One arm, Open label, Interventional, non-comparative Study to assess Changes in Lipids and Lipoproteins in HIV infected Women with Hyperlipidemia after Switch from boosted Protease Inhibitors to Raltegravir - AGMT_HIV1

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 个研究点开始时间: 2013年10月22日最近更新: 2016年4月11日

试验速览

暂无简介。

•Signed informed consent
•Documented HIV-1 infection in female patients, age =18 years
•Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) including indinavir, fosamprenavir, saquinavir, lopinavir, atazanavir, tipranavir, or darunavir for at least the previous 6 months
•Plasma HIV viral load <200 copies/ml (as recommended by the Department of Health and Human Services DHHS Guidelines) on current boosted PI containing regimen for = 6 months prior to study entry
•Patients receiving prophylaxis or treatment for an opportunistic infection or malignancy may be included as long as following laboratory requirements were met approximately 1 month prior to screening:
•o hemoglobin > 8.0g/dl
•o neutrophil count > 750/µl
•o platelet count > 50000/µl
•o creatinine < 2.0mg/dl
•o both alanine and aspartate aminotransferases < 200mg/dl
•Fasting LDL cholesterol >130 mg/dl
•Fasting triglycerides <450 mg/dl
•For patients on lipid lowering agents, a stable regimen for the past 3 months will be required
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•Breast feeding or pregnancy or wish to become pregnant during the study period.
•Lack of expectation to maintain assigned medication during study period
•NRTI mutations
•Prior treatment with raltegravir
•Prior treatment with investigational drugs in the previous 3 months
•Need for medication with known interactions with raltegravir (rifampin for example)
•Active drug or alcohol abuse
•Unstable clinical condition
•Visceral Kaposi sarcoma
•Acute hepatitis in the previous 6 months
•Any condition or history or any illness which, in the opinion of the investigator, might confound the results of the study or pose additional risk when switching the therapy of the patient

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