EUCTR2008-006873-33-PT进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC AND 48-WEEK SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2-18 YEARS OF AGE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 103
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
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment
- •into the study:
- •1. Provide a signed and dated written Informed Consent Document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study;
- •2. Subjects 2-18 years of age available for follow-up period of at least 48 weeks;
- •3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
- •4. HIV-1 RNA =1,000 copies/mL measured by Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test;
- •5. Stable pre-study ARV regimen for at least 4 weeks prior to Screening Visit or no pre-study ARV regimen for at least 4 weeks prior to Screening Visit:
- •? If already receiving ARV therapy prior to Screening Visit, component ARV drugs must not be changed in the prior 4-week period. However, change in dose (for weight gain) or change in formulation of ARV drug is allowed. Subjects will be required to remain on their existing regimen during the Screening period.
- •? Subjects with unchanged ARV regimen for at least 4 weeks prior to Screening and experiencing virologic failure (defined as plasma HIV-1 RNA =1,000 copies/mL).
- •6. Experience/intolerance ?6 months (sequential or cumulative) with at least 2 ARV drug classes;
- •7. Willing to remain on treatment without any changes or additions to OBT regimen, except for toxicity management or upon meeting criteria for virologic failure;
- •8. ****For Women of Child Bearing Potential (WOCBP), a negative urine pregnancy test at the Baseline Visit. Serum pregnancy tests may be performed in lieu of urine pregnancy tests where mandated.
- •NOTE: WOCBP include any female who has experienced menarche. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products (intrauterine devices; barrier methods: eg, condom or diaphragm with spermicide) to prevent pregnancy, who are practicing abstinence, or who have a partner that is sterile (eg, vasectomy), should be considered to be of child bearing potential.****
- •9. ****Effective barrier contraception for sexually active WOCBP and males. In addition, sexually active WOCBP must use another acceptable method of contraception for the duration of the study and up to 28 days following the last maraviroc dose. Acceptable contraception includes, but is not limited to, oral, implanted or injectable hormone therapy and intrauterine devices. Complete abstinence may be considered acceptable in some cases. The investigator may discuss the forms of contraception (including abstinence) with subject and/or guardian.****
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 103
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1. Subjects requiring treatment with more than 5 ARV agents in OBT regimen (low dose ritonavir is not considered a separate ARV agent);
- •2. Prior treatment with maraviroc, another CCR5 antagonist or another experimental HIV entry inhibitor for more than 14 days;
- •3. History of poor adherence with medication, active alcohol or substance abuse sufficient to prevent adherence to study medication and/or Follow-Up;
- •4. Current systemic chemotherapy or history of malignancy;
- •5. Lactating women or planned pregnancy during the trial period;
- •6. Suspected or documented active, untreated HIV-1 related opportunistic infection or other condition requiring acute therapy (eg, Hepatitis C virus infection) at Baseline Visit;
- •NOTE: Subjects on stable (>1 month) secondary OI prophylaxis regimen or chronic treatment (eg, Hepatitis C) are eligible for the study. Subjects on primary OI prophylaxis regimen of any duration are also eligible for the study;
- •7. Treatment for an active opportunistic infection, or unexplained T>38.5°C for 7 consecutive days, within 30 days prior to Baseline Visit;
- •8. Known hypersensitivity or history of allergy to any component of maraviroc, including soy lecithin or peanuts;
- •9. Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 60 days prior to Baseline, or the expected need for such therapy during the study period;
- •10. Documented or suspected acute hepatitis or pancreatitis within 30 days prior to Baseline Visit;
- •11. Known =Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit:
- •? Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase; NOTE: Subjects with a change of two or more grades in AST or ALT between Screening and Baseline Visits must be reviewed by Pfizer.
- •? Total bilirubin = Grade 3, unless ALL of the following are true:
- •? Current regimen includes atazanavir;
- •? ALT/AST = 2.5 X ULN;
- •? No symptoms other than jaundice or icterus.
- •NOTE: Subjects with a change of two or more grades in direct bilirubin between Screening and Baseline Visits must be reviewed by Pfizer.
- •? Other laboratory values = Grade 3, must be reviewed by Pfizer.
- •12. History of lactic acidosis within the 3 months prior to Screening. Lactic acidosis defined as:
- •? Either confirmed lactate =2 X ULN in subjects with ALT and AST values >2.5 X ULN without easily discernable etiology (eg, acute Hepatitis A, B, C or chronic Hepatitis B or C); OR
- •? New and persistent, otherwise unexplained nausea, vomiting, abdominal pain,
- •abdominal distention, unexplained fatigue, and dyspnea.
- •13. Cirrhosis of the liver;
- •14. ****Abnormal renal function (creatinine clearance less than 90 mL/min as calculated based on local standards);
- •15. Clinically significant malabsorption syndrome (>6 loose stools per day, for at least 7 consecutive days) within 30 days prior to Baseline;
- •16. X4- or dual/mixed-tropic virus detecte
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