Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170430
Status:
COMPLETED
Last Update Posted:
2010-03-18
First Post:
2005-09-09
Brief Title:
Reducing Vaginal Infections in Women
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Reducing Vaginal Infections in Women at Risk for HIV-1
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if taking medication once a month can help to decrease the risk of vaginal infections Additionally researchers will study whether personal habits such as douching bathing and sexual practices can influence the risk of vaginal infections Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually transmitted diseases STDs Study participants will include 400 female prostitutes ages 16 and older living in Mombasa Study procedures will include sexual behavior questions physical examinations including pelvic exams testing of vaginal and cervical secretions for STDs urine collection and blood samples Participants will receive 2 different types of pills to treat vaginal infections metronidazole or fluconazole or placebo contains no medication Participants will be involved in study related procedures for 1 year and will return to the study clinic at one month intervals
Detailed Description:
Prospective studies in Africa have demonstrated that vaginal infections are associated with a significant increase in a womans risk of infection with HIV-1 Further clinical and epidemiological research is needed to evaluate strategies for prevention and treatment of vaginal infections as a means of reducing HIV-1 acquisition Developing a vaginal health intervention to reduce the risk of HIV-1 infection is a particularly important goal in sub-Saharan Africa where female controlled strategies for reducing the risk of HIV-1 transmission may be an important means of decreasing the spread of the epidemic This study will evaluate the efficacy of a regimen for reducing the rate of vaginal infections The study is a double blind randomized controlled trial of monthly treatment with single-dose metronidazole and fluconazole as a means of decreasing vaginal infections and promoting normal vaginal flora in HIV-1 seronegative female sex workers FSWs in Mombasa Kenya Participants will be recruited from an existing cohort of HIV-1 seronegative FSWs followed at a municipal sexually transmitted disease STD clinic in Mombassa Kenya since February 1993 Participants will be randomized to treatment with metronidazole 2 grams plus fluconazole 150 mg once a month or placebo All patients will be asked to return for follow-up after 1 month All women in the study will be treated as indicated for symptomatic vaginal infections other genital track infections and followed until they have completed 12 monthly follow-up visits
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-125 | Other Identifier | University of Washington Human Subjects Division | None |
| 01-0777-A 01 | OTHER | None | None |