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

Primary Purpose

HIV-1-infection, Gut Inflammation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pentasa vs Align
Sponsored by
AIDS Healthcare Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV-1-infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • AIDS Healthcare Foundation - Public Health Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pentasa

Align

Arm Description

40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks

40 participants will be randomized to take Align tablets, once daily for 8 weeks

Outcomes

Primary Outcome Measures

Inflammation markers
C-reactive protein

Secondary Outcome Measures

Flow cytometry for cellular immune activation
Immune activation
Plasma markers of microbial translocation
Microbial translocation

Full Information

First Posted
January 9, 2018
Last Updated
March 2, 2020
Sponsor
AIDS Healthcare Foundation
Collaborators
HIV Immunotherapeutics Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03399903
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Healthcare Foundation
Collaborators
HIV Immunotherapeutics Institute

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection, Gut Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentasa
Arm Type
Experimental
Arm Description
40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks
Arm Title
Align
Arm Type
Active Comparator
Arm Description
40 participants will be randomized to take Align tablets, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Pentasa vs Align
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inflammation markers
Description
C-reactive protein
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Flow cytometry for cellular immune activation
Description
Immune activation
Time Frame
14 weeks
Title
Plasma markers of microbial translocation
Description
Microbial translocation
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otto O Yang, MD
Organizational Affiliation
AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Anton, MD
Organizational Affiliation
AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDS Healthcare Foundation - Public Health Division
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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