A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults

TerminadoFase 2ClinicalTrials.gov

ID: NCT02415595Tipo: INTERVENTIONALInicio: 12 de may de 2015Fin estimado: 21 de ago de 2017

Enfermedades Infecciosas Alergia e Inmunología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Men and non-pregnant women, at least 18 years of age
Antiretroviral treatment-naïve; defined as no current or previous exposure to \> 1 week of an antiretroviral drug
Plasma HIV-1 RNA ≥ 1000 copies/mL
CD4 T-cell count \> 200 cells/mm3

Criterios de exclusión

Resistance or partial resistance to any study drug determined by tests at Screening
Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors
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

EFV

drug

TDF/FTC

Ubicaciones

GSK Investigational Site

Ciudad Autonoma 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

Patrocinadores

PrincipalViiV Healthcare

ColaboradorGlaxoSmithKline

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