NCT01579695终止不适用
A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 391
- 试验地点
- 29
- 主要终点
- Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
研究概览
简要总结
The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following inclusion criteria must be fulfilled:
- •Subject has given written informed consent;
- •Subject is an adult man or woman ≥ 18 years old;
- •Subject has HIV infection;
- •Subject has physical evidence of excess abdominal fat, as determined by the examining study physician.
- •Subject has completed standard of care assessments (mammography, cervical PAP smear, colonoscopy and blood work for HIV-1 RNA, CD4 cell count, renal, hepatic, and hematology, PSA test, fasting blood glucose, lipid panel ) prior to being enrolled onto the study.
排除标准
- •Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®.
- •Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma;
- •Active malignancy (newly diagnosed or recurrent)
- •Known hypersensitivity to tesamorelin and/or mannitol
- •Pregnancy or lactation
- •Use of EGRIFTA® within 6 months prior to baseline
- •Failure to complete any standard of care assessments listed in Section 5.2.1
研究组 & 干预措施
Exposed Group will receive Tesamorelin
干预措施: Tesamorelin for injection (Drug)
结局指标
主要结局
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
时间窗: 10 years
次要结局
- Time to development or worsening of Type 2 Diabetes Mellitus, diabetic retinopathy, hypersensitivity reactions, hepatic and renal function, adverse events and major adverse cardiovascular events(10 years)
研究者
研究点 (29)
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