Zinc supplements for people with HIV who haven't regained CD4 counts
Role of Zinc Supplementation in Immunological Non-responders HIV Individuals: Exploring Pathways for Persistent Inflammation
This trial will try zinc supplements to help adults with HIV who remain with low CD4 counts despite effective ART.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Parc de Salut Mar Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06612554 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.