Using lauric acid to affect HIV reservoirs in patients
Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
This study is testing whether adding lauric acid to the diet can help people with HIV better control the virus while they are on treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05687565 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of dietary lauric acid supplementation on the latent HIV reservoir in patients undergoing stable antiretroviral therapy. Participants aged 18 and older with HIV-1 will be randomized into three groups: one receiving a placebo, one receiving 1.5 g of lauric acid daily, and another receiving 3 g daily for 24 weeks. The primary goal is to evaluate how lauric acid influences HIV transcription in latently infected CD4 T cells. The study aims to determine if lauric acid can enhance the immune response against HIV without causing toxicity.
Who should consider this trial
Good fit: Ideal candidates are HIV-1 infected adults aged 18 and older who have been on stable antiretroviral therapy for at least 6 months.
Not a fit: Patients with significant acute illnesses or those diagnosed with AIDS-defining illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of HIV by reducing the viral reservoir and enhancing immune response.
How similar studies have performed: While dietary interventions in HIV treatment are being explored, this specific approach using lauric acid is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barcelona
- Hospital Universitario Vall d´Hebron — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Joaquin Burgos, MD
- Email: joaquin.burgos@vallhebron.cat
- Phone: 93 4896090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.