A Phase 2B Multicenter, Randomized, Double-Blind, Comparative Trial Of UK-453,061, In Combination With Tenofovir Df And Emtricitabine Versus Efavirenz In Combination With Tenofovir DF And Emtricitabine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects

CompletadoFase 2ClinicalTrials.gov

ID: NCT00824421Tipo: INTERVENTIONALInicio: 1 de feb de 2009Fin estimado: 1 de oct de 2011

Traducción no disponible, mostrando original

Resumen

This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
HIV 1 RNA viral load of greater then 1,000 copies/mL
Negative urine pregnancy test.

Criterios de exclusión

Suspected or documented active, untreated HIV-1 related opportunist infection or other condition requiring acute therapy at the time of randomization.
Subjects with acute Hepatitis B and/or C within 30 days of randomization.
Absolute CD4 count \<200 cells/mm3.

Intervenciones

drug

UK-453, 061

UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

drug

UK-453, 061

UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

drug

EFV +TVA

Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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