EUCTR2007-002646-38-IT进行中（未招募）不适用
A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects - ECHO
TIBOTEC PHARMACEUTICALS LTD.0 个研究点目标入组 680 人开始时间: 2008年7月21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
- 680
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
- •Male or female subjects, aged 18 years or older; 0083677, Final, 15-Oct-2007 17:04 TMC278-TiDP6-C209 Revised Clinical Trial Protocol 22 2. Subject with documented HIV-1 infection; 3. Subject has signed the ICF voluntarily; 4. Subject can comply with the protocol requirements; 5. Subject has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening; 6. HIV-1 plasma viral load at screening is ≥ 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure); 7. In the judgment of the investigator, it is appropriate to initiate ARV therapy based on the subject?s medical condition and taking into account guidelines for the treatment of HIV-1 infection; 8. Demonstrated sensitivity to TDF and FTC based on results at screening or based on available historical data, when using the lower clinical cut-off (indicated as ?Maximal Response?) or the biological cut-off (indicated as ?susceptible?) on the screening vircoTYPE HIV-1 result; 9. Subject agrees not to start ART before the baseline visit; 10. Subject?s general medical condition, in the investigator?s opinion, does not interfere with the assessments and the completion of the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission; 2. Having documented genotypic evidence of NNRTI resistance at screening or from historical data available in the source documents, i.e., at least one of the NNRTI RAMs from the following list: A098G L100I K101E K101P K101Q K103H K103N K103S K103T V106A V106M V108I E138G E138K E138Q V179D V179E Y181C Y181I Y181V Y188C Y188H Y188L G190A G190C G190E G190Q G190S G190T P225H F227C M230I M230L P236L K238N K238T 3. Previously documented HIV-2 infection; 4. Use of disallowed concomitant therapy from 4 weeks prior to baseline visit (see Section 5.3.13); 5. Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject?s safety or adherence to the protocol; 6. Life expectancy less than 6 months; 7. Subject has any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions: - Stable, cutaneous Kaposi Sarcoma (i.e., no pulmonary or gastrointestinal involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial period; - Wasting syndrome due to HIV infection if, in the investigator?s opinion, it is not actively progressive and its treatment does not require hospitalization or compromise the subject?s safety or compliance to adhere to the trial protocol procedures. If the subject is on maintenance therapy (which may include human Growth Hormone, appetite stimulants, and anabolic steroids) for previously diagnosed wasting syndrome, he/she may be eligible for the trial only if such treatment is not included in the list of disallowed medications; - Pneumocystis Carinii Pneumonia (PCP) infection that is considered cured and the acute phase ended at least 30 days ago, and for which currently no therapeutic treatment is required (PCP prophylaxis is allowed, as long as it is not included in the list of disallowed medications); - Past occurrence of cryptococcosis that is considered to be fully cured and the acute phase ended at least 30 days ago, and/or for which no therapeutic treatment is required. Note: An AIDS defining illness not clinically stabilized for at least 30 days will be considered as currently active. 8. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction, active and significant psychiatric disorder, clinical suspicion of adrenal insufficiency), or findings during screening or medical history or physical examination that in the investigator?s opinion, would compromise the outcome of the trial; 9. Subject has active tuberculosis and/or is being treated for tuberculosis at screening; Note: Subjects who develop tuberculosis during the trial will be withdrawn from the trial to allow appropriate tuberculosis therapy to be installed. 10. Subject has known or suspected acute (primary) HIV-1 infection; 11. Subject has one or more of the follwing risk factors for QTc prolongation: - A confirmed prolongation of QT/QTc interval, e.g., repeated demonstration of QTcF (Fridericia correction) interval > 450 ms in the screening ECG (i.e., retesting to reassess eligibility will be allowed once using an unscheduled visit during the screening period); - Pathological Q-waves (defined as Q-wave
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