Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Early Phase 1

Completed

• Conditions: Inflammation; Zinc Deficiency; Cardiovascular Diseases
• Interventions: Drug: Placebo; Drug: Zinc Gluconate

• Registration Number: NCT05085834
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-07-02
• Study Start: 2020-01-22
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Status Verified: 2024-07
• Primary Completion: 2024-08-02
• Study Completion: 2024-08-02
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Zinc gluconate	Zinc Gluconate	Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Effect of zinc supplementation in HIV-infected subjects	baseline and 24 Weeks	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)

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States