EUCTR2007-002646-38-DK进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Male or female subjects, aged 18 years or older;
- •2. S (Subject) with documented HIV-1 infection;
- •3. S has signed the ICF voluntarily;
- •4. S can comply with the protocol requirements;
- •5. S 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);
- •Note: Retesting of HIV-1 plasma viral load to reassess eligibility will be allowed only once using an unscheduled visit during the screening period.
- •7. In the judgment of the investigator, it is appropriate to initiate ARV therapy based on the S’s medical condition and taking into account guidelines for the treatment of HIV-1 infection;
- •Note: Most current treatment guidelines recommend considering initiation of ART when CD4+ cell counts are below 350 cells/µL. However, clinical situations may warrant initiating ART with CD4+ cell counts above 350 cells/µL. Examples of such situations would include rapidly declining CD4+ cell counts over time, high plasma viral load, history of AIDS-defining illnesses, or severe symptoms of HIV 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 virco®TYPE HIV-1 result;
- •9. S agrees not to start ART before the baseline visit;
- •10. S’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
- •1. Any previous treatment with a therapeutic HIV vaccine or use of ARVs, incl. use of NVP for the prevention of vertical HIV transmission
- •2. Having documented genotypic evidence of NNRTI resistance at screening or from historical data avail. in the source docs, i.e. at least 1 of the NNRTI RAMs from follow. list:
- •3. Previously documented HIV-2 infection
- •4. Use of disallowed concomitant therapy from 4 weeks prior to baseline visit
- •5. Any condition which, in the opinion of the inv., could compromise the S’s (safety or adherence to CTP
- •6. Life expectancy < 6 months
- •7. S has any currently active AIDS defining illness with follow. 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 trial period
- •- Wasting syndrome due to HIV infection if, in the inv.’s opinion, it is not actively progressive and its treatment does not require hospitalization or compromise the S's safety or compliance to adhere to CTP procedures. If the S is on maintenance therapy for previously diagnosed wasting syndrome, (s)he may be eligible for the trial only if such treatment is not incl. in list of disallowed medications
- •- Pneumocystis Carinii Pneumonia 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 incl. in 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
- •8. Any active clinically significant disease (eg. pancreatitis, cardiac dysfunction, active and significant psychiatric disorder, clinical suspicion of adrenal insufficiency, hepatic
- •impairment), or findings during screening or medical history or physical examination that in the inv.’s opinion, would compromise the outcome of the trial
- •9. S has active tuberculosis and/or is being treated for tuberculosis at screening
- •10. S has known or suspected acute (primary) HIV-1 infection
- •11. S has one or more of follow. risk factors for QTc prolongation:
- •- A confirmed prolongation of QT/QTc interval, eg. repeated demonstration of QTcF
- •(Fridericia correction) interval > 450 ms in the screening ECG
- •- Pathological Q-waves
- •- Evidence of ventricular pre-excitation
- •- Electrocardiographic evidence of complete or incomplete left bundle branch block or
- •right bundle branch block
- •- Evidence of 2nd or 3rd degree heart block
- •- Intraventricular conduction delay with QRS duration > 120 ms
- •- Bradycardia as defined by sinus rate < 50 bpm
- •- Personal or family history of long QT syndrome
- •- Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, with the exception of sinus arrhythmia
- •- Syncopal episodes
- •- Risk factors for Torsades de Pointes (eg. heart failure, hypokalemia, hypomagnesemia)
- •12. Receipt of any investigational drug or investigational vaccine within 90 days prior to first trial drug administration
- •13. S enrolled in other clinical trials that incl. any blood sampling with a volume
- •higher than 50 mL taken over the course of 6 months, specimen
- •collection, o
研究者
相似试验
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 - ECHOHIV infectionMedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infectionEUCTR2007-002646-38-SETibotec Pharmaceuticals680
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 background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects - THRIVEEUCTR2007-002647-25-DETibotec Pharmaceuticals680
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 - ECHOEUCTR2007-002646-38-ITTIBOTEC PHARMACEUTICALS LTD.680
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 background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects - THRIVEHIV-1 INFECTIONMedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infectionEUCTR2007-002647-25-ITTIBOTEC PHARMACEUTICALS LTD.680
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 - ECHOHIV infectionMedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infectionEUCTR2007-002646-38-ATTibotec Pharmaceuticals680