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Zn Supplementation in HIV Immunological Non Responders

RecruitingNAAges 18 Years - anyAllParc de Salut Mar
NCT06612554 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Zinc is an essential micronutrient crucial for the normal functioning of the human immune system. Zinc deficiency impairs immune function and increases infection risk, especially in vulnerable populations like people living with HIV. This project aims to study the role of zinc supplementation in improving immune response in HIV-infected individuals who are Immunological Non-Responders (INRs)-people who have not restored Cluster of differentiation 4 (CD4) T-cell counts despite receiving antiretroviral therapy (ART). INRs face a higher risk of opportunistic infections, non-HIV comorbidities due to high inflammation, and generally have a poorer prognosis. Zinc supports immune function by aiding in immune cell development, cytokine production, and maintaining mucosal barrier integrity. Several studies have investigated zinc supplementation in HIV-infected individuals, showing significant in

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📋 Eligibility rules (as published)
Inclusion Criteria: * confirmed HIV infection; * 18 years or older * Serum zinc levels less than 150ug/dl (normal range considered 75-150 ug/dl) * HIV-1 infection on stable ART for at least 3 months with cumulative ART duration of at least 6 months * Undetectable (less than 50copies/ml) persistently (isolated transient increases in viremia of less than 1000 copies/ml will be accepted) * Persistent less than 500CD4+ T-cells/mm3 at enrolment or an increase of less than 80 cells/mm3 after one year of viral undetectability Exclusion Criteria: * Pregnancy * Lactation * Active infectious or inflammatory condition * Uncontrolled diabetes * Serum Zinc levels more than 150ug/dl
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What it tests

  • zinc acetate
  • Placebo
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Where

1 site
Hospital del Mar
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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