Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
1 other identifier
interventional
47
1 country
1
Brief Summary
An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2018
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2019
CompletedMarch 4, 2020
March 1, 2020
1.9 years
January 9, 2018
March 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Inflammation markers
C-reactive protein
14 weeks
Secondary Outcomes (2)
Flow cytometry for cellular immune activation
14 weeks
Plasma markers of microbial translocation
14 weeks
Study Arms (2)
Pentasa
EXPERIMENTAL40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks
Align
ACTIVE COMPARATOR40 participants will be randomized to take Align tablets, once daily for 8 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AIDS Healthcare Foundationlead
- HIV Immunotherapeutics Institutecollaborator
Study Sites (1)
AIDS Healthcare Foundation - Public Health Division
Los Angeles, California, 90027, United States
Study Officials
- STUDY DIRECTOR
Otto O Yang, MD
AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
- PRINCIPAL INVESTIGATOR
Peter Anton, MD
AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2018
First Posted
January 17, 2018
Study Start
May 1, 2017
Primary Completion
March 22, 2019
Study Completion
March 22, 2019
Last Updated
March 4, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share