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

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control group placebo
Experimental group 1 lauric acid
Experimental group 2 lauric acid
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring lauric acid, HIV, antiretroviral treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario Vall d´HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control group

Experimental group 1

Experimental group 2

Arm Description

Dietary supplementation

1.5 grams once daily during 48 weeks

3 grams once daily during 48 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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)
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
Evaluate Lauric acid plasmatic levels
To evaluate Lauric acid with high performance liquid chromatography (HPLC).

Full Information

First Posted
December 13, 2022
Last Updated
January 13, 2023
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05687565
Brief Title
Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
Acronym
FATHIV
Official Title
Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
November 21, 2025 (Anticipated)
Study Completion Date
December 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
lauric acid, HIV, antiretroviral treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Dietary supplementation
Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
1.5 grams once daily during 48 weeks
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
3 grams once daily during 48 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Control group placebo
Intervention Description
Dietary suplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental group 1 lauric acid
Intervention Description
Lauric acid 1.5 grams once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental group 2 lauric acid
Intervention Description
Lauric acid 3 grams once daily
Primary Outcome Measure Information:
Title
Effective of lauric acid in HIV
Description
Number of patients on a lauric acid diet presenting a response on the reactivation of HIV transcription in CD4 T cells.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Effective of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells
Description
To dertermine the effetive of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells
Time Frame
48 weeks
Title
Effective of lauric acid on the production of HIV-1 viral
Description
To dertermine the effetive of lauric acid on on the production of HIV-1 viral (viral load)
Time Frame
48 weeks
Title
Effective of lauric acid on the size of the HIV-1 reservoir in intestinal tissue
Description
To dertermine the effetive of lauric acid on the size of the HIV-1 reservoir in intestinal tissue
Time Frame
48 weeks
Title
Evaluate Lauric acid plasmatic levels
Description
To evaluate Lauric acid with high performance liquid chromatography (HPLC).
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joaquin Burgos, MD
Phone
93 4896090
Email
joaquin.burgos@vallhebron.cat
Facility Information:
Facility Name
Hospital Universitario Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquin Burgos, MD
Phone
93 4896090
Email
joaquin.burgos@vallhebron.cat

12. IPD Sharing Statement

Learn more about this trial

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

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