An interventional study of Control group placebo and Experimental group 1 lauric acid in HIV Infections, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 27 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A woman may be eligible to enroll and participate in the study if:
Exclusion Criteria:
Dietary supplementation
Dietary Supplement: Control group placebo
1.5 grams once daily during 48 weeks
Dietary Supplement: Experimental group 1 lauric acid
3 grams once daily during 48 weeks
Dietary Supplement: Experimental group 2 lauric acid
Dietary suplementation
Lauric acid 1.5 grams once daily
Lauric acid 3 grams once daily
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.
Time frame: 48 weeks
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
Time frame: 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)
Time frame: 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
Time frame: 48 weeks
Evaluate Lauric acid plasmatic levels
To evaluate Lauric acid with high performance liquid chromatography (HPLC).
Time frame: 48 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitari Vall d'Hebron Research Institute