NL-OMON30522已完成不适用
Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options. - TMC125-C214
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject or Legal Authorized Representative has voluntarily given informed consent before initiation of trial procedures.
- •2. Subject has documented HIV-1 infection.
- •3. Male or female subject (lower age limit 16 or 18 years of age, depending on local regulation)
- •4. Subject has limited treatment options due to virological failure or intolerance to multiple ARV regimens.
- •5. Subject is at least 3-class experienced (3 classes of licensed oral ARVs: N[t]RTIs, PIs, NNRTIs).
- •Note: Subjects with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria.
- •6. Subject has previously received 1 different PI-based regimens.
- •7. Subject is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance.
- •8. Subject, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen (defined as a confirmed detectable plasma VL >or=50 copies/ml on the current treatment). A subject who does achieve adequate virologic suppression is only eligible if
- •*subject has treatment-limiting toxicity to an agent in his/her ARV regimen that requires substitution of this agent;
- •*subject is at risk of viral rebound and in the opinion of the investigator an intensification of the ARV regimen is appropriate;
- •*subject previously participated in another TMC125 clinical trial or program
排除标准
- •1. Primary HIV infection.
- •2. Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).This exclusion criterium was removed according to TMC125-C214-CTPA-GEN-II, dated 10 Oct 07.
- •3. 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.
- •4. Use of disallowed concomitant therapy, including disallowed ARVs (See Section 5.3.8.2 protocol).
- •5. Use of non-ARV investigational medications within the 30 days prior to baseline visit.
- •6. Use of investigational ARVs, unless stated as an exception in Section 5.3.8.2.2. of the protocol
- •7. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the screening phase of the trial.
- •8. Acute viral hepatitis, including but not restricted to A, B or C.
- •9. Pregnant or breast-feeding female.
- •10. Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
- •Note: Hormone based contraception may not be reliable when taking TMC125; therefore, to be eligible for this trial, women of childbearing potential who may have vaginal intercourse should either:
- •(1) Use a double barrier method to prevent pregnancy (i.e., use a condom without spermicide, with either a diaphragm or cervical cap) or
- •(2) Use hormone based contraceptives in combination with a barrier contraceptive (i.e., male condom without spermicide, diaphragm or cervical cap or female condom) or
- •(3) Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e., male condom without spermicide, diaphragm or cervical cap or female condom) or
- •Note: The use of an IUD has been associated with an increased rate of sexually transmitted diseases.
- •(4) Be non-heterosexually active, practice sexual abstinence or have a vasectomized partner (confirmed sterile).
- •Note: Women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential.
- •11. Subjects with the following laboratory abnormalities as defined by a standardized grading scheme based on the Division of AIDS (DAIDS) grading table (updated version from December 2004, see Section 7.2 van het protocol):
- •- Hemoglobin < 7.4 g/dL (4.5 mmol/L)
- •- Absolute neutrophil count < 500/mm³ (0.500 x 109/L)
- •- Platelets <25,000/mm3 (25.000 x 109/L)
- •- Prothrombin time (PT) >1.50 x upper limit of laboratory normal range (ULN)
- •Note: Subjects on anticoagulant therapy with elevated PT >1.5 ULN require approval of the sponsor prior to enrollment.
- •- Alkaline phosphatase >5 x ULN
- •- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) >5 x ULN
- •- Bilirubin > 5 x ULN
- •Note: Subjects with elevated bilirubin >5xULN assessed as related to a component of ART therapy may be enrolled with prior approval of the sponsor.
- •- Lipase >3 x ULN
- •- Amylase >5 x ULN if lipase >2 x ULN
- •- Creatinine >1.8 x ULN
- •12. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme
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