A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose

TerminadoFase 2ClinicalTrials.gov

ID: NCT01489046Tipo: INTERVENTIONALInicio: 1 de feb de 2011Fin estimado: 1 de jul de 2014

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

Descripción detallada

Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)
Plasma HIV-1 RNA \> 5000 copies/mL
Antiretroviral treatment-naive; defined as no current or previous exposure to \> 1 week of an antiretroviral drug
CD4+ T-cell count \> 200 cells/mm3

Criterios de exclusión

Resistance to any of the study medications \[Tenofovir Disoproxil Fumarate(TDF), Efavirenz (EFV), Lamivudine (3TC)\] or to HIV Protease Inhibitors (PIs)
Contraindications to any of the study drugs

Intervenciones

drug

BMS-986001

Capsules, Oral, 100 mg, Once daily, At least 48 weeks

drug

BMS-986001

Capsules, Oral, 200 mg, Once daily, At least 48 weeks

drug

BMS-986001

Capsules, Oral, 400 mg, Once daily, At least 48 weeks

drug

Placebo matching with BMS-986001

Capsules, Oral, 0 mg, Once daily, At least 48 weeks

drug

Efavirenz

Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase

drug

Lamivudine

Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase

drug

Tenofovir

Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase

Ubicaciones

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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