Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000758
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase III Randomized Trial of Topical Vaginal Fluorouracil 5-Fluorouracil 5-FU Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Trial of Topical Vaginal Fluorouracil 5-Fluorouracil 5-FU Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy surgery for high-grade cervical dysplasia pre-cancer of the cervix cervical intraepithelial neoplasia To correlate time to recurrence of cervical dysplasia with T-cell function
Women with HIV infection are at greater risk for cervical dysplasia Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer there is an urgent need to develop appropriate therapies
Women with HIV infection are at greater risk for cervical dysplasia Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer there is an urgent need to develop appropriate therapies
Detailed Description:
Women with HIV infection are at greater risk for cervical dysplasia Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer there is an urgent need to develop appropriate therapies
Patients are randomized to receive either intravaginal fluorouracil or no treatment observation only Fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months Patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy
Patients are randomized to receive either intravaginal fluorouracil or no treatment observation only Fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months Patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11176 | REGISTRY | DAIDS ES Registry Number | None |