EUCTR2007-002647-25-DE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 - THRIVE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •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. S’s HIV-1 plasma viral load at screening is = 5,000 HIV-1 RNA copies/mL
- •7. In the judgment of the inv., 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;
- •8. Demonstrated sensitivity to ABC and 3TC, AZT and 3TC, and/or TDF and FTC based on results from the screening virco®TYPE HIV-1 using the lower clinical cut-off or the biological cut-off on the screening virco®TYPE HIV-1 result) and available historical data;
- •9. S is HLA-B*5701 negative;HLA-B*5701 retesting is not required for S's with prior documented HLA-B*5701 negative results;
- •10. S agrees not to start ART before the baseline visit;
- •11. 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 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 subject’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
- •- 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 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, or other interventional procedure. Concurrent participation in non-interventional observational trials is allowed as long as there is no impact on objectives of this trial.
研究者
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