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| Name | Class |
|---|---|
| HIV Immunotherapeutics Institute | OTHER |
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An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentasa | Experimental | 40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks |
|
| Align | Active Comparator | 40 participants will be randomized to take Align tablets, once daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentasa vs Align | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation markers | C-reactive protein | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Flow cytometry for cellular immune activation | Immune activation | 14 weeks |
| Plasma markers of microbial translocation | Microbial translocation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Otto O Yang, MD | AIDS Healthcare Foundation - HIV Immunotherapeutics Institute | Study Director |
| Peter Anton, MD | AIDS Healthcare Foundation - HIV Immunotherapeutics Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDS Healthcare Foundation - Public Health Division | Los Angeles | California | 90027 | United States |
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| 14 weeks |