EUCTR2011-001635-23-PL进行中（未招募）不适用
PROTEAse inhibitor (DRV/rtv) in mono- or triple therapy in suppressed HIV-1 infected subjects
适应症
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
- 260
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. Have documented HIV-1 infection.
- •2. Be male or female aged >= 18 years old.
- •3. Criterion deleted per amendment.
- •4. Criterion modified per amendment.
- •4.1 Currently be receiving HAART for at least 48 weeks.
- •Note: HAART is defined as the combination of 2 N(t)RTIs with at least 1 additional ARV (3rd agent) from the non-nucleoside reverse transcriptase (NNRTI), or PI, or
- •integrase inhibitor class. Subjects should be on their first line HAART, however a previous change in nucleoside backbone, and/or switching within class or between classes for their 3rd agent, for toxicity reasons will be allowed.
- •5. Criterion modified per amendment.
- •5.1 Have at least 2 documented plasma HIV-1 RNA <50 copies/mL, and no HIV-1 RNA 50 or over 50 copies/mL in the 48 weeks prior to the screening visit.
- •6. Be taking the same ARV combination for at least 8 weeks before
- •7. Have the preference, together with the physician, to change the
- •current HAART regimen for reasons of simplification and/or toxicity
- •(examples of toxicities include but are not limited to: CNS, gastrointestinal disturbances, jaundice, anemia, nausea, neuropathy, paresthesia, hyperlipidemia, glucose intolerance or diabetes, nephrolithiasis, lipodystrophy, hepatotoxicity, rash and skin related events, any other AE or intolerability or laboratory abnormalities caused by current HAART).
- •8. Criterion modified per amendment.
- •8.1 Have no CD4+ cell counts below 100 cells/mm3, from the time of first known HIV infection to the start of HAART, and >200 cells/mm3 at screening or a maximum of 4 weeks prior to screening.
- •9. Be able to comply with the protocol requirements. In particular,
- •subjects should be willing to be followed up to Week 96 even if they
- •discontinue randomized treatment.
- •10. If heterosexually active, a female of childbearing potential and a
- •non-vasectomized male subject who has a female partner of childbearing potential must agree to use effective contraceptives from screening onwards until 30 days after completion of study treatment.
- •11. If a woman of childbearing potential, she must have a negative
- •serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at
- •screening; and a negative serum or urine pregnancy test before the first dose of study medication to ensure they are not pregnant at the time of starting treatment.
- •12. Criterion modified per amendment.
- •12.1 Have voluntarily signed and dated an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 255
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA >500 copies/mL after initial viral suppression while on previous or current antiretroviral therapy; Has a history of any primary PI mutations; Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency); Is diagnosed with acute viral hepatitis at screening or before Baseline 1.
- •Note: Subjects with acute viral hepatitis A or C are allowed to be rescreened when their condition is clinically stable and is not expected to require treatment during the study period.
- •Note: Subjects co-infected with chronic hepatitis C will be allowed to enter the study if their condition is clinically stable and is not expected to require treatment during the study period. See Sections 9.5.5.3 and 9.5.5.4 for further guidelines on enrolment of hepatitis C co-infected subjects.; Is coinfected with hepatitis B
研究者
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