Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection

AIDS Healthcare Foundation (AHF)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Gut Inflammation

HIV-1-infection

Treatments

Drug: Pentasa vs Align

Study type

Interventional

Funder types

Other

Identifiers

NCT03399903

HII-03

Details and patient eligibility

About

An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.

Full 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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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