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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 belowSelect...
I am infected with HIV-1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks
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
318 Previous Clinical Trials
339,992 Total Patients Enrolled
5 Trials studying Inflammation
164 Patients Enrolled for Inflammation
Case Western Reserve UniversityOTHER
300 Previous Clinical Trials
246,529 Total Patients Enrolled
1 Trials studying Inflammation
14 Patients Enrolled for Inflammation
Grace A McComsey, MD, FIDSAPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diabetes is not under control.I have a known heart condition.I am infected with HIV-1.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Zinc gluconate
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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