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

• ClinicalTrials.gov Identifier: NCT03399903
• Recruitment Status: Completed
• First Posted: January 17, 2018
• Last Update Posted: March 4, 2020
• Sponsor: AIDS Healthcare Foundation
• Collaborator: HIV Immunotherapeutics Institute
• Information provided by (Responsible Party): AIDS Healthcare Foundation

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
HIV-1-infection; Gut Inflammation	Drug: Pentasa vs Align	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: March 22, 2019
• Actual Study Completion Date: March 22, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Inflammation markers [ Time Frame: 14 weeks ]
   C-reactive protein

Secondary Outcome Measures :

1. Flow cytometry for cellular immune activation [ Time Frame: 14 weeks ]
   Immune activation
2. Plasma markers of microbial translocation [ Time Frame: 14 weeks ]
   Microbial translocation

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

AIDS Healthcare Foundation - Public Health Division

Los Angeles, California, United States, 90027

Sponsors and Collaborators

AIDS Healthcare Foundation

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

More Information

• Responsible Party: AIDS Healthcare Foundation
• ClinicalTrials.gov Identifier: NCT03399903
• Other Study ID Numbers: HII-03
• First Posted: January 17, 2018
• Last Update Posted: March 4, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Infections; Communicable Diseases; HIV Infections; Inflammation; Disease Attributes; Pathologic Processes; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mesalamine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents