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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399903
• Other study ID #: HII-03
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 1, 2017
• Est. completion date: March 22, 2019

Study information

• Verified date: March 2020
• Source: AIDS Healthcare Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Gut Inflammation
• HIV Infections
• HIV-1-infection
• Infection
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
United States	AIDS Healthcare Foundation - Public Health Division	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Healthcare Foundation	HIV Immunotherapeutics Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation markers	C-reactive protein	14 weeks
Secondary	Flow cytometry for cellular immune activation	Immune activation	14 weeks
Secondary	Plasma markers of microbial translocation	Microbial translocation	14 weeks