Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Effective of lauric acid in HIV
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
Dietary supplementation
干预措施: Control group placebo (Dietary Supplement)
Experimental group 1
1.5 grams once daily during 48 weeks
干预措施: Experimental group 1 lauric acid (Dietary Supplement)
Experimental group 2
3 grams once daily during 48 weeks
干预措施: Experimental group 2 lauric acid (Dietary Supplement)
结局指标
主要结局
Effective of lauric acid in HIV
时间窗: 48 weeks
Number of patients on a lauric acid diet presenting a response on the reactivation of HIV transcription in CD4 T cells.
次要结局
- Effective 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(48 weeks)
- Effective of lauric acid on the size of the HIV-1 reservoir in intestinal tissue(48 weeks)
- Evaluate Lauric acid plasmatic levels(48 weeks)