NCT05687565

Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Dietary lauric acid supplementation could have a significant impact on the HIV reservoir in antiretroviral-treated patients by inducing HIV viral transcription in latently infected cells and preserving the HIV-specific immune response, without causing toxicity. Design: Pilot, randomized, placebo-controlled, patient-blind study. Patients ≥18 years old with HIV-1 receiving stable ART (no change in ART for at least 6 months) and a serum HIV RNA load of \< 50 RNA copies/mL for at least 2 years and with a CD4 T cell count \>300 cells/μl will be randomized 1:1:1 to dietary supplementation with placebo (controlled group) or lauric acid 1.5 g once daily (experimental group 1) or with lauric acid 3 g once daily (experimental group 2) for 24 consecutive weeks. Primary objective: To assess the effect of dietary lauric acid supplementation, compared with placebo, on the reactivation of HIV transcription in latently infected CD4 T cells in HIV-infected patients on suppressive antiretroviral therapy.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Control group placebo	Dietary suplementation
DIETARY_SUPPLEMENT	Experimental group 1 lauric acid	Lauric acid 1.5 grams once daily
DIETARY_SUPPLEMENT	Experimental group 2 lauric acid	Lauric acid 3 grams once daily

Timeline

• Start date: 2022-09-27
• Primary completion: 2025-11-21
• Completion: 2025-12-21
• First posted: 2023-01-18
• Last updated: 2023-01-18

Locations

1 site across 1 country: Spain