EUCTR2005-006179-11-IT进行中（未招募）不适用
A Phase II, open-label trial, to investigate pharmacokinetics, safety, tolerability and antiviral activity of TMC114/rtv b.i.d. in treatmentexperienced HIV-1 infected children and adolescents. - ND
TIBOTEC PHARMACEUTICALS LTD.0 个研究点目标入组 80 人开始时间: 2007年3月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •Subjects who meet all of the following criteria are eligible for this trial. 1. Boys and girls, aged between 6 and 17 years. 2. Subjects with documented HIV-1 infection. 3. Body weight Part I 8805; 20 to 50 kg. Body weight Part II 8805; 50 kg and from 8805; 20 to 50 kg after pediatric dose selection. 4. Being able to swallow the TMC114 tablet formulation s and the ritonavir capsule formulation, and to tolerate the ritonavir liquid formulation liquid formulation only applicable for subjects 40 kg . 5. Stable CD4 percentage no more than 5 decrease in CD4 percentage between the screening visit and the last available CD4 measurement with a minimum of 4 weeks and a maximum of 24 weeks between screening visit and last measurement . 6. Subjects currently on a stable ART who need to change their ARV regimen because it is currently failing at least 12 weeks on therapy , with a viral load of 1000 copies/mL. 7. Parents or legal representative and trial subjects where appropriate, depending on age and local regulation willing and able to give consent. Children will be informed about the trial, and asked to give positive assent as per description in Chapter II, Section 6.4. 8. Subjects can comply with the protocol requirements. 9. General medical condition, in the investigator s opinion, does not interfere with the assessments and the completion of the trial. 10. Female subjects who are sexually active and able to become pregnant must use a safe and effective birth control method, such as sexual abstinence or medically accepted barrier methods of contraception e.g., diaphragm, and condom during the study. Hormonal birth control alone would not be considered adequate, as the interaction between study drug and hormonal birth control is not available
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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 meeting one or more of the following criteria cannot be selected. 1. Part I Use of the NNRTI efavirenz as part of the current regimen is not allowed. Part II Use of efavirenz as part of the current regimen is allowed see Table 2 . 2. Presence of any currently active AIDS defining illness Category C conditions according to the CDC Classification System for HIV Infection 1993 or according to the 1994 revised CDC Classification System for HIV infection in children less than 13 years of age see Addendum 6; Section 7.6 Note An AIDS defining illness not clinically stabilized for at least 30 days will be considered as currently active. Note Primary and secondary prophylaxis for an AIDS defining illness is allowed in cases where the medication administered is not part of the disallowed medications see Section 5.5.12 . 3. Active substance use as determined by the investigator during anamnesis that includes but is not limited to daily or frequent alcohol intake, use of solvents, barbiturate, amphetamine, and recreational or narcotic drugs. Note Prescribed use of methadone is allowed see Table 2 . 4. Use of disallowed concomitant therapy see Section 5.5.12 . 5. Use of any antiretroviral and non-antiretroviral investigational agents within 30 days prior to screening, except for tenofovir, tipranavir, atazanavir and fosamprenavir. Note TMC114 should not be used within 14 days following the use of tipranavir. A minimal 14-day washout period is required in which tipranavir must be either interrupted or substituted to an investigator selected PI regimen until the baseline visit Day 1 . 6. Life expectancy of less than 6 months. 7. Co-enrollment in other clinical and/or cohort trials without written permission of the sponsor. 8. Pregnancy or breastfeeding. 9. Any active clinically significant disease e.g., TB, cardiac dysfunction, pancreatitis, acute viral infections or findings during screening of medical history or physical examination that, in the investigator s opinion, would compromise the subject s safety or outcome of the trial. 10. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication TMC114 or ritonavir. Note TMC114 is a sulfonamide. Subjects who previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and TMC114 has been identified in subjects participating in phase II trials. 11. Subjects with documented hepatic impairment. Note subjects co-infected with chronic hepatitis B or C determined by hepatitis B surface antigen, anti core-hepatitis B IgG antibody and hepatitis C antibody will be allowed to enter the trial if their condition is clinically stable, and they are not expected to require treatment during the study period and have ALT or AST levels 3 x ULN. Subjects diagnosed with acute viral hepatitis at screening will not be allowed in the trial e.g., hepatitis A IgM antibody . 12. Subjects with the following laboratory abnormalities as defined by the DAIDS grading scheme any grade 3 or 4 toxicity with the following exceptions unless clinical assessment foresees an immediate health risk to the subject - subjects with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or grade 4 - subjects with asymptomatic triglyceride or cholesterol elevations of grade
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