Trial of SAVVY and HIV in Ghana
This trial is active, not recruiting.
|Treatment||1.0% c31g savvy vaginal gel|
|Start date||January 2004|
|Trial size||2142 participants|
|Trial identifier||NCT00129532, 9779|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Accra, Ghana||Noguchi Memorial Institute for Medical Research/University of Ghana||no longer recruiting|
|Kumasi, Ghana||Komfo Anokye Teaching Hospital/Kwame Nkrumah University of Science and Technology||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
combined incidence of HIV-1 and HIV-2
Female participants from 18 years up to 35 years old.
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
|Official title||Randomized Controlled Trial of SAVVY and HIV in Ghana|
|Description||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.|
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