Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
NCT05687565 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2023-01-18
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
- 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
Sponsors & Collaborators
-
Hospital Universitari Vall d'Hebron Research Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-27
- Primary Completion
- 2025-11-21
- Completion
- 2025-12-21
Countries
- Spain
Study Locations
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