Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

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Вход / Регистрация

Линкът е запазен в клипборда

СъстояниеЗавършен

Спонсори

Ramathibodi Hospital

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT02442700

BioSeek: nct02442700

Ключови думи

Резюме

Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in HIV-infected patients who are on antiretroviral therapy especially protease inhibitors including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals. The study was conducted as a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given the other treatment for an additional 12 weeks. Patients were observed for lipid profiles including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL); and the side effects including clinical and laboratory (serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase (CPK)). The follow-up visits were every 4 weeks until the end of the study.

Дати

Последна проверка:	07/31/2016
Първо изпратено:	02/24/2015
Очаквано записване подадено:	05/09/2015
Първо публикувано:	05/12/2015
Изпратена последна актуализация:	08/15/2016
Последна актуализация публикувана:	10/09/2016
Дата на първите подадени резултати:	04/07/2016
Дата на първите подадени резултати от QC:	08/15/2016
Дата на първите публикувани резултати:	10/09/2016
Действителна начална дата на проучването:	04/30/2014
Приблизителна дата на първично завършване:	12/31/2014
Очаквана дата на завършване на проучването:	12/31/2014

Състояние или заболяване

HIV

Dyslipidemia

Интервенция / лечение

Drug: pitavastatin

Drug: placebo

Фаза

Фаза 4

Групи за ръце

Arm	Интервенция / лечение
Experimental: Treatment sequence A, B Treatment visits were seperated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
Experimental: Treatment sequence B, A Treatment visits were seperated by a 2-week washout period. Treatment B = adminstration placebo for 12 weeks; Treatment A = adminstration pitavastatin for 12 weeks

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Приема здрави доброволци	Да
Критерии	Inclusion Criteria: - aged ≥18 years - able to provide informed consent - had confirmed HIV infection - on ART including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that were not changed within 12 weeks before the randomization - patients who had cholesterol level between 200 and 500 and LDL between 130 and 400 mg/dL without any lipid-lowering agent or discontinued the lipid-lowering agent at least 1 month prior to randomization Exclusion Criteria: - had the history of pitavastatin and/or the constituent of the drugs allergy - known history of myocardial infarction and/or ischemic stroke within 1 month prior to the randomization that would be endangered if we stopped the previous lipid-lowering agent before the enrollment - abnormal AST and ALT with level ≥5 times in asymptomatic patients or ≥3 times of upper normal limit (UNL) in symptomatic patients - pregnancy or breastfeeding - on cyclosporine which had major drug interactions with pitavastatin - patients who denied to join the study

Резултат

Първични изходни мерки

1. Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir [12 weeks]

Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.

Вторични изходни мерки

1. Safety of Pitavastatin in HIV-infected Patients [12 weeks]

Safety clinical was defined by FDA; grade 1 mild symptoms; grade 2 moderate symptoms with limiting age-appropriate IADL; grade 3 severe symptoms with limiting self-care ADL, But not immediately life-threatening; grade 4 life-threatening consequences; and grade 5 death related to adverse event. Safety laboratory evaluation was determined safe if AST, ALT, and/or CPK level was not increased significantly comparing pitavastatin to placebo.

Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

Ключови думи

triglyceride

reductase

protease

хиперлипидемии

дислипидемии

alanine aminotransferase

аланин

креатинин