Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132444
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2005-07-11
Brief Title:
Study of UC-781 Vaginal Microbicide
Sponsor:
CONRAD
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Heterosexual Women and Their Male Partners
Status:
COMPLETED
Status Verified Date:
2010-01
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:
This study will help determine whether the agent UC-781 formulated as a gel is safe when applied to the vagina twice daily for 14 days It will also assess whether women find the gel acceptable to use
Detailed Description:
Purpose To assess the safety and acceptability of vaginal use of 01 and 025 UC-781 gel in sexually active HIV-uninfected women and their male partners and sexually abstinent HIV-infected women
Design Single-center phase I randomized double-blind controlled trial with 14 days of twice-daily product or control gel exposure
Study population Sexually active HIV-uninfected women at low-risk for HIV and their male partners sexually-abstinent HIV-infected women all age 18-45
Size 36 sexually active HIV-uninfected women and up to 36 of their male partners 18 sexually abstinent HIV-infected women
Treatment regimen
Stage 1 HIV-uninfected sexually active women and 1 male partner per woman
12 women assigned to 01 UC-781 twice daily x 14 days 12 women assigned to 025 UC-781 twice daily x 14 days 12 women assigned to control gel twice daily X 14 days
Stage 2 HIV-infected abstinent women 12 assigned to 025 UC-781 twice daily x 14 days 6 assigned to control gel twice daily x 14 days
Study duration Participant accrual will take 6 months Each participant will be followed for 14 days in Stage 1 and 21 days in Stage 2 Total study duration will be 9 months
Study Site The Hope Clinic of Emory University Decatur GA
Primary Objectives
To assess the safety and toxicity of 01 UC-781 gel and 025 UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually active HIV-uninfected women
To assess the safety and toxicity of 025 UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually abstinent HIV-infected women
Secondary Objectives
To assess the acceptability of 01 and 025 UC-781 gel administered intravaginally twice-daily for 14 days among HIV-uninfected and the acceptability of 025 gel similarly administered to HIV-infected women
To assess the effect of study product on vaginal microflora of HIV-uninfected and HIV-infected women
To assess the systemic absorption of 01 and 025 UC-781 gel when administered intravaginally
To assess HIV viral load in genital secretions in HIV-infected women during 025 UC-781 gel use
To assess the genotypic resistance patterns of HIV in genital secretions and peripheral blood in HIV-infected women during 025 UC-781 gel use
To assess the acceptability of 01 and 025 UC-781 gel in male sexual partners of HIV-uninfected women
Primary Endpoints
The safety and toxicity of 01 UC-781 gel and 025 UC-781 gel administered intravaginally twice-daily for 14 days in sexually-active HIV-uninfected women and 025 UC-781 gel administered in sexually-abstinent HIV-infected women will be assessed by
Macroscopic andor microscopic evidence of vulvar andor vaginal epithelium damage including ulceration abrasion severe erythema andor severe edema
Macroscopic andor microscopic evidence of cervical mucosal damage including ulceration abrasion severe erythema andor severe edema
Symptoms of genital irritation including burning itching or soreness
Laboratory evidence of grade 3 or higher toxicity for hematology liver or renal function which cannot be attributed to another cause
Secondary Endpoints
Acceptability of 01 and 025 UC-781 gel use by HIV-uninfected and 025 UC-781 gel use by HIV-infected women will be assessed by
Proportion of participants who at Day 14 visit indicate they would be somewhat unlikely or very unlikely to use 01 and 025 UC-781 gel during sexual intercourse in the future compared to control gel users
Reported positive aspects of using 01 and 025 UC-781 gel compared to control gel users
Reported negative aspects of using 01 and 025 UC-781 gel compared to control gel users
Design Single-center phase I randomized double-blind controlled trial with 14 days of twice-daily product or control gel exposure
Study population Sexually active HIV-uninfected women at low-risk for HIV and their male partners sexually-abstinent HIV-infected women all age 18-45
Size 36 sexually active HIV-uninfected women and up to 36 of their male partners 18 sexually abstinent HIV-infected women
Treatment regimen
Stage 1 HIV-uninfected sexually active women and 1 male partner per woman
12 women assigned to 01 UC-781 twice daily x 14 days 12 women assigned to 025 UC-781 twice daily x 14 days 12 women assigned to control gel twice daily X 14 days
Stage 2 HIV-infected abstinent women 12 assigned to 025 UC-781 twice daily x 14 days 6 assigned to control gel twice daily x 14 days
Study duration Participant accrual will take 6 months Each participant will be followed for 14 days in Stage 1 and 21 days in Stage 2 Total study duration will be 9 months
Study Site The Hope Clinic of Emory University Decatur GA
Primary Objectives
To assess the safety and toxicity of 01 UC-781 gel and 025 UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually active HIV-uninfected women
To assess the safety and toxicity of 025 UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually abstinent HIV-infected women
Secondary Objectives
To assess the acceptability of 01 and 025 UC-781 gel administered intravaginally twice-daily for 14 days among HIV-uninfected and the acceptability of 025 gel similarly administered to HIV-infected women
To assess the effect of study product on vaginal microflora of HIV-uninfected and HIV-infected women
To assess the systemic absorption of 01 and 025 UC-781 gel when administered intravaginally
To assess HIV viral load in genital secretions in HIV-infected women during 025 UC-781 gel use
To assess the genotypic resistance patterns of HIV in genital secretions and peripheral blood in HIV-infected women during 025 UC-781 gel use
To assess the acceptability of 01 and 025 UC-781 gel in male sexual partners of HIV-uninfected women
Primary Endpoints
The safety and toxicity of 01 UC-781 gel and 025 UC-781 gel administered intravaginally twice-daily for 14 days in sexually-active HIV-uninfected women and 025 UC-781 gel administered in sexually-abstinent HIV-infected women will be assessed by
Macroscopic andor microscopic evidence of vulvar andor vaginal epithelium damage including ulceration abrasion severe erythema andor severe edema
Macroscopic andor microscopic evidence of cervical mucosal damage including ulceration abrasion severe erythema andor severe edema
Symptoms of genital irritation including burning itching or soreness
Laboratory evidence of grade 3 or higher toxicity for hematology liver or renal function which cannot be attributed to another cause
Secondary Endpoints
Acceptability of 01 and 025 UC-781 gel use by HIV-uninfected and 025 UC-781 gel use by HIV-infected women will be assessed by
Proportion of participants who at Day 14 visit indicate they would be somewhat unlikely or very unlikely to use 01 and 025 UC-781 gel during sexual intercourse in the future compared to control gel users
Reported positive aspects of using 01 and 025 UC-781 gel compared to control gel users
Reported negative aspects of using 01 and 025 UC-781 gel compared to control gel users
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