Zinc supplements for people with HIV who haven't regained CD4 counts
Official title: Role of Zinc Supplementation in Immunological Non-responders HIV Individuals: Exploring Pathways for Persistent Inflammation
Run by Parc de Salut Mar · NCT06612554 · Data updated 2026-11-12
This trial will try zinc supplements to help adults with HIV who remain with low CD4 counts despite effective ART.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Parc de Salut Mar Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | January 2, 2025 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT06612554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with confirmed HIV-1 on stable ART, persistently undetectable viral load, serum zinc <150 µg/dL, and persistently <500 CD4+ cells/µL or <80 cell rise after one year of viral suppression are ideal candidates.
✕Probably not a fit
People who are pregnant or lactating, have active infections, uncontrolled diabetes, serum zinc above 150 µg/dL, or who already have adequate CD4 recovery are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with HIV who meet criteria for immunological non-response and have serum zinc below 150 µg/dL will be enrolled and receive either zinc acetate or a matching placebo. Participants will remain on their regular antiretroviral therapy while investigators monitor CD4 counts, markers of immune activation and inflammation, and safety over the treatment period. The trial targets people who are virally suppressed but have persistent CD4 counts under 500 cells/µL or minimal CD4 gain after viral suppression. Outcomes will compare immune recovery and inflammatory markers between the zinc and placebo groups.
Why it matters
Potential benefit: If successful, zinc supplementation could increase CD4 counts, reduce inflammation, and lower the risk of opportunistic and non-HIV comorbidities in immunological non-responders.
How similar studies have gone: Previous studies in people with HIV have reported increased CD4 counts and fewer opportunistic infections with zinc supplementation, but dosing and populations varied so results remain promising but not definitive.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospital del Mar
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Robert C Güerri-Fernández, M.D. Ph.D.
- Email: rguerri@hmar.org
- Phone: +34 932483246
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AWARE.HIV Europe: supporting hospital teams to find undiagnosed HIV across Europe
This project will test whether putting dedicated HIV teams into hospitals increases HIV testing for people who come in with conditions that could suggest HIV across ten European countries.
-
Evaluating Codivir® with standard HIV treatment for newly diagnosed patients
This study is testing if adding a new drug called Codivir® to standard HIV treatment can help newly diagnosed patients have better health outcomes.
-
Project SHIELD 2.0: Police Education to Support Public Health in Kentucky
Aimed at police in Kentucky, this program tests whether SHIELD training given to officers, with health workers helping deliver it, can reduce drug-related arrests and steer people who use drugs toward MOUD and other health services.
-
New ways to diagnose lymphoma and multicentric Castleman disease in people living with HIV
This study tests a quick, point-of-care nucleic acid test to help diagnose lymphoma and multicentric Castleman disease in people living with HIV in sub-Saharan Africa.
-
Expanding HIV-positive donor livers for HIV-positive recipients
This study tests whether liver transplants from HIV-positive donors to HIV-positive recipients are safe regarding opportunistic infections and cancer.
-
Bridge to Belonging: A Peer‑Led Program to Reduce Loneliness and Depression in older gay and bisexual men with HIV
This program tests a peer-delivered, manualized approach to help men aged 50+ with HIV connect to LGBTQ+-affirming elder services to see if it reduces loneliness and depressive symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.