Clinical trial NCT03399903: Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
Official title: Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV-1-infection
Gut Inflammation
Lead sponsor: AIDS Healthcare Foundation
Sponsor class: OTHER
Collaborators: name: HIV Immunotherapeutics Institute
First posted: 2018-01-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammation markers
timeFrame: 14 weeks
Secondary outcomes:
measure: Flow cytometry for cellular immune activation
timeFrame: 14 weeks
measure: Plasma markers of microbial translocation
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation - Public Health Division
state: California
Study officials:
affiliation: AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
name: Otto O Yang, MD
role: STUDY_DIRECTOR
affiliation: AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
name: Peter Anton, MD
role: PRINCIPAL_INVESTIGATOR
References: