NCT00040300已完成1 期
A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
Pharmasset0 个研究点目标入组 18 人开始时间: 2002年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.
详细描述
The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects may be eligible to participate if they:
- •Are males with HIV infection with a positive HIV antibody test
- •Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay)
- •Have CD4+ cell counts ≥ 50 cells/ml
- •Are 18-45 years of age, inclusive
- •Have a body mass index (BMI) ≥ 18 kg/m2
- •Are antiretroviral nucleoside reverse transcriptase inhibitor-naive
- •Have read and understand the informed consent,and is able and willing to comply with study procedures
排除标准
- •Subjects may not participate if they:
- •Have clinically significant ECG abnormalities
- •Have clinically significant abnormalities in any safety laboratory parameters
- •Have an ALT value ≥ 3xUNL
- •Have previously participated in this trial
- •Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug
- •Have a history of chronic alcohol or drug abuse within the last 6 months
- •Have a positive urine drug screening
- •Have a positive alcohol breath test
- •Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial
- •Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol
研究者
相似试验
已完成
1 期
Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers ChinaHealthyNCT03020134Ascletis Pharmaceuticals Co., Ltd.18
Unknown
3 期
Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV DrugsHIV InfectionsNCT00006397PPD Development, LP200
已完成
不适用
Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related MalignanciesHuman Papillomavirus (HPV)-Related MalignanciesRecurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related MalignanciesNCT02308241Memorial Sloan Kettering Cancer Center12
已完成
1 期
Use of Ribavirin and Low Dose Ara-C to Treat Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT01056523Jewish General Hospital29
已完成
4 期
Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)Hepatitis C, ChronicNCT00686777Merck Sharp & Dohme LLC75