Investigator: Dr. Avashri Naidoo | |||||
| Tanzania | |||||
| Kilimanjaro Reproductive Health Program | Recruiting | ||||
| Moshi, Tanzania | |||||
| Contact: Dr. Saidi Kapiga 255-272-750663 Saidi.Kapiga@lshtm.ac.uk | |||||
| Sub-Investigator: Dr. Sarah Chiduo | |||||
| Principal Investigator: Dr. Gileard Masenga | |||||
| Sub-Investigator: Dr. Saidi Kapiga | |||||
| International Partnership for Microbicides, Inc. |
| Study Director: | Dr. Annalene Nel | IPM |
More Information
| Responsible Party: | International Partnership for Microbicides ( Karen Douville, Executive Director for Operations & Planning ) |
| Study ID Numbers: | IPM 011 |
| First Received: | May 3, 2007 |
| Last Updated: | July 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00469170 |
| Health Authority: | South Africa: Medicines Control Council; Kenya: Ministry of Health; Tanzania: Food & Drug Administration |
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