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

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

Study Overview

• Status: Completed
• Conditions: HIV-1-infection; Gut Inflammation
• Intervention / Treatment: Drug: Pentasa vs Align

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • AIDS Healthcare Foundation - Public Health Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pentasa; 40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks	Drug: Pentasa 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.
Active Comparator: Align; 40 participants will be randomized to take Align tablets, once daily for 8 weeks	Drug: Pentasa 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation markers	C-reactive protein	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow cytometry for cellular immune activation	Immune activation	14 weeks
Plasma markers of microbial translocation	Microbial translocation	14 weeks

Collaborators and Investigators

• Sponsor: AIDS Healthcare Foundation
• Collaborators: HIV Immunotherapeutics Institute
• Investigators: Study Director: Otto O Yang, MD, AIDS Healthcare Foundation - HIV Immunotherapeutics Institute; Principal Investigator: Peter Anton, MD, AIDS Healthcare Foundation - HIV Immunotherapeutics Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): March 22, 2019
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; HIV Infections; Inflammation; Infections; Communicable Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: HII-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No