Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Impact of Co-Receptor and HIV Viral Burden on Gut Mucosa|
- Safety of 4.8 g/day 5-ASA in HIV infected patients with detectable viral load
- Time/trend decrease in mucosal viral RNA load and plasma viral RNA load, compared to placebo
- reduction in cellular infiltration in treated patients versus those taking placebo
- change in inflammation, as measured by tissue destruction
- reduction in soluble inflammation (RANTES), CCR5 expression, and cellular infiltration of CD8
- changes in certain activation markers in gut
|Study Start Date:||October 1999|
The gastrointestinal tract is the body’s 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069498
|United States, California|
|David Geffen School of Medicine at UCLA|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Peter A. Anton, MD||University of California, Los Angeles|