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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Dietary Supplement: Control group placebo
* Dietary Supplement: Experimental group 1 lauric acid
* Dietary Supplement: Experimental group 2 lauric acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Dietary supplementation | Dietary Supplement: Control group placebo<br>* Dietary suplementation<br>|
| Experimental: Experimental group 1<br>1.5 grams once daily during 48 weeks | Dietary Supplement: Experimental group 1 lauric acid<br>* Lauric acid 1.5 grams once daily<br>|
| Experimental: Experimental group 2<br>3 grams once daily during 48 weeks | Dietary Supplement: Experimental group 2 lauric acid<br>* Lauric acid 3 grams once daily<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lauric acid, HIV, antiretroviral treatment