Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 3 NCT02362503

Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

Фаза 3 – широко изпитване преди одобрение
Заболявания: HIV Infections

Спонсор: ViiV Healthcare

Налично на: БГ
Обобщение
The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
Кой може да участва
Inclusion Criteria: * Men and non-pregnant women with chronic HIV-1 infection * Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes * Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs) * Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety * Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort * Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort Exclusion Criteria: * Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible) * HIV-2 infection * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 7 x ULN * Alkaline Phosphatase \> 5 x ULN * Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)
Места на провеждане 24
Argentina (1)
GSK Investigational Site
Buenos Aires
Австралия (1)
GSK Investigational Site
Darlinghurst , New South Wales
Белгия (1)
GSK Investigational Site
Antwerp
Бразилия (1)
GSK Investigational Site
Belo Horizonte
Канада (1)
GSK Investigational Site
Vancouver , British Columbia
Chile (1)
GSK Investigational Site
Santiago
Colombia (1)
GSK Investigational Site
Bogotá
Франция (1)
GSK Investigational Site
Bordeaux
Германия (1)
GSK Investigational Site
Berlin
Гърция (1)
GSK Investigational Site
Athens
Ireland (1)
GSK Investigational Site
Dublin
Италия (1)
GSK Investigational Site
Milan
Mexico (1)
GSK Investigational Site
Chihuahua City
Нидерландия (1)
GSK Investigational Site
Utrecht
Peru (1)
GSK Investigational Site
Iquitos
Полша (1)
GSK Investigational Site
Szczecin
Puerto Rico (1)
GSK Investigational Site
San Juan
Румъния (1)
GSK Investigational Site
Bucharest
Russia (1)
GSK Investigational Site
Irkutsk
South Africa (1)
GSK Investigational Site
Auckland Park Johannesb
Испания (1)
GSK Investigational Site
Badalona
Taiwan (1)
GSK Investigational Site
Taipei
Великобритания (1)
GSK Investigational Site
Bournemouth
САЩ (1)
GSK Investigational Site
Los Angeles , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
23.02.2015
Крайна дата
30.09.2026
Регистрационен номер
NCT02362503
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.