Viewing Study NCT00130078



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Last Modification Date: 2024-10-26 @ 9:13 AM
Study NCT ID: NCT00130078
Status: UNKNOWN
Last Update Posted: 2005-09-26
First Post: 2005-08-11

Brief Title: Trial of SAVVY Vaginal Gel and HIV in Nigeria
Sponsor: Biosyn
Organization: Biosyn

Study Overview

Official Title: Randomized Controlled Trial of SAVVY and HIV in Nigeria
Status: UNKNOWN
Status Verified Date: 2005-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 10 C31G SAVVY vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk
Detailed 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 10 C31G SAVVY vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None