Early Phase 1 N=95 Randomized Quadruple-blind Prevention

Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Inflammation · Cardiovascular Diseases · Zinc Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT05085834 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Jun 2025

Primary outcome: Primary: Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects — 8.60; 33.50 absolute change (μg/dL) — p=<0.01

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Zinc Gluconate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospitals Cleveland Medical Center
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects	8.60; 33.50	<0.01 sig
PRIMARY Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects	-22.86; 1.33; 101.71; -56.31; -50.11; 43.69	1.00
PRIMARY Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects	-25.08; 1.27; -121.65; 99.33; -0.47; -0.02	0.55
PRIMARY Effect of Zinc on oxLDL in HIV-infected Subjects	20833.33; 8639.79	0.83
SECONDARY Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects	3.10; 1.35; -1.70; -2.45; 6.00; -1.50	0.84
SECONDARY Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects	0.10; 0.10	0.36
SECONDARY the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects	0.28; 0.10	0.86
SECONDARY Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects	0.50; 1.67	0.74
SECONDARY Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects	2.20; 0.00	0.81
SECONDARY Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-	6.00; 0.00; 3.00; 0.00	0.41
SECONDARY Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects	0.40; 0.00	0.70
SECONDARY Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects	-0.34; -0.18; 0.00; -1.00	0.62
SECONDARY Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects	100.82; 58.89; -28.19; 8.36	0.90
SECONDARY Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects	0.47; 0.72; 78.2; 270.54	0.69

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05085834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.