EUCTR2007-003133-16-DE进行中（未招募）1 期
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult subjects (=18 years or minimum age that defines an adult as determined by local regulatory authorities or legal requirements) of either sex or any race with CCR5-tropic HIV infection.
- •2. Cumulative lifetime anti-retroviral therapy exposure of =4 weeks (with the exception of prophylaxis to prevent mother-to-child transmission) and none in the 8 weeks preceding randomization.
- •3. A CD4 cell count of =100 cell/mm3 at Screening (or as specified by local treatment guidelines).
- •4. HIV RNA must be =2000 copies/mL at Screening.
- •5. Subjects should meet IAS, DHSS, or local recommendations for initiation of ART.
- •6. Platelet count must be =50,000/µL, hemoglobin =8 g/dL, absolute neutrophil count =1000/µL, serum creatine <2.0 mg/dL (154 µmol/L), and SGOT/SGPT =3 x ULN at Screening. Other clinical laboratory tests must be within normal limits or clinically acceptable to the investigator.
- •7. Female subjects of childbearing potential must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study, or must have been surgically sterilized.
- •8. Female subjects of childbearing potential must have a negative serum beta-hCG (human chorionic gonadotropin) pregnancy test at Screening and a negative urine beta-hCG pregnancy test on Day 2 prior to dosing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant.
- •2. Subjects with intercurrent illness, vaccinations, or who have used immunomodulators (within the 4-week period prior to randomization) that could influence plasma HIV RNA levels.
- •3. CXCR4 or dual-mixed (CXCR4 and CCR5) tropism.
- •4. Subjects with primary resistance mutations to any of proposed components of the study arms.
- •5. Subjects with active opportunistic infection or malignancy.
- •6. Subjects with seizure disorder requiring ongoing anti-seizure therapy or with a history of a seizure disorder who are, in the judgment of the investigator, at risk for seizures.
研究者
相似试验
进行中（未招募）
不适用
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve SubjectsHuman Immunodeficiency Virus (HIV) InfectionMedDRA version: 9.1Level: LLTClassification code 10200172Term: <Manually entered code. Term in E.1.1>EUCTR2007-003133-16-PTSchering-Plough Research Institute80
进行中（未招募）
不适用
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects - P04875HIV INFECTION IN NAIVE PATIENTSMedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infectionEUCTR2007-003133-16-ITSCHERING-PLOUGH80
进行中（未招募）
不适用
Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Substudy of P03802 - NAEUCTR2005-001843-49-DESchering Plough Research Institute80
已完成
2 期
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875)HIV InfectionsNCT00551018Merck Sharp & Dohme LLC218
进行中（未招募）
不适用
Eficacia y seguridad del VICRIVIROC en sujetos infectados por el VIH que nunca han recibido tratamiento.EUCTR2007-003133-16-ESSchering-Plough Research Institute80