Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304642
Status:
COMPLETED
Last Update Posted:
2006-06-02
First Post:
2006-03-16
Brief Title:
A Study to Assess the Pharmacokinetics of Dapivirine TMC120 Vaginal Microbicide Gel
Sponsor:
International Partnership for Microbicides Inc
Organization:
International Partnership for Microbicides Inc
Study Overview
Official Title:
A Study to Assess the Pharmacokinetics of Dapivirine TMC120 Vaginal Microbicide Gel in Healthy HIV-Negative Women
Status:
COMPLETED
Status Verified Date:
2006-06
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:
Approximately 18 women will be enrolled in this single-center double-blind randomized Phase I study to assess vaginal tissue and fluid levels plasma levels and pharmacokinetics of dapivirine TMC120 gel which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50 Volunteers will be randomized in a 111 ratio to receive 25mL dapivirine vaginal microbicide gel at one of three concentrations
Detailed Description:
None
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