A Multicenter, Open Label, Expanded Access Trial Of Maraviroc
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,047
- 试验地点
- 350
- 主要终点
- Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
研究概览
简要总结
To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
- •Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
- •Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.
排除标准
- •Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials
研究组 & 干预措施
1
干预措施: maraviroc (Drug)
结局指标
主要结局
Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
时间窗: Baseline up to Week 144
AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.
Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities
时间窗: Baseline up to Week 144
Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.
Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities
时间窗: Baseline up to Week 144
Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.
Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses
时间窗: Baseline up to Week 144
Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load
时间窗: Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
时间窗: Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
时间窗: Baseline up to Week 144
Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
时间窗: Baseline up to Week 144
Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race
时间窗: Baseline up to Week 144
Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age
时间窗: Baseline up to Week 144
Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.
Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status
时间窗: Baseline up to Week 144
Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.
次要结局
- Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)(Baseline up to Week 144)
- Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA(Baseline up to Week 144)
- Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL(Baseline up to Week 144)
- Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL(Baseline up to Week 144)
- Change From Baseline in CD4 Cell Count(Baseline up to Week 144)
- Change From Baseline in CD4 Cell Count Percent(Baseline up to Week 144)
- Change From Baseline in CD8 Cell Count(Baseline up to Week 144)
- Change From Baseline in CD8 Cell Count Percent(Baseline up to Week 144)
- Median Time to Virologic Failure(Day 1 up to Week 144)
- Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau(Baseline up to Week 144)
- Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)(Baseline up to Week 144)
- Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure(Baseline up to Week 144)
- Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure(Screening up to Week 144)