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

• Sponsor: AIDS Healthcare Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT03399903
• Collaborator: HIV Immunotherapeutics Institute (Other)
• Enrollment: 47
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.7
• Patients Per Site Per Month: 2.1

Study Details

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
• 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: Mar 22, 2019
• Actual Study Completion Date: Mar 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 [14 weeks]

   C-reactive protein

Secondary Outcome Measures

1. Flow cytometry for cellular immune activation [14 weeks]

   Immune activation

2. Plasma markers of microbial translocation [14 weeks]

   Microbial translocation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AIDS Healthcare Foundation
• ClinicalTrials.gov Identifier: NCT03399903
• Other Study ID Numbers: HII-03
• First Posted: Jan 17, 2018
• Last Update Posted: Mar 4, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Mesalamine

Study Results

No Results Posted as of Mar 4, 2020