RPCEC00000134已完成4 期
Effectiveness and safety of tenofovir + lamivudine + efavirenz generic scheme for the treatment of HIV infection / AIDS in patients of the Corporacion de lucha contra el Sida, Santiago de Cali-Colombia, 2012-2013.
Corporación de Lucha Contra el Sida0 个研究点目标入组 80 人开始时间: 2012年7月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •1) Outpatient adults (> 18 years), who agree to participate through informed consent, in the Program for Comprehensive Care Specialized Ambulatory of Corporación de Lucha contra el Sida diagnosed as HIV +, by laboratory testing (presumptive tests and confirmatory test, count of CD4 cells and percentage by flow cytometry and viral load values by virus copies/mL with PCR assay in reverse transcriptase real-time.
- •2) With the result of negative resistance genotypic study (analyzed and interpreted under the most current recommendations for the management of HIV infection in the world), and/or without clinical/epidemiological evidence of any possible effects of the susceptibility of the drugs under study.
- •3) Patients without past or present renal disease
- •4) Patients without prior exposure to ARVs, or with previous exposure to ARV first line (2 NRTIs + 1 NNRTI + Boosted PI) successful (maximum constant viral suppression), without therapeutic failure but with the appearance of a side or undesirable effects attributable(s) primarily to NRTIs used (such as severe gastrointestinal intolerance, blood disorders, lipid and cardiovascular risk changes, lipoatrophy, lactic acidosis, risk or occurrence of hypersensitivity reactions, etc.).
- •5) That clinically and by guides(2011-2012) of the Corporación de Lucha contra el Sida and supported by the latest recommendations for the initiation of such treatment in the world that they are willing to comply with this ARV treatment and they don't start it o receive previously.
排除标准
- •1) Patients with renal failure (serum creatinine equivalent to an estimated creatinine clearance less than 60 mL/ minute). Patients with serum creatinine greater than 1.5 mg%. 2) Patients with liver failure associated with primary or other disease. 3) women who are pregnant or lactating, or of childbearing age without contraception permanent or safer method. 4) Patients who are using drugs or require a high probability of clinically relevant interactions (such as Rifampicin, Itraconazole, etc.). 5) Patients hospitalized. 6) Patients with major psychiatric disorders. 7) Patients with a history and / or substance abuse problems not intervened. 8) Patients with variable work schedules that include night shifts.
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