Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153777
Status:
TERMINATED
Last Update Posted:
2015-08-28
First Post:
2005-09-08
Brief Title:
Cellulose Sulfate and HIV Transmission Among Women
Sponsor:
CONRAD
Organization:
CONRAD
Study Overview
Official Title:
Randomized Controlled Trial of 6 Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IDMC recommendation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine the effect of cellulose sulfate on the transmission of HIV to women via vaginal intercourse The secondary objectives are the effect on the transmission of gonorrhea and chlamydia via the same route
The study hypothesis is that there will be no effect
The study hypothesis is that there will be no effect
Detailed Description:
Despite the availability of an effective HIV prevention method ie the condom the epidemic continues growing There is thus an urgent need for additional HIV prevention methods One of the possibilities is the use of microbicides ie chemical products which may be used in the vagina or rectum with the potential to prevent HIV infection
Cellulose sulfate is an HIV entry inhibitor with an in vitro effect on N gonorrhoeae NG and C trachomatis CT and other sexually transmitted organisms
The study assess its effect on the vaginal transmission of HIV NG and CT among women at high risk of heterosexual STI infection defined as having had more than two partners in the last three months and an average of three sexual acts per week
The study is randomized triple-blinded placebo controlled
Cellulose sulfate is an HIV entry inhibitor with an in vitro effect on N gonorrhoeae NG and C trachomatis CT and other sexually transmitted organisms
The study assess its effect on the vaginal transmission of HIV NG and CT among women at high risk of heterosexual STI infection defined as having had more than two partners in the last three months and an average of three sexual acts per week
The study is randomized triple-blinded placebo controlled
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