EUCTR2016-002006-39-IT进行中（未招募）1 期
Study on Efficacy and safety of an early proactive Switch To ElvitegraviR/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in patients with a primary HIV-1 infection - ESTER
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI0 个研究点目标入组 30 人开始时间: 2021年6月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age>18 years
- •Diagnosis of HIV-1 infection during PHI as determined by at least one of the following criteria: a) positive HIV viral load (2000 copies/mL) and negative HIV Ab/Ag Combo or Western Blot test, b) positive HIV Ab/Ag Combo test and negative or undetermined Western Blot test; c) positive HIV Ab/Ag Combo test and incomplete Western Blot test (no p31 protein reactivity); d) recent infection confirmed by a positive HIV-1 EIA or Western Blot test and a documented negative HIV-1 EIA within the previous 6 months
- •Being on first-line treatment of primary HIV-1 infection with either DRV/RTV or DRV/C +TDF/FTC + RAL treatment; minimum time on treatment is the time elapsed between start of ARV and first available HIV RNA <40 copies/ml
- •Plasma HIV-1 RNA <40 copies/mL at least one HIV RNA test
- •To have Genotyping Resistance Test before start of ARV without resistance mutations to any antiretroviral drug class
- •A female subject is eligible to enter the study if it is confirmed that she is:
- •-Not pregnant confirmed by a negative serum pregnancy test
- •-Not breastfeeding
- •-Of non-childbearing potential (eg women who have had a hysterectomy or both ovaries removed or are postmenopausal women >54years of age with cessation for >12 months of previously occurring menses)
- •-Of childbearing potential (as defined in Appendix **) and agrees to utilize the protocol specified method of contraception or be non-heterosexually active or practice sexual abstinence (as defined in Appendix **) from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs.
- •-Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
- •Written Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Exclusion criteria
- •Presence of an opportunistic infection or an AIDS-defining illness, unless they are directly attributable to the acute seroconversion illness
- •Receipt of investigational research agents within 30 days prior to study entry
- •Receipt of prior experimental HIV vaccines. Individuals who received a saline placebo in a prior HIV vaccine trial are not excluded, provided that they did not receive a sham vector or an adjuvant.
- •Receipt of immunosuppressive medications or immune-modulators (e.g., cytokine therapy) within the past 6 months.
- •Current anti-tuberculosis prophylaxis or therapy
- •Serious illness other than acute HIV infection requiring systemic treatment or hospitalization until either therapy is completed or patient is clinically stable on therapy
- •Hepatitis C (HCV Ab positive) or hepatitis B infection (Positive hepatitis B surface antigen, HBsAg)
- •Women who are pregnant or breastfeeding
- •Renal function with CrCl below 50 mL/min
- •Severe hepatic impairment
- •Known hypersensitivity to the study drug, the metabolites or formulation excipients.
研究者
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