Gut Inflammation, HIV-1-infection
Conditions
Brief summary
An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.
Detailed description
The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.
Interventions
DRUGPentasa vs Align
We will examine the safety and possible effectiveness of Pentasa® and Align in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.
Sponsors
HIV Immunotherapeutics Institute
AIDS Healthcare Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age at least 18 * On ART for at least 1 year during which: viremia \<50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of \<100), and CD4 T cell count consistently \>500 during that time * CD4 T cell nadir \>350 * Last CD4 and T cell test in past 6 months
Exclusion criteria
* Plans to modify antiretroviral therapy in the next 12 weeks for any reason * History of inflammatory bowel disease or irritable bowel disease * Chronic active hepatitis B or C * History of autoimmune disease * Hypersensitivity to any component of Pentasa * Clostridium difficile infection * Receiving rectally delivered medications * Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors) * Receiving immunosuppressive steroids * Receiving any medications associated with bleeding risk * Hemoglobin \< 10.0 g/dL * Platelet count less than 100,000/mm3 * White blood cell count \< 2,000 cells/mm3 or \> 15,000 cells/mm3 * Symptoms of sexually transmitted infection * Antibiotics used in the last 90 days * Renal insufficiency with creatinine clearance less than 50 ml/min * Elevated transaminases greater than 2.5 times the upper limit of normal * Evidence of decompensated cirrhosis, heart failure * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation markers | 14 weeks | C-reactive protein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow cytometry for cellular immune activation | 14 weeks | Immune activation |
| Plasma markers of microbial translocation | 14 weeks | Microbial translocation |
Countries
United States
Outcome results
None listed