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

NCT05687565 | Unknown

• 1 other identifier: PR(AG)12/2022
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lauric acid; HIV; antiretroviral treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Effective 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

  48 weeks

• Effective of lauric acid on the size of the HIV-1 reservoir in intestinal tissue

  48 weeks

• Evaluate Lauric acid plasmatic levels

  48 weeks

Study Arms (3)

Control group

PLACEBO COMPARATOR

Dietary supplementation

Dietary Supplement: Control group placebo

Experimental group 1

EXPERIMENTAL

1.5 grams once daily during 48 weeks

Dietary Supplement: Experimental group 1 lauric acid

Experimental group 2

EXPERIMENTAL

3 grams once daily during 48 weeks

Dietary Supplement: Experimental group 2 lauric acid

Interventions

Control group placebo DIETARY_SUPPLEMENT

Dietary suplementation

Control group

Experimental group 1 lauric acid DIETARY_SUPPLEMENT

Lauric acid 1.5 grams once daily

Experimental group 1

Experimental group 2 lauric acid DIETARY_SUPPLEMENT

Lauric acid 3 grams once daily

Experimental group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitario Vall d´Hebron

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Joaquin Burgos, MD

CONTACT

93 4896090; joaquin.burgos@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 18, 2023
• Study Start: September 27, 2022
• Primary Completion: November 21, 2025
• Study Completion: December 21, 2025
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

ES (1)