A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults

TerminadoFase 2ClinicalTrials.gov

ID: NCT02386098Tipo: INTERVENTIONALInicio: 8 de jul de 2015Fin estimado: 7 de jun de 2017

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) \[with or without ritonavir (RTV)\] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men and non-pregnant women, at least 18 years of age
Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or without documented resistance)
CD4+ T-cell count \> 50 cells/mm3
Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC \< 2.2; DTG; TDF)

Criterios de exclusión

Antiretroviral treatment-experienced adults who have failed \> 2 ARV regimens
Resistance or partial resistance to any study drug determined by tests at Screening
Historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs
Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)
Blood tests that indicate normal liver function
Hemoglobin \< 8.0 g/dL, Platelets \< 50,000 cells/mm3

Intervenciones

drug

BMS-955176

HIV Maturation Inhibitor

drug

Atazanavir (ATV)

Atazanavir

drug

Ritonavir (RTV)

Ritonavir

drug

Dolutegravir (DTG)

Dolutegravir

drug

Tenofovir (TDF)

Tenofovir

Ubicaciones

GSK Investigational Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Mar del Plata, Argentina

Patrocinadores

PrincipalViiV Healthcare

ColaboradorGlaxoSmithKline

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 2b Randomized, Active-Controlled, Staged, Open-La... | EligiMed