EUCTR2004-005083-25-GB进行中（未招募）不适用
A Phase IV, Randomized, Double-Blind, Placebo-Controlled Two-Phase Crossover Study of the Metabolic Impact of Tenofovir Disoproxil Fumarate on HIV 1 Seronegative Healthy Adult Males
Gilead Sciences Incorporated0 个研究点开始时间: 2005年3月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •Subjects must have documented negative HIV serology by ELISA and P24 antigen. This will be done at the screening visit.
- •Subjects must be clinically well males aged between 18 to 55 years.
- •Adequate renal function (calculated creatinine clearance (CrCl) = 100 mL/min)
- •Fasting blood glucose, total cholesterol and triglycerides within normal limits
- •Hepatic transaminases (AST and ALT) = 3 x upper limit of normal (ULN)
- •Total bilirubin = 1.5 mg/dL
- •Adequate hematologic function (absolute neutrophil count = 1,000/mm3; platelets = 50,000/mm3; hemoglobin =8.0 g/dL)
- •Serum amylase = 1.5 x ULN (subjects with serum amylase > 1.5 x ULN will remain eligible if pancreatic lipase is less than or equal to 1.5 x ULN)
- •Serum phosphorus = 2.2 mg/dL
- •Sexually active males must use condoms
- •Life expectancy = 1 year
- •The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded
- •Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
- •Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
- •Other metabolic syndrome or disease process likely to cause marked disturbance in glucose and lipid homeostasis
- •Receiving on-going therapy with any of the following:
- •Metabolically active medications
- •Any lipid-lowering medication
- •Hormonal agents (oestrogens or androgens)
- •Glucocorticoids
- •Beta-blockers
- •Thiazide diuretics
- •Thyroid preparations
- •Psychotropic agents
- •Anabolic steroids
- •Megoestrol acetate
- •Nephrotoxic agents
- •aminoglycoside antibiotics
- •IV amphotericin B
- •cidofovir
- •cisplatin
- •foscarnet
- •IV pentamidine
- •other agents with significant nephrotoxic potential
- •Vancomycin
- •Oral or IV ganciclovir
- •Agents that inhibit or compete for elimination via active renal tubular secretion
- •Probenecid
- •Systemic chemotherapeutic agents (i.e., cancer treatment medications)
- •Systemic corticosteroids
- •Interleukin 2 (IL 2) and other immunomodulating agents
- •Investigational agents
- •Administration of any of the above medications must be discontinued at least 30 days prior to the baseline visit and for the duration of the study period.
- •Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
- •Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance.
- •Malignancy or basal cell carcinoma.
- •Active, serious infections requiring parenteral antibiotic therapy within 15 days prior to screening.
- •Prior history of significant renal or bone disease.
- •Subjects should avoid giving blood for the duration of this study.
- •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
研究者
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