Clinical trial NCT05687565: Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
Official title: Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: lauric acid
HIV
antiretroviral treatment
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effective of lauric acid in HIV
timeFrame: 48 weeks
Secondary outcomes:
measure: Effective of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells
timeFrame: 48 weeks
measure: Effective of lauric acid on the production of HIV-1 viral
timeFrame: 48 weeks
measure: Effective of lauric acid on the size of the HIV-1 reservoir in intestinal tissue
timeFrame: 48 weeks
measure: Evaluate Lauric acid plasmatic levels
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebron
Study officials:
References: