Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Cardiovascular Diseases Clinical Trial

Official title:

Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05085834
• Other study ID #: Zinc study
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 22, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: Grace A McComsey, MD, FIDSA
• Phone: 216-844-2739
• Email: Grace.McComsey[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy

Description:

This study will focus on subjects with documented zinc deficiency (levels <75 µg/dl) as group most likely to benefit from the zinc supplementation. The investigators also acknowledge that zinc may be beneficial in all HIV subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV-1 infection

• Documentation of an HIV-1 RNA level of =400 copies/mL in the last 4 months prior to study entry

• Male or Female age =18 years

• Zinc level =0.75 mg/L in the last 60 days

Exclusion Criteria:

• Pregnancy/lactation

• Known cardiovascular disease

• Uncontrolled diabetes

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Inflammation
• Zinc Deficiency

Intervention

Drug:
• Zinc Gluconate
Two 45 mg capsules once daily
• Placebo
Two placebo capsules once daily

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of zinc supplementation in HIV-infected subjects	Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency	baseline and 24 weeks
Primary	Effect of zinc supplementation in HIV-infected subjects	Changes in markers of inflammation and immune activation by measuring momonocyte activation soluble markers CD14 (sCD14), high sensitivity C reactive protein (hsCRP), and soluble tumor necrosis alpha receptor I and II (sTNFR-I and II)	baseline and 24 Weeks