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Clinical Trial: Randomized Controlled Trial of SAVVY and HIV in Ghana
This study is no longer recruiting patients.
|
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 transmission | Drug: 1.0% C31G SAVVY vaginal gel | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Study Details:
Primary Outcomes: combined incidence of HIV-1 and HIV-2
Expected Total Enrollment: 2142
Expected Total Enrollment: 2142
Study start: 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 - 35 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- 18 to 35 year old women
- HIV negative
- more than one sexual partner in past 3 months
- average 3 coital acts per week
- willing to use vaginal gel and condoms for 12 months
Exclusion Criteria:
- HIV positive
- pregnant
Location Information
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
Study chairs or principal investigators
Leigh Peterson, PhD, Study Chair, Family Health International
More Information
Study ID Numbers: 9779
Last Updated: August 11, 2005
Record first received: August 11, 2005
ClinicalTrials.gov Identifier: NCT00129532
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 11, 2005
Record first received: August 11, 2005
ClinicalTrials.gov Identifier: NCT00129532
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Estropipate Vaginal Cream (Drug Digest)
- Ogen (Drug Digest)
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