Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140764
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2005-08-30
Brief Title:
Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-08
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 intervention is to find out whether intravaginal treatment with a gel containing an antibiotic metronidazole compared to a similar placebo gel without antibiotic can reduce the frequency of bacterial vaginosis a common vaginal infection among African women who are HIV uninfected or HIV infected The study will also determine the effect of these vaginal gels on genitourinary symptoms
Detailed Description:
This is a phase 3 randomized double masked two arms study conducted in Malawi Southeast Africa The study is conducted among nonpregnant HIV infected or uninfected women of reproductive age Intermittent mass treatment approaches are followed where women are randomized to antibiotic intravaginal treatment or placebo at enrollment Women receive assigned product every three months for one year
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