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Active (not recruiting) Phase 3 NCT02362503

Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

Phase 3 – large-scale trial before approval
Conditions: HIV Infections

Sponsor: ViiV Healthcare

trial.available_in: БГ
Overview
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.
Who can participate
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)
Locations 24
Argentina (1)
GSK Investigational Site
Buenos Aires
Australia (1)
GSK Investigational Site
Darlinghurst , New South Wales
Belgium (1)
GSK Investigational Site
Antwerp
Brazil (1)
GSK Investigational Site
Belo Horizonte
Canada (1)
GSK Investigational Site
Vancouver , British Columbia
Chile (1)
GSK Investigational Site
Santiago
Colombia (1)
GSK Investigational Site
Bogotá
France (1)
GSK Investigational Site
Bordeaux
Germany (1)
GSK Investigational Site
Berlin
Greece (1)
GSK Investigational Site
Athens
Ireland (1)
GSK Investigational Site
Dublin
Italy (1)
GSK Investigational Site
Milan
Mexico (1)
GSK Investigational Site
Chihuahua City
Netherlands (1)
GSK Investigational Site
Utrecht
Peru (1)
GSK Investigational Site
Iquitos
Poland (1)
GSK Investigational Site
Szczecin
Puerto Rico (1)
GSK Investigational Site
San Juan
Romania (1)
GSK Investigational Site
Bucharest
Russia (1)
GSK Investigational Site
Irkutsk
South Africa (1)
GSK Investigational Site
Auckland Park Johannesb
Spain (1)
GSK Investigational Site
Badalona
Taiwan (1)
GSK Investigational Site
Taipei
United Kingdom (1)
GSK Investigational Site
Bournemouth
United States (1)
GSK Investigational Site
Los Angeles , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.02.2015
Completion date
30.09.2026
Registry ID
NCT02362503
Source
anzctr
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