Zinc Supplementation and Cardiovascular Risk in HIV

Study Overview
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Brief Summary
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The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.

Detailed Description
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Zinc is a dietary supplement with compelling preclinical evidence for potential health benefit that could be expanded not only to the entire HIV population, but also to other inflammatory conditions that share many facets of HIV infection, namely the persistent intestinal barrier dysfunction, monocyte activation and heightened inflammation state.

Official Title
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Zinc Supplementation and Cardiovascular Risk in HIV

Conditions
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HIV, Inflammation

Intervention / Treatment
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* Dietary Supplement: Zinc gluconate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 infection Age ≥18 years Zinc level ≤0.75 mg/L Receiving a stable antiretroviral regimen with no plans to change during study Documentation of an HIV-1 RNA level of ≤400 copies/mL No diarrhea or nausea/vomiting for the last month Exclusion Criteria: Pregnancy/lactation Presence of inflammatory condition Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study. Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs Known cardiovascular disease Uncontrolled diabetes Allergy or intolerance to zinc sulfate. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x Upper limit of normal (ULN) Hemoglobin < 9.0 g/dL glomerular filtration rate (GFR) < 50 mL/min

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pilot open labeled randomized double arm trial, studying zinc supplementation to prevent HIV comorbidities that are linked to inflammation. Patients will be given zinc gluconate 45 mg capsule once daily in one arm, and 90 mg zinc gluconate in the other arm for 16 weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 45 mg daily<br>Participants in this arm will take a daily 45 mg dose of zinc gluconate. | Dietary Supplement: Zinc gluconate<br>* Participants will take a daily dose of zinc gluconate.<br>|
| Active Comparator: 90 mg daily<br>Participants in this arm will take a daily 90 mg dose of zinc gluconate. | Dietary Supplement: Zinc gluconate<br>* Participants will take a daily dose of zinc gluconate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | Percentage of participants with the following inflammatory markers decrease (sCD14) Soluble cluster of differentiation 14, (sTNF-RI) soluble Tumor Necrosis Factor alpha receptor I, (hs-CRP) High sensitivity C-reactive protein. These inflammatory markers are measured in the blood by enzyme-linked immunoassay ELISA. | Baseline and 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants That Reached the Zinc Sufficient Level After Treatment | After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels >75 μg/dL. | 16 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc