Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
- Conditions
- HIV Infections
- Interventions
- Dietary Supplement: Experimental group 2 lauric acidDietary Supplement: Control group placeboDietary Supplement: Experimental group 1 lauric acid
- Registration Number
- NCT05687565
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 27
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group 2 Experimental group 2 lauric acid 3 grams once daily during 48 weeks Control group Control group placebo Dietary supplementation Experimental group 1 Experimental group 1 lauric acid 1.5 grams once daily during 48 weeks
- Primary Outcome Measures
Name Time Method Effective of lauric acid in HIV 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
Name Time Method Effective of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells 48 weeks 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 48 weeks 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 48 weeks To dertermine the effetive of lauric acid on the size of the HIV-1 reservoir in intestinal tissue
Evaluate Lauric acid plasmatic levels 48 weeks To evaluate Lauric acid with high performance liquid chromatography (HPLC).
Trial Locations
- Locations (1)
Hospital Universitario Vall d´Hebron
🇪🇸Barcelona, Spain