NCT00131677已完成2 期
Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Clinical Safety--Creatinine Elevations
研究概览
简要总结
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
详细描述
This study will assess the clinical and behavioral safety and tolerability of oral daily TDF use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in uninfected men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy biologic male (male at birth)
- •18-60 years of age
- •HIV-1 negative by licensed, commercially available, FDA-approved whole blood rapid enzyme immunoassay (EIA) at screening and enrollment
- •Reports any anal sex with a man in the last 12 months
- •Able to understand and pass comprehension assessment questionnaire
- •Able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •Able to understand English
- •Adequate renal function: calculated creatinine clearance of at least 70 mL/min
- •Hepatic transaminases (AST and ALT) less than or equal to 2x upper limit of normal (ULN)
- •Total bilirubin less than or equal to 1.5 mg/dL
- •Absolute neutrophil count at least 1,500/mm3;
- •Platelets at least 100,000/mm3;
- •Hemoglobin at least 9.5 g/dL
- •Serum amylase less than or equal to 1.5 x ULN
- •Biochemical profile: within normal limits for serum phosphorus, potassium, sodium, and calcium.
- •Hepatitis B surface antigen negative
- •Normal urine dipstick or urinalysis (UA)
排除标准
- •Active untreated syphilis
- •Current uncontrolled hypertension (blood pressure > 160/100 mmHg)
- •Mutually monogamous for > one year with a known HIV antibody negative partner
- •History of chronic renal disease, known osteoporosis, osteomalacia, or osteopenia
- •Current or expected participation in other longitudinal HIV behavioral or biomedical research study
- •Current HIV antiretroviral use
- •Receiving or planning to receive on-going therapy with any nephrotoxic agents or experimental/investigational agents
- •Previous or expected requirements for the administration of immunosuppressive/ immunomodulatory therapy (e.g. chronic systemic steroids, interferon, interleukins, chemotherapy, radiation).
- •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 participant compliance.
- •Imminently life-threatening medical conditions (malignancy, immunosuppressive disease [e.g. lymphoma]), or other serious disease or conditions (e.g. cardiovascular, renal, diabetes) within the last 5 years or that are unstable and/or require chronic medication that would impede compliance with study requirements and complicate the interpretation of adverse events
- •Expected to be non-compliant with study visits or planning to move within 24 months to an area where the study will not be conducted
- •Any other clinical or social condition, prior therapy, occupation, or other responsibility, that, in the opinion of the investigator, would interfere with, or serve as a contraindication to study participation or compliance with the dosing requirements.
研究组 & 干预措施
active immediate
Active Comparator
participants in this arm start study product immediately upon enrollment
干预措施: tenofovir disoproxil fumarate (Drug)
placebo immediate
Placebo Comparator
participants in this arm start study product immediately upon enrollment
干预措施: placebo (Drug)
active delayed
Active Comparator
persons in this arm start study product 9 months after enrollment
干预措施: tenofovir disoproxil fumarate (Drug)
placebo delayed
Placebo Comparator
participants in this arm start study product nine months after enrollment
干预措施: placebo (Drug)
结局指标
主要结局
Clinical Safety--Creatinine Elevations
时间窗: 24 months (immediate arm) and 15 months (delayed arm)
Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)
Clinical Safety--Hypophosphatemia
时间窗: 24 months (immediate arm), 15 months (delayed arm)
Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)
次要结局
- Number of Breakthrough HIV Infections(24 months (immediate arm) and 15 months (delayed arm))
- Behavioral Safety--Unprotected Anal Sex (UAS)(Nine months)
- Adherence to Study Drug(24 months (immediate arm) and 15 months (delayed arm))
研究者
研究点 (3)
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