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Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients Clinical research trials and Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients. Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients clinical trial. Participants frequently obtain the most expert healthcare available for their Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients  Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients
Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria - HIV infected - Stable plasma viral load between 500 and 100,000 copies/ml for 3 months prior to study entry - Stable antiretroviral therapy for at least 3 months prior to study entry - CD4 cell count greater than or equal to 200 cells/mm3 - Mucosal viral RNA greater than or equal to 100 copies/microg total RNA within 2 weeks of study entry Exclusion Criteria - Allergy or intolerance to salicylates - Gastrointestinal tract infection causing diarrhea or colonic inflammation - Renal or hepatic disease - Current opportunistic infection - History of extensive small bowel resection (greater than 1/2 the length of the small intestine) - History of intestinal mucosal disease (except HIV) - Chronic, regular use of aspirin and/or anti-inflammatory agents within 7 weeks prior to study entry - Oral, topical, or rectal steroids or 5-ASA within 3 months prior to study entry - Certain laboratory abnormalities - Significant neuropsychiatric symptoms that in the opinion of the study official could impact the conduct or outcome of the study
Total Enrollment: 14
Location and Contact Information:
Overall Study Official:
PeterAnton, Principal Investigator, David Geffen School of Medicine at UCLA
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: K24 AI01610-03;
Study Start Date: October 1999
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069498
Other Hiv Infections Studies:
1. Once-Daily Drug Regimen for HIV-Infected Patients
2. An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
3. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy
4. Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV
5. The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients
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