Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107679
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2005-04-06
Brief Title:
A Study of Anal Cancer Development in HIV Infected People
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Anal Dysplasia A Substudy of a Large Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy The SMART Study
Status:
COMPLETED
Status Verified Date:
2014-04
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 compare the development of abnormal cell growth or cancer in the anal region of individuals who are receiving one of two different anti-HIV treatment strategies
Detailed Description:
Human papillomavirus HPV is a common viral infection among men and women Individuals with HPV are at risk for anal dysplasia a condition that may lead to anal cancer It has been observed that HIV progresses more rapidly in individuals coinfected with HPV and HIV compared to people with either disease alone Studies that have investigated the effect of highly active antiretroviral therapy HAART on the progression of anal dysplasia have been contradictory and inconclusive The role of CD4 count and HIV suppression and their contributions to the progression of anal disease needs to be determined This trial is a substudy of a study of management of antiretroviral therapy SMART In the SMART study patients will participate in one of two strategies a drug conservation DC strategy and a viral suppression VS strategy Participants in the DC group will stop or defer HAART then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cellsmm3 Participants in the VS group will receive HAART to maintain a viral load as low as possible regardless of CD4 count This study will compare the times to development of high-grade anal dysplasia or anal cancer in participants who are currently enrolled in the SMART study
Patients will participate in this substudy and the main SMART study at the same time At the baseline visit participants will undergo an anal swab some female participants will have a cervical swab as well Participants will provide a detailed sexual history including sexually transmitted infections a history of anal-related conditions and a history of alcohol and recreational drug use These procedures will be repeated at each annual follow-up visit Some participants may undergo additional anal cytology and high-resolution anoscopy with biopsy Participants will be followed until they develop high-grade anal dysplasia or anal cancer or when the SMART study closes whichever comes first
Patients will participate in this substudy and the main SMART study at the same time At the baseline visit participants will undergo an anal swab some female participants will have a cervical swab as well Participants will provide a detailed sexual history including sexually transmitted infections a history of anal-related conditions and a history of alcohol and recreational drug use These procedures will be repeated at each annual follow-up visit Some participants may undergo additional anal cytology and high-resolution anoscopy with biopsy Participants will be followed until they develop high-grade anal dysplasia or anal cancer or when the SMART study closes whichever comes first
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 |
|---|---|---|---|
| 10117 | REGISTRY | DAIDS-ES | None |
| SMART | None | None | None |