Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
NCT ID: NCT05687565
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
27 participants
INTERVENTIONAL
2022-09-27
2025-12-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Dietary supplementation
Control group placebo
Dietary suplementation
Experimental group 1
1.5 grams once daily during 48 weeks
Experimental group 1 lauric acid
Lauric acid 1.5 grams once daily
Experimental group 2
3 grams once daily during 48 weeks
Experimental group 2 lauric acid
Lauric acid 3 grams once daily
Interventions
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Control group placebo
Dietary suplementation
Experimental group 1 lauric acid
Lauric acid 1.5 grams once daily
Experimental group 2 lauric acid
Lauric acid 3 grams once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Hospital Universitario Vall d´Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR(AG)12/2022
Identifier Type: -
Identifier Source: org_study_id
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