A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised Protocol 03, version v8.0, incorporating Protocol Amendments 03, 04 and 05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY

Bristol-Myers Squibb International Corporation0 个研究点目标入组 300 人开始时间: 2005年10月4日最近更新: 2012年5月1日

适应症

试验速览

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•- Provide written informed consent and capable of reading and comprehending the informed consent
•- HIV-1 infected subjects receiving current antiretroviral therapy defined as 2 NRTIs and a boosted PI for at least 12 weeks prior to screening. Prior treatment with PI or non-PI containing regimen(s) is allowed but subjects may not have experienced confirmed virological failure to more than one prior PI-containing regimen.
•- Subjects who have controlled virological response defined as HIV RNA level
•< 400 c/mL at screening and who have been stable for at least 6 months.
•- Subjects will be required to display signs of fat redistribution confirmed on physical
•examination by a clinician and defined by presence of lipohypertrophy with or without lipoatrophy. Participants considered to have lipohypertrophy must have a WHR > 0.90 and WC > 88.2 cm for men and WHR > 0.90 and WC > 75.3 cm for women.
•- Men and women, ages 18 years of age or older
•- 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) WOCBP using a prohibited contraceptive method.
•3) Women who are pregnant or breastfeeding.
•4) Women with a positive pregnancy test on enrollment or prior to study drug
•administration.
•5) Presence of a newly diagnosed HIV-related opportunistic infection or any medical
•condition requiring acute therapy at the time of enrollment.
•6) 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.
•7) Screening laboratory values measured as follows:
•a) Grade IV glucose,
•b) Grade IV electrolytes,
•c) Grade IV transaminases,
•d) Grade IV hematology.
•8) Hypersensitivity to any component of the formulation of study drug.
•9) Prior history of taking ATV.
•10) Prohibited concomitant therapies (see Protocol Section 6.4.1), including the use of NNRTIs.
•11) Any other clinical conditions or prior therapy that, in the opinion of the investigator,
•would make the subject unsuitable for study or unable to comply with the dosing
•requirements.
•12) Prisoners or subjects who are compulsorily detained

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