A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase with Unboosted vs. Boosted Reyataz After an Induction Phase with Reyataz and Ritonavir in Treatment Naive HIV Patients Revised Protocol 03 Incorporating Protocol Amendments 02, 04 and 06 (Version 1.0, Date 19-June-2007). - The INDUMA Study

Bristol-Myers Squibb International Corporation0 个研究点目标入组 237 人开始时间: 2005年7月15日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•1) Written informed consent
•2) Treatment naïve HIV-1 infected subjects ( < 10 days of treatment with any ARV).
•3) Subjects who have an HIV-1 RNA level = 5000 c/mL at screening.
•4) Subjects who have a CD4 count = 50 cells/mm3.
•5) Men and women, ages 18 years of age or older (or minimum age as determined by
•local regulatory or as legal requirements dictate).
•6) Both females of child-bearing potential and males must utilize effective barrier
•contraception.
•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

•1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
•2) Women who are pregnant or breastfeeding
•3) Presence of a newly diagnosed HIV-related opportunistic infection or any medical
•condition requiring acute therapy at the time of enrollment
•4) Primary HIV infection
•5) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent
•adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
•6) Screening laboratory values measured as follows:
•a) Grade IV glucose,
•b) Grade IV electrolytes,
•c) Grade IV transaminases,
•d) Grade IV hematology.
•7) Hypersensitivity to any component of the formulation of study drug
•8) Prior history of taking any ARV for more than 10 days
•9) Concomitant administration of tenofovir (TDF).
•10) Any other clinical conditions or prior therapy that, in the opinion of the investigator and/or according to the Reyataz SmPC or any other local prescribing information for Reyataz (if more restrictive than the Reyataz SmPC), would make the subject unsuitable for study or unable to comply with the dosing requirements.
•11) Prisoners or subjects who are compulsorily detained

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