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

HIV Infections Clinical Trial

— FATHIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687565
• Other study ID #: PR(AG)12/2022
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2022
• Est. completion date: December 21, 2025

Study information

• Verified date: January 2023
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Joaquin Burgos, MD
• Phone: 93 4896090
• Email: joaquin.burgos[@]vallhebron.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 21, 2025
• Est. primary completion date: November 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• HIV-1 infected men or women =18 years old
• Not having interrupted current antiretroviral treatment at least 6 months before the screening visit.
• Acceptable stable ART regimens prior to screening include 2 more NRTIs: INI or NNRTI or boosted PI.
• Documented prior evidence of at least 2 years prior to enrollment with a serum HIV RNA load of <50 RNA copies/ml (viral load of >50 copies but <200 is allowed).
• Plasma HIV-1 RNA <50 c/ml at screening visit.
• CD4 T cell count > 300 cells/µL at screening visit.

A woman may be eligible to enroll and participate in the study if:

• Not pregnant, not of childbearing potential or physically unable to become pregnant
• You are of childbearing potential with a negative pregnancy test at the screening visit and agree to use contraception to prevent pregnancy.

Exclusion Criteria:

• Have suffered any significant acute illness in the last 8 weeks.
• Having been diagnosed in the past or present with an AIDS-defining illness
• Previous CD4 T cell count <200 cells/µL.
• Having suffered an infection with Hepatitis B or C
• Having any disease or condition that in the investigator's opinion is not appropriate for the patient's participation in the study.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Dietary Supplement:
• Control group placebo
Dietary suplementation
• Experimental group 1 lauric acid
Lauric acid 1.5 grams once daily
• Experimental group 2 lauric acid
Lauric acid 3 grams once daily

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall d´Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective of lauric acid in HIV	Number of patients on a lauric acid diet presenting a response on the reactivation of HIV transcription in CD4 T cells.	48 weeks
Secondary	Effective of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells	To dertermine the effetive of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells	48 weeks
Secondary	Effective of lauric acid on the production of HIV-1 viral	To dertermine the effetive of lauric acid on on the production of HIV-1 viral (viral load)	48 weeks
Secondary	Effective of lauric acid on the size of the HIV-1 reservoir in intestinal tissue	To dertermine the effetive of lauric acid on the size of the HIV-1 reservoir in intestinal tissue	48 weeks
Secondary	Evaluate Lauric acid plasmatic levels	To evaluate Lauric acid with high performance liquid chromatography (HPLC).	48 weeks