NCT00993148已完成2 期
Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Percentage of Participants With Plasma HIV-1 RNA >50
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection, as documented by any licensed HIV test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry
- •Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtained within 90 days prior to study entry
- •Exclusive R5 tropism based on enhanced sensitivity Trofile assay done within 90 days prior to entry
- •CD4 cell count > 100 cells/mm3 within 90 days prior to study entry
- •HIV genotype (for RT and protease) performed at any time before study entry (Subjects with single or combination NNRTI or NRTI RAM(s) at screening are permitted)
- •ARV drug-naïve, defined as no previous ARV treatment at any time prior to study entry
- •Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
- •Negative result from a hepatitis C antibody test performed within 90 days prior to study entry
- •Laboratory values obtained within 30 days prior to study entry:
- •ANC >=750/mm3
- •Hemoglobin >=10 g/dL
- •Platelets >=50,000/mm3
- •AST (SGOT), ALT (SGPT), and alkaline phosphatase <=5 x ULN
- •Calculated creatinine clearance (CrCl) >=30 mL/min, as estimated by the Cockcroft-Gault equation*
- •Negative serum or urine pregnancy test within 48 hours prior to study entry for women with reproductive potential
- •If participating in sexual activity that could lead to pregnancy, the study subjects with reproductive potential must use one form of contraceptive while receiving protocol-specified medications and for 60 days after stopping the medications.
- •Men and women age >=18 years
- •Ability and willingness of subject or legal guardian/representative to provide informed consent
排除标准
- •Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry
- •Screening HIV genotype obtained any time prior to study entry with any DRV RAM (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V)
- •Treatment within 30 days prior to study entry with immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin, or any investigational therapy. NOTE: Subjects receiving stable physiologic glucocorticoid doses (defined as prednisone ≤10 mg/day [or equivalent] as a stable or tapering dose) are permitted. Subjects receiving corticosteroids for acute therapy for PCP or asthma exacerbation, or receiving a short course (defined as ≤2 weeks of pharmacologic glucocorticoid therapy) are permitted
- •Breast-feeding
- •Requirement for any medication that is prohibited with a study medication
- •Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion
- •Active drug or alcohol use or dependence that could interfere with adherence to study requirements
研究组 & 干预措施
Maraviroc plus darunavir/ritonavir
Experimental
Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
干预措施: maraviroc (Drug)
Maraviroc plus darunavir/ritonavir
Experimental
Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
干预措施: darunavir (Drug)
Maraviroc plus darunavir/ritonavir
Experimental
Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
干预措施: ritonavir (Drug)
结局指标
主要结局
Percentage of Participants With Plasma HIV-1 RNA >50
时间窗: 24 weeks
Percentage of participants with confirmed plasma HIV-1 RNA \> 50 copies/mL
次要结局
- Percentage of Participants With Virologic Failure or Off Study Treatment Regimen(24 weeks)
- Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL(48 weeks)
- Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher(96 weeks)
- Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES(At study entry and at the time of virologic failure)
- Drug Adherence, Number of Participants With Missed Doses(Week 24)
- Trough Concentrations (Ctrough) of Maraviroc(24 hours)
- Median CD4 Count Change From Baseline(96 weeks)
- Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL(96 weeks)
研究者
Babafemi Taiwo
Associate Professor
Northwestern University
研究点 (5)
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