Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069498
Status:
COMPLETED
Last Update Posted:
2007-05-25
First Post:
2003-09-26
Brief Title:
Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Impact of Co-Receptor and HIV Viral Burden on Gut Mucosa
Status:
COMPLETED
Status Verified Date:
2006-07
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 lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of the immune system Like other parts of the immune system HIV attacks this lymphoid tissue This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in the gastrointestinal tracts of people with HIV
Detailed Description:
The gastrointestinal tract is the bodys largest lymphoid organ Because it contains significant numbers of activated memory T lymphocytes it is a prime site for HIV infection and amplification Mucosal T cells are extremely vulnerable to HIV infection due in part to a marked increase in CCR5 co-receptors Understanding the impact of HIV on the gastrointestinal-associated lymphoid tissue GALT is essential and may provide insight into the profound drop in mucosal lymphocytes during early infection persistence of tissue viral replication in the setting of undetectable plasma viral activity and compartmentalization of HIV
Pre-clinical studies have demonstrated that the mucosal compartment in HIV uninfected individuals is characterized by features which enhance vulnerability to HIV infection compared to blood Once infected the mucosal response to HIV is inflammation This study will further evaluate the inflammatory response of mucosal tissue to HIV by examining the effect of the anti-inflammatory drug 5-aminosalicylic acid 5-ASA on the gut mucosa
Participants in this study will be randomly assigned to receive either 5-ASA or placebo Participants will be enrolled in the study for 8 weeks participants may then elect to continue on 5-ASA for an additional 16 weeks Participants will have four screening visits in the month prior to beginning the study and four study visits during the 8-week study Assessments will include medical interviews and physical exams sigmoidoscopy with mucosal biopsy and blood tests
Pre-clinical studies have demonstrated that the mucosal compartment in HIV uninfected individuals is characterized by features which enhance vulnerability to HIV infection compared to blood Once infected the mucosal response to HIV is inflammation This study will further evaluate the inflammatory response of mucosal tissue to HIV by examining the effect of the anti-inflammatory drug 5-aminosalicylic acid 5-ASA on the gut mucosa
Participants in this study will be randomly assigned to receive either 5-ASA or placebo Participants will be enrolled in the study for 8 weeks participants may then elect to continue on 5-ASA for an additional 16 weeks Participants will have four screening visits in the month prior to beginning the study and four study visits during the 8-week study Assessments will include medical interviews and physical exams sigmoidoscopy with mucosal biopsy and blood tests
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 |
|---|---|---|---|
| K24AI001610-03 | NIH | None | httpsreporternihgovquickSearchK24AI001610-03 |