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

Vall d'Hebron University Hospital (HUVH)

Status: Enrolling

Conditions: HIV Infections

Treatments: Dietary Supplement: Control group placebo; Dietary Supplement: Experimental group 1 lauric acid; Dietary Supplement: Experimental group 2 lauric acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05687565

PR(AG)12/2022

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Dietary supplementation

Treatment:

Dietary Supplement: Control group placebo

Experimental group 1

Experimental group

Description:

1.5 grams once daily during 48 weeks

Treatment:

Dietary Supplement: Experimental group 1 lauric acid

Experimental group 2

Experimental group

Description:

3 grams once daily during 48 weeks

Treatment:

Dietary Supplement: Experimental group 2 lauric acid