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Sponsored by: |
International Partnership for Microbicides, Inc. |
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Information provided by: | International Partnership for Microbicides, Inc. |
ClinicalTrials.gov Identifier: | NCT00469170 |
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 |
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
|
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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International Centre for Reproductive Health | Withdrawn |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. 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 | 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 |
Study Director: | Dr. Annalene Nel | IPM |
Responsible Party: | International Partnership for Microbicides ( Karen Douville, Executive Director for Operations & Planning ) |
Study ID Numbers: | IPM 011 |
Study First Received: | May 3, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00469170 |
Health Authority: | South Africa: Medicines Control Council; Kenya: Ministry of Health; Tanzania: Food & Drug Administration |
HIV-1 HIV seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |