RANDOMIZED TREATMENT STUDY WITH EMTRICITABIN / TENOFOVIR DF AND LOPINAVIR / RITONAVIR COMPARED WITH A NO THERAPY REGIME IN PARTICIPANTS RECENTLY INFECTED WITH HIV-1 TO DETERMINE IF POWERFUL ANTIRETROVIRAL THERAPY ALTERS THE VIROLOGICAL SETPOINT

Division de SIDA de los Institutos Nacionales de Salud (USA),0 个研究点目标入组 0 人开始时间: 2008年5月9日最近更新: 2023年9月4日

试验速览

阶段: 未知
状态: 已完成
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 0 至 0（—）

入选标准

•Early infection with HIV-1, which is defined as an HIV-1 positive EIA and a positive Western blot, both obtained within 21 days prior to study entry
•No exposure to previous antiretroviral therapy, although the administration of post-exposure prophylaxis with antiretrovirals more than a year before entry into the study will be allowed.
•A CD4 + T cell count> 350 cells / mm3 obtained within 21 days prior to entry into the study in any laboratory that is CLIA certified or equivalent or that participates in the UKNEQAS (National External Quality Safety Service of the United Kingdom). United Kingdom National External Quality Assurance Service in English).
•One RNA of HIV-1 s500 copies / mL obtained within 21 days prior to study entry by any laboratory that is OLIA certified or its equivalent.
•Laboratory values obtained within a period of 21 days before entering the Study within normal values
•Men and women> 18 years of age.
•Ability and willingness to provide written informed consent.
•Women volunteers in the study with reproductive capacity (this is defined as women who have reached menarche or women who have not been postmenopausal for at least 24 consecutive months, that is, who have had menstruation within the previous 24 months, or who have not undergone surgical sterilization (such as a hysterectomy, bilateral oophorectomy, or salpingotomy) must have a serum or urine negative pregnancy test within 21 days before entering the study.
•If you participate in an activity that could lead to pregnancy, the woman volunteer should use at least one of the following forms of birth control during the entire time of participation in the protocol and for 6 weeks after she has stopped taking them. medicines

排除标准

•Progress of HIV infection to Category B or 0 disease according to the CDG. Note that the symptoms that are attributed to acute seroconversion disease are not mutually exclusive. Note that the percentage of CD4 + T lymphocytes of the total lymphocytes <14% is exclusion because it constitutes category 0 according to the CDG.
•Pregnancy or breastfeeding.
•History of pancreatitis.
•Use within 211 days before admission to the study of drugs that are highly dependent on CYP3A for their purification and for which, plasma concentrations are associated with adverse events that compromise life as astemizole, cisapride, alkaloids ergot and derivatives, flecainide, St. John´s wort, lovastatin, midazolam. pimozide, propafenone, rifampin, simvastatin, terfenadine, trlazolam. Check the insert of the most recent LPV / RTV package to find the other exclusive medications.
•Have received an investigational anti-HIV vaccine.
•Current therapy with any of the following medications: 1. Systemic corticosteroids. A short course of less than 21 days of corticosteroids is allowed. 2. Systemic chemotherapeutic agents 3. Systemic nephrotoxic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine 4. Treatment with immunomodulators, including lnterlukin-2 5. Agents under investigation
•Allergy / sensitivity or any known hypersensitivity to study drug components or their formulas,
•Active use of drugs or alcohol or dependency that. In the opinion of the investigator of the research center, it could interfere with compliance with the requirements of the study.
•Severe medical or psychiatric illness that, in the opinion of the researcher of the research center, could interfere with the ability to comply with the requirements of the study.
•Hepatitis B positive surface antigen within 21 days before entering the study.

研究者

发起方

Division de SIDA de los Institutos Nacionales de Salud (USA),

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