Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001073
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions 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:
The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous
Cervical tumors are found in both HIV-infected and HIV-negative women However HIV-infected women are at a greater risk and often their tumors become cancerous more quickly than those in HIV-negative women Isotretinoin may be able to prevent this from happening However since these tumors tend to disappear over time many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves
Cervical tumors are found in both HIV-infected and HIV-negative women However HIV-infected women are at a greater risk and often their tumors become cancerous more quickly than those in HIV-negative women Isotretinoin may be able to prevent this from happening However since these tumors tend to disappear over time many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves
Detailed Description:
Cervical neoplasia is frequently seen in HIV-infected women apparently resulting from immunosuppression and common risk factors including sexual behavior patterns In HIV seronegative women progression of preinvasive neoplasia is relatively slow and up to 40 percent of low grade squamous intraepithelial lesions grade I CINHPV-associated changes regress to a normal appearance over time Many clinicians have opted not to treat CIN IHPV-associated changes due to this high spontaneous regression rate Currently retinoids principally isotretinoin are the most consistently effective medical therapy for CINHPV-associated changes but use of isotretinoin in HIV-infected patients has not been extensively documented AS PER AMENDMENT 61097
Patients are randomized to receive oral isotretinoin for 6 months or be observed only for 6 months with 12 additional months of follow-up AS PER AMENDMENT 72399 Follow-up time has been decreased to 9 months from the last patient enrolled
Patients are randomized to receive oral isotretinoin for 6 months or be observed only for 6 months with 12 additional months of follow-up AS PER AMENDMENT 72399 Follow-up time has been decreased to 9 months from the last patient enrolled
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 |
|---|---|---|---|
| 11269 | REGISTRY | DAIDS ES Registry Number | None |