HIV Infections
Conditions
Keywords
lauric acid, HIV, antiretroviral treatment
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.
Interventions
DIETARY_SUPPLEMENTControl group placebo
Dietary suplementation
DIETARY_SUPPLEMENTExperimental group 1 lauric acid
Lauric acid 1.5 grams once daily
DIETARY_SUPPLEMENTExperimental group 2 lauric acid
Lauric acid 3 grams once daily
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Spain
Contacts
Primary ContactJoaquin Burgos, MD
Outcome results
None listed