NCT00648817已完成4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- To assess the impact on insulin sensitivity (determined by peripheral glucose uptake suing a euglycaemic clamp) of the administration of tenofovir DF compared with placebo for two weeks in HIV-1 seronegative healthy male volunteers.
研究概览
简要总结
Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg compared with placebo in non-HIV-1 infected healthy adult males. Additionally, endothelial function, adipocytokines and lipids will be monitored.
详细描述
Double-blind, randomized, placebo-controlled study using a two-sequence two-period crossover structure. Sixteen HIV-1-negative males will be randomized 1:1 to one of two treatment arms.
Group 1:
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the first 14 days of the study.
- Tenofovir DF placebo tablet QD for the last 14 days of the study.
Group 2:
- Tenofovir DF placebo tablet QD for the first 14 days of the study.
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the last 14 days of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
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 according to the Cockcroft Gault formula: Male: [(140 - age in years) x (actual body wt in kg)]/[72 x (serum creatinine in mg/dL)]= CrCl (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 <= 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
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.
研究组 & 干预措施
Group 1
Placebo Comparator
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the first 14 days of the study.
- Tenofovir DF placebo tablet QD for the last 14 days of the study.
干预措施: Tenofovir Disoproxil Fumarate (Drug)
Group 1
Placebo Comparator
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the first 14 days of the study.
- Tenofovir DF placebo tablet QD for the last 14 days of the study.
干预措施: Tenofovir DF placebo (Drug)
Group 2
Active Comparator
- Tenofovir DF placebo tablet QD for the first 14 days of the study.
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the last 14 days of the study.
干预措施: Tenofovir Disoproxil Fumarate (Drug)
Group 2
Active Comparator
- Tenofovir DF placebo tablet QD for the first 14 days of the study.
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the last 14 days of the study.
干预措施: Tenofovir DF placebo (Drug)
结局指标
主要结局
To assess the impact on insulin sensitivity (determined by peripheral glucose uptake suing a euglycaemic clamp) of the administration of tenofovir DF compared with placebo for two weeks in HIV-1 seronegative healthy male volunteers.
次要结局
- To assess endothelial function by monitoring changes in Selectin P/E and PAI-1 assays.
- To monitor adipocytokines by assessing adiponectin and leptin levels.
- To monitor lipids by assessing large and small lipoprotein sub-fractions of HDL and LDL cholesterol, triglycerides, and non esterified fatty acid concentrations.
研究者
研究点 (1)
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