NCT03399903

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: AIDS Healthcare Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV-1-infection
• Gut Inflammation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-03-22
• Completion: 2019-03-22
• First posted: 2018-01-17
• Last updated: 2020-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study