NCT00106379已完成4 期
A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 8
- 主要终点
- HIV-1 infection
研究概览
简要总结
The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.
详细描述
The primary objective of this study is as follows:
- To evaluate the safety and tolerability of tenofovir following administration of tenofovir disoproxil fumarate 300 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.
The secondary objectives of this study are as follows:
- To evaluate the safety and tolerability of emtricitabine following administration of emtricitabine 200 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.
- To evaluate the efficacy of tenofovir disoproxil fumarate in combination with emtricitabine in renally-impaired HIV-infected patients.
- To evaluate the pharmacokinetics of tenofovir and emtricitabine in renally-impaired HIV-infected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for participation in the study.
- •HIV-1 infection
- •Either antiretroviral therapy-naive requiring antiretroviral treatment with HIV-1 RNA greater than 400 copies/mL or antiretroviral therapy-experienced on a stable antiretroviral regimen for at least 3 mos. with HIV-1 RNA less than or equal to 50 copies/mL at screening.
- •No active opportunistic infection within 45 days prior to baseline.
- •Able to understand and sign the informed consent form and comply with the study.
- •Stable renal impairment within the four defined groups for at least 3 mos., based on creatinine clearance (Cockcroft-Gault method).
排除标准
- •Patients who meet any of the following are not to be enrolled in this study.
- •Women who are pregnant or breastfeeding
- •Fanconi syndrome or multiple myeloma, tertiary hyperparathyroidism, malignancy (with the exception of basocellular carcinoma) or myeloproliferative disorder.
- •Women of childbearing potential who are unwilling to use an effective contraceptive method during the study
- •Contraindications to tenofovir DF, emtricitabine or efavirenz
- •Undergoing treatment for tuberculosis
- •Using atazanavir
- •Prior history of mutation M184V, K65R or T69 insertion
- •Z-score on pre-baseline DEXA scan less than -2.5
- •The following laboratory values within 30 days prior to study entry: *absolute neutrophil count (ANC) less than 750/mm3, *hemoglobin less than 9.0 g/dL, *platelet count less than 50,000/mm3, *AST (SGOT) or ALT (SGPT) less than 5 x ULN and *CD4 cell count less than 100/mm
- •Use of nephrotoxic agents or competitors with renal excretions, including aminoglycoside antibiotics, intravenous amphotericin B, cidofovir, cisplatin, foscarnet, intravenous pentamidine, probenecid or other agents with significant nephrotoxic potential
- •Clinically significant cardiac, pulmonary or gastrointestinal disorder
- •Alcohol or drug abuse that could hinder compliance with the study
结局指标
主要结局
HIV-1 infection
次要结局
- HIV-1 infection in renally impaired HIV infected patients
研究者
研究点 (8)
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