Phase IIb pilot study for the evaluation of the safety and the feasibility of treatment simplification to tenofovir+emtricitabina+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological control and toxicity to the current combined antiretroviral regimen. - ND

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2009年7月29日最近更新: 2012年3月19日

试验速览

暂无简介。

•Patients treated with a combined antiretroviral therapy from at least 1 year
•Aged 18 years or older
•With one or more of the following conditions:
•Grade 3 or 4 Dyslipidemia
•Any Hyperglicemia
•Lipodystrophy (patient?s self report, confirmed by physician?s physical examination)
•Moderate/severe cardiovascular risk, defined as a calcium score higher than 40 or a Framingham score higher than 10 (estimated 10 years cardiovascular risk: 10%)
•Diarrhea (at least 3 emissions of loose stool every day for at least 3 days every week)
•With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart
•With CD4 cell count >200 cells/ μL for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.
•Who gave informed consent to the participation to the study
•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

•Pregnancy or breast feeding, desire of pregnancy in the short term
•Previous virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues except for patients with subsequent genotypic resistance tests showing no resistance mutations to any of the study drugs.
•Previous exposure to inhibitors of HIV-1 integrase
•Previous major toxicity to any of the study drugs
•Spontaneous treatment interruptions in disagreement with the treating physician in the last year or loss to follow-up for at least 6 months, at least once in the last two years
•Current alcohol or drug abuse or any other condition which, in the judgment of the treating physician, may impair the patient?s adherence to the new drug regimen and/or to the protocol?s procedures
•Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid and glucose levels)

发起方

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI