Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213044
Status:
COMPLETED
Last Update Posted:
2017-08-15
First Post:
2005-09-13
Brief Title:
A Randomized Controlled Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women
Sponsor:
Population Council
Organization:
Population Council
Study Overview
Official Title:
A Randomized Controlled Double-Blind Cross-Over Trial of Safety Effect on Genital Tract HIV Shedding and Acceptability of Vaginal Use of Carraguard by HIV-Infected Women
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
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:
Randomized controlled double-blinded cross-over trial of 60 HIV-infected women recruited from general medical clinics family planning clinics groupsorganizations working with persons living with AIDS to assess product safety effect on genital tract HIV shedding and product acceptability with vaginal use of Carraguard gel among HIV-infected women Women had to be abstinent or in a seroconcordant relationship with only one partner for the study period
Detailed Description:
Carraguard PC-515 the Population Councils lead candidate microbicide was tested in a randomized controlled trial in Chiang Rai northern Thailand Safety of daily product use determined by symptoms of irritation effect on vaginal flora vaginal epithelial disruption as determined by naked eye inspection Day 7 and Day 14 of each arm and colposcopic inspection on Day 7 and other adverse effects which may include UTI or other unforeseen problems Day 7 and Day 14
Genital tract HIV will be measured using samples collected by CVL Day 7 and Day 14 of each arm and vaginal swab Day 7 and Day 14
Product acceptability will be assessed through an interview-administered questionnaire once each study arm at the first follow-up visit Day 7 of each arm after using the product daily for 7 days
Genital tract HIV will be measured using samples collected by CVL Day 7 and Day 14 of each arm and vaginal swab Day 7 and Day 14
Product acceptability will be assessed through an interview-administered questionnaire once each study arm at the first follow-up visit Day 7 of each arm after using the product daily for 7 days
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