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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Dietary supplementation |
|
| Experimental group 1 | Experimental | 1.5 grams once daily during 48 weeks |
|
| Experimental group 2 | Experimental | 3 grams once daily during 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group placebo | Dietary Supplement | Dietary suplementation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 weeks |
| Effective of lauric acid on the production of HIV-1 viral |
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Inclusion Criteria:
A woman may be eligible to enroll and participate in the study if:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joaquin Burgos, MD | Contact | 93 4896090 | joaquin.burgos@vallhebron.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Vall d´Hebron | Recruiting | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Experimental group 1 lauric acid |
| Dietary Supplement |
Lauric acid 1.5 grams once daily |
|
| Experimental group 2 lauric acid | Dietary Supplement | Lauric acid 3 grams once daily |
|
To dertermine the effetive of lauric acid on on the production of HIV-1 viral (viral load)
| 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 | 48 weeks |
| Evaluate Lauric acid plasmatic levels | To evaluate Lauric acid with high performance liquid chromatography (HPLC). | 48 weeks |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |