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Trial of SAVVY and HIV in Ghana
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by Biosyn.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Biosyn
Collaborators:
FHI 360
United States Agency for International Development (USAID)
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00129532
First received: August 11, 2005
Last updated: September 7, 2005
Last verified: August 2005
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Purpose
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: 1.0% C31G SAVVY vaginal gel | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Randomized Controlled Trial of SAVVY and HIV in Ghana |
Resource links provided by NLM:
Further study details as provided by Biosyn:
Primary Outcome Measures:
- combined incidence of HIV-1 and HIV-2
| Estimated Enrollment: | 2142 |
| Study Start Date: | January 2004 |
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 18 to 35 year old women
- HIV negative
- More than one sexual partner in past 3 months
- Average of 3 coital acts per week
- Willing to use vaginal gel and condoms for 12 months
Exclusion Criteria:
- HIV positive
- Pregnant
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129532
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129532
Locations
| Ghana | |
| Noguchi Memorial Institute for Medical Research/University of Ghana | |
| Accra, Ghana | |
| Komfo Anokye Teaching Hospital/Kwame Nkrumah University of Science and Technology | |
| Kumasi, Ghana | |
Sponsors and Collaborators
Biosyn
FHI 360
United States Agency for International Development (USAID)
Investigators
| Study Chair: | Leigh Peterson, PhD | FHI 360 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00129532 History of Changes |
| Other Study ID Numbers: |
9779 |
| Study First Received: | August 11, 2005 |
| Last Updated: | September 7, 2005 |
Keywords provided by Biosyn:
|
HIV transmission |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on July 24, 2017