This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05687565
Recruitment Status : Recruiting
First Posted : January 18, 2023
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
HIV Infections Dietary Supplement: Control group placebo Dietary Supplement: Experimental group 1 lauric acid Dietary Supplement: Experimental group 2 lauric acid Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
Actual Study Start Date : September 27, 2022
Estimated Primary Completion Date : November 21, 2025
Estimated Study Completion Date : December 21, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Control group
Dietary supplementation
 Dietary Supplement: Control group placebo
Dietary suplementation
Experimental: Experimental group 1
1.5 grams once daily during 48 weeks
 Dietary Supplement: Experimental group 1 lauric acid
Lauric acid 1.5 grams once daily
Experimental: Experimental group 2
3 grams once daily during 48 weeks
 Dietary Supplement: Experimental group 2 lauric acid
Lauric acid 3 grams once daily


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Effective of lauric acid in HIV [ Time Frame: 48 weeks ]
    Number of patients on a lauric acid diet presenting a response on the reactivation of HIV transcription in CD4 T cells.


Secondary Outcome Measures :
  1. Effective of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells [ Time Frame: 48 weeks ]
    To dertermine the effetive of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells

  2. Effective of lauric acid on the production of HIV-1 viral [ Time Frame: 48 weeks ]
    To dertermine the effetive of lauric acid on on the production of HIV-1 viral (viral load)

  3. Effective of lauric acid on the size of the HIV-1 reservoir in intestinal tissue [ Time Frame: 48 weeks ]
    To dertermine the effetive of lauric acid on the size of the HIV-1 reservoir in intestinal tissue

  4. Evaluate Lauric acid plasmatic levels [ Time Frame: 48 weeks ]
    To evaluate Lauric acid with high performance liquid chromatography (HPLC).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05687565


Contacts
Layout table for location contacts
Contact: Joaquin Burgos, MD 93 4896090 joaquin.burgos@vallhebron.cat

Locations
Layout table for location information
Spain
Hospital Universitario Vall d´Hebron Recruiting
Barcelona, Spain, 08035
Contact: Joaquin Burgos, MD    93 4896090    joaquin.burgos@vallhebron.cat   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT05687565    
Other Study ID Numbers: PR(AG)12/2022
First Posted: January 18, 2023    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
lauric acid
HIV
antiretroviral treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
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