Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2024-08-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Zinc Supplementation and Cardiovascular Risk in HIV

NCT02856269

HIV Inflammation

COMPLETED NA

Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

NCT00149552

HIV Infections Substance-Related Disorders

COMPLETED NA

Researching Alveolar Macrophage Improvements With Supplements in HIV

NCT02264860

HIV-1 Infection

COMPLETED NA

A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV

NCT05630885

HIV-1-infection Elevated Cardiovascular Risk

COMPLETED PHASE2

Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV

NCT02624180

Coronary Artery Disease Human Immunodeficiency Virus

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation Cardiovascular Diseases Zinc Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a double-blind randomized placebo-controlled trial 2:1 Patients will be given zinc gluconate capsules at a dose of 90 mg elemental zinc daily or matching placebo for 24 weeks.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Patients, study staff, and the study statistician will be blinded to treatment allocation (zinc gluconate or placebo capsules). The research staff as well as the principle investigator will remain blinded to treatment assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Zinc gluconate

Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.

Group Type EXPERIMENTAL

Zinc Gluconate

Intervention Type DRUG

Two 45 mg capsules once daily

Placebo

Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two placebo capsules once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zinc Gluconate

Two 45 mg capsules once daily

Intervention Type DRUG

Placebo

Two placebo capsules once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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