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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Dietary supplement: Control group placebo; Dietary supplement: Experimental group 1 lauric acid; Dietary supplement: Experimental group 2 lauric acid

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joaquin Burgos, MD; Phone Number: 93 4896090; Email: joaquin.burgos@vallhebron.cat

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall D´Hebron
    • Contact: Joaquin Burgos, MD; Phone Number: 93 4896090; Email: joaquin.burgos@vallhebron.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Dietary supplementation	Dietary supplement: Control group placebo; Dietary suplementation
Experimental: Experimental group 1; 1.5 grams once daily during 48 weeks	Dietary supplement: Experimental group 1 lauric acid; Lauric acid 1.5 grams once daily
Experimental: Experimental group 2; 3 grams once daily during 48 weeks	Dietary supplement: Experimental group 2 lauric acid; Lauric acid 3 grams once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Evaluate Lauric acid plasmatic levels	To evaluate Lauric acid with high performance liquid chromatography (HPLC).	48 weeks

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Anticipated): November 21, 2025
• Study Completion (Anticipated): December 21, 2025

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: HIV; antiretroviral treatment; lauric acid
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: PR(AG)12/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No