PER-024-99已完成未知
A RANDOMIZED, OPEN-LABEL SUPERIORITY TRIAL COMPARATIVE BETWEEN EMTRICITABINE AND ABACAVIR USED IN A THREE-DRUG COMBINATION IN HIV-INFECTED PATIENTS WHO HAVE NEVER TAKEN ANTI-HIV
IVERSIDAD PERUANA CAYETANO HEREDIA,0 个研究点目标入组 0 人开始时间: 1999年12月20日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •a) Patients of both sexes,> 18 years with good health at the time of the screening visit.
- •b) HIV-1 RNA levels higher or equivalent to 5,000 copies / mL recorded at the screening visit.
- •c) CD4 + count> 200 cells / mm3.
- •d) treatment-naïve patients (within 3 days antiretroviral therapy).
- •e) Informed consent.
- •f) Women of reproductive age with negative serum analysis of human chorionic gonadotropin (p-HCG) within 14 days prior to the first dose of the medication. (The effects of Emtricitabine on the fetus are unknown, but malformations have been observed in fetuses of animals treated with Efavirenz).
排除标准
- •a) Consumption of alcohol or narcotics that, according to the principal investigator, would hinder the monitoring of the doses and evaluations of the protocol.
- •b) Pregnant or lactating women. (The consequences of the infant´s exposure to Emtricitabine are unknown).
- •c) Women of reproductive age who do not use effective barrier contraceptive methods during the study.
- •d) Clinical or laboratory abnormalities> Grade 3 toxicity, except for the following laboratory parameters, manifested in the screening visit and specified in the exclusion criteria:
- •Hemoglobin <9.2 g / deciliter (di) for men and <8, .8 g / dl for women (without blood transfusion or erythrocytes within 21 days prior to analysis).
- •Neutrophil count <1000 cells / mm3.
- •Platelet count <75,000 cells / mm3.
- •Aspartate-amino-transferase (AST) or alanine-amino-transferase (ALT)> 5 times the normal upper value (ULN.)
- •Serum creatinine> 1.6 times ULN.
- •serum amylase> 2.0 times the ULN (pancreatic portion). Normal pancreatic lipase or amylase levels are required if the total amylase is> 2.0 times the ULN.
- •Total bilirubin> 1.6 mg / dl.
- •e) Peripheral neuropathy> Grade 2 or significant antecedents.
- •f) Malabsorption or chronic diarrhea (> Grade 2) within 30 days before the study or inability to eat properly (> 1 meal (s) per day) due to chronic nausea, emesis, or upset stomach or esophagus.
- •g) Acute or severe medical event within 30 days of the screening visit. Acute treatment should be completed 14 days before the start of the study.
- •h) Previous opportunistic AIDS infections, except pulmonary tuberculosis or gastrointestinal infection.
- •i) Patients currently under treatment against active tuberculosis.
- •j) Patients who require treatment or chronic prophylaxis with sulfa drugs.
- •k) Patients using derivatives of astemizole, cisapride, midazolam, triazolam or ergotamine.
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