Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687565
Status:
RECRUITING
Last Update Posted:
2023-01-18
First Post:
2022-12-13
Brief Title:
Efficacy of Lauric Acid a Dietary Fatty Acid in Modifying the Latent Reservoir of HIV
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Efficacy of Lauric Acid a Dietary Fatty Acid in Modifying the Latent Reservoir of HIV
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FATHIV
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 copiesmL for at least 2 years and with a CD4 T cell count 300 cellsĪ¼l will be randomized 111 to dietary supplementation with placebo controlled group or lauric acid 15 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
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 copiesmL for at least 2 years and with a CD4 T cell count 300 cellsĪ¼l will be randomized 111 to dietary supplementation with placebo controlled group or lauric acid 15 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None