EUCTR2004-004055-19-GB进行中（未招募）1 期
A Phase IIb randomized, partially blinded, dose-finding trial of TMC278 in antiretroviral naive HIV-1 infected subjects. - N/A
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
入选标准
- •Subjects who meet all of the following criteria are eligible for this trial:
- •1. Male or female subjects, aged 18 years or above.
- •2. Subject having documented HIV-1 infection.
- •3. Subject is willing to sign the informed consent form voluntarily.
- •4. Cortisol of at least 550 nmol/L (19.9 µg/dL) at least at one of the 3 timepoints (i.e., morning cortisol, 30 or 60 minutes after 250 µg ACTH stimulation) on the screening assessment.
- •5. Subject can comply with the protocol requirements.
- •6. HIV-1 plasma viral load at screening visit above 5000 HIV-1 RNA copies/mL (assayed by RNA polymerase chain reaction standard specimen procedure).
- •7. In the judgement of the investigator, it is appropriate to initiate ARV therapy based on the
- •subject's clinical condition and taking into account guidelines for the treatment of HIV-1 infection.
- •8. Subject has never been treated with an ARV drug or therapeutic HIV vaccine, or has received = 2 weeks treatment prior to screening with an NRTI and/or PI.
- •9. Screening virco®TYPE HIV-1 demonstrates sensitivity to investigator selected nucleosides.
- •10. Subject agrees not to start ARV before the baseline visit.
- •11. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
- •Criteria for Entering the Optional Open-Label Extention Part I, II:
- •1. The subject has completed the entire 96-week treatment period and has voluntarily agreed to participate (i.e., has signed the updated ICF).
- •2. The subject has completed the entire 144-week treatment period and has voluntarily agreed to participate (i.e., has signed the updated ICF).
- •3. The subject is willing to comply with the protocol requirements and cooperate with the investigator.
- •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. Use of disallowed conc. therapy
- •2. History of or currently active alcohol or drug use which will likely compromise subjects’ safety and/or compliance with trial procedures.
- •3. Life expectancy less than 6 months.
- •4. Subject has any currently active AIDS defining illness with the following exception:
- •- Stable, cutaneous Kaposi Sarcoma that is unlikely to require any form of systemic therapy during the trial period;
- •- Wasting syndrome due to HIV infection if 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.
- •5. Any active clinically significant disease or findings during screening of medical history or physical examination that, in the investigator’s opinion, would compromise the outcome of the trial.
- •6. Subject has known or suspected acute (primary) HIV-1 infection.
- •7. Any use of NNRTIs.
- •8. Acute hepatitis A, B, or C infection.
- •9. Having documented genotypic evidence of NNRTI resistance at screening or from historical data available in the source documents.
- •10. Any current or history of adrenal disorder.
- •11. Receipt of any investigational drug within 90 days prior to the trial drug administration.
- •12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the
- •components of the investigational medication.
- •13. Pregnant or breastfeeding female.
- •14. Female of childbearing potential without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and until 14 days after the end of the trial (or after last intake of ARVs).
- •Note: Hormonal based contraception may not be reliable when taking TMC278, therefore to be eligible for this trial, women of childbearing potential should either:
- •1) use a double barrier method to prevent pregnancy;
- •2) use hormonal based contraceptive in combination with a barrier contraceptive;
- •3) use an intrauterine device in combination with a barrier contraceptive;
- •4) be non-heterosexually active, practice sexual abstinence or have a vasectomized partner.
- •Note: Women who are postmenopausal for at least 2 years, women with total
- •hysterectomy and women who have had a tubal ligation are considered of nonchildbearing potential.
- •15. Heterosexually active males without the use of effective birth control methods or not willing to continue practicing these birth control metho
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