Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385554
Status:
WITHDRAWN
Last Update Posted:
2012-08-16
First Post:
2006-10-05
Brief Title:
Botswana Study of UC-781 Vaginal Microbicide
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Phase I Trial of the Safety Toxicity and Acceptability of the Microbicide UC-781 When Topically Applied by HIV-uninfected Women and Men in Botswana
Status:
WITHDRAWN
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study product is no longer being considered for further development
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the safety side effects and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks
Detailed Description:
45 women and 45 men all healthy and sexually active 21-45 years old without HIV infection will be enrolled in Francistown and Gaborone Botswana Volunteers will be randomized to receive either 01 or 025 UC-781 carbomer gel or placebo gel 3 arms Women will be instructed to apply gel intravaginally morning and evening and prior to sex always with male condom use for 14 consecutive days Men will be instructed to apply gel topically for 14 consecutive nights before bed allow to dry overnight and wash it off in the morning Additionally instructed never to use gel during sex but always to use condoms Volunteers will be seen weekly for evaluation of symptoms laboratory toxicities genital exam findings with colposcopy for women and plasma drug levels Acceptability will be assessed in focus groups in the month after completing gel use
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 |
|---|---|---|---|
| BOTUSA MB05 | None | None | None |