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Micronutrient

Zinc Supplementation for HIV

Phase < 1
Recruiting
Led By Grace A McComsey, MD, FIDSA
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV-1 infection
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 weeks
Awards & highlights

Study Summary

This trial will investigate whether zinc supplementation can help improve outcomes for HIV patients who are taking antiretroviral therapy.

Who is the study for?
This trial is for adults over 18 with HIV-1, who have had a stable viral load of ≤400 copies/mL in the past 4 months and are on steady anti-retroviral therapy. They must also have low zinc levels (≤0.75 mg/L) recently. Pregnant or breastfeeding individuals, those with known heart disease, or uncontrolled diabetes cannot participate.Check my eligibility
What is being tested?
The study is testing if taking zinc gluconate supplements can reduce inflammation and lower the risk of heart problems in people with HIV compared to a placebo (a pill without active medicine). Participants will be randomly assigned to either receive zinc gluconate or a placebo.See study design
What are the potential side effects?
Zinc supplementation may cause nausea, vomiting, diarrhea, metallic taste in mouth, kidney and stomach damage if taken in high doses. However, side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am infected with HIV-1.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of zinc supplementation in HIV-infected subjects

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Zinc gluconateExperimental Treatment1 Intervention
Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zinc Gluconate
2012
N/A
~290

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,261 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
260,001 Total Patients Enrolled
Grace A McComsey, MD, FIDSAPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

Zinc Gluconate (Micronutrient) Clinical Trial Eligibility Overview. Trial Name: NCT05085834 — Phase < 1
Cardiovascular Disease Research Study Groups: Zinc gluconate, Placebo
Cardiovascular Disease Clinical Trial 2023: Zinc Gluconate Highlights & Side Effects. Trial Name: NCT05085834 — Phase < 1
Zinc Gluconate (Micronutrient) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05085834 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Jun 2024