Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120770
Status:
TERMINATED
Last Update Posted:
2007-02-28
First Post:
2005-07-11
Brief Title:
Cellulose Sulfate CS Gel and HIV in Nigeria
Sponsor:
FHI 360
Organization:
FHI 360
Study Overview
Official Title:
Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria
Status:
TERMINATED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was halted in January 2007 due to safety concerns
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 3 multi-center randomized placebo-controlled trial to determine the effectiveness and safety of the 6 cellulose sulfate CS vaginal gel for the prevention of HIV infection
Detailed Description:
This is a Phase 3 multi-center randomized placebo-controlled trial to assess the effectiveness of CS gel in preventing male-to-female vaginal transmission of HIV among HIV sero-negative women at high risk for HIV infection Eligible participants who are HIV negative at risk for becoming infected and are willing to use a vaginal microbicide each time they have intercourse throughout 12 months of study participation will be recruited in Port Harcourt and Lagos Nigeria The enrollment phase will last until 2160 women have enrolled It is anticipated that the enrollment will be completed within 12 months
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