Zn Supplementation in HIV Immunological Non Responders
Launched by PARC DE SALUT MAR · Sep 22, 2024
Trial Information
Current as of July 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether taking zinc supplements can help improve the immune system in people living with HIV who have not been able to restore their CD4 T-cell counts despite receiving treatment. CD4 T-cells are important for fighting infections, and those who are considered Immunological Non-Responders (INRs) face a higher risk of infections and other health issues. The trial will involve participants who are at least 18 years old, have confirmed HIV, and have low zinc levels. They must also be on stable HIV treatment for a certain period and have low CD4 counts.
Participants in this study will be randomly assigned to either receive a daily dose of 75 mg of zinc along with their usual treatment or to continue their treatment without the zinc supplement. The researchers will monitor changes in CD4 counts, inflammation levels, and overall immune system function throughout the trial. This study aims to find out if zinc can be a simple and effective way to improve health for people in this situation, potentially leading to better quality of life. It’s important to note that zinc supplementation is generally safe, but it should be taken under medical supervision.
Gender
ALL
Eligibility criteria
- 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
About Parc De Salut Mar
Parc de Salut Mar is a leading healthcare institution located in Barcelona, Spain, dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. As a prominent sponsor, it focuses on a wide range of therapeutic areas, emphasizing collaboration between multidisciplinary teams of healthcare professionals and researchers. The institution is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring the safety and well-being of participants while contributing to the development of cutting-edge treatments and therapies. With state-of-the-art facilities and a strong emphasis on patient-centered care, Parc de Salut Mar plays a vital role in the evolving landscape of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported