A Multicenter, Open-label Study Evaluating the Safety and Efficacy of a New Protease Inhibitor (Darunavir) With Fuzeon® (Enfuvirtide) Plus Background Antiretroviral Regimen in HIV-1 Infected, Triple-class Treatment-experienced Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
研究概览
简要总结
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.
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
- •adult patients, >=18 years of age;
- •seropositive for HIV-1;
- •enrolled in an early access program for a new investigational PI;
- •naive to Fuzeon, and the investigational PI;
- •treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
排除标准
- •females who are pregnant or breast-feeding;
- •evidence of active, untreated opportunistic infection;
- •malignancy requiring chemotherapy or radiotherapy.
研究组 & 干预措施
Enfuvirtide+PI+ARV's
Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
干预措施: Background ARVs (Drug)
Enfuvirtide+PI+ARV's
Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
干预措施: PI (Drug)
Enfuvirtide+PI+ARV's
Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
干预措施: enfuvirtide [Fuzeon] (Drug)
结局指标
主要结局
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
时间窗: Week 24
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results \<50 copies/mL is reported.
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
时间窗: Week 24
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results \<50 copies/mL is reported.
次要结局
- Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL(Week 4 and 12)
- Change From Baseline in CD4+ Lymphocyte Count(Baseline (Day 1), Weeks 4, 12, and 24)
- Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL(Weeks 4, 12, and 24)
- Percentage of Participants Meeting Virologic Failure Criteria(Weeks 12 and 24)
- Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL(Week 4 and 12)
- Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL(Weeks 4, 12, and 24)
- Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event(Week 1 to Week 24)
- Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.(Week 24)
- Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load(Baseline (Day 1), Weeks 4, 12, and 24)
- Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)(Up to Week 28)
- Percentage of Participants Adhering to ENF(Weeks 4, 12, and 24)
- Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event(Week 1 to Week 24)
- Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events(Up to Week 24)
- Number of Participants Meeting Virologic Failure Criteria(Weeks 12 and 24)
- Number of Participants Adhering to Enfuvirtide (ENF)(Weeks 4, 12, and 24)