A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment Naive HIV-Infected Subjects

TerminadoFase 2ClinicalTrials.gov

ID: NCT00768989Tipo: INTERVENTIONALInicio: 1 de nov de 2008Fin estimado: 1 de may de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Human Immunodeficiency Virus (HIV)-1 positive status
HIV ribonucleic acid (RNA) level \>=5000 copies/mL
Antiretroviral treatment-naive
Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following criteria:
\<350 cells/mm\^3
Screening CD4 \>=350 and \<=500 cells/mm\^3 ONLY if at least 1 of the following conditions apply:
Screening HIV RNA level \>100,000 copies/mL, or
CD4 decline \>50-100 cells/mm\^3/year, or
Age \>=55 years
Any CD4 cell count, if participant has a history of an acquired immune deficiency syndrome-defining illness
Medically stable

Criterios de exclusión

Screening HIV genotype showing resistance to any component of the study regimen (Atazanavir, Raltegravir, Tenofovir/Emtricitabine)
Hepatitis B or hepatitis C coinfection
History of or current cardiac disease
Electrocardiogram findings:
PR Interval \>260 msec (severe 1st degree atrioventricular block)
QRS Interval \>120 msec

Intervenciones

drug

Atazanavir

Capsules, Oral, 300 mg, once daily, 96 weeks

drug

Ritonavir

Capsules, Oral, 100 mg, once daily, 96 weeks

drug

Tenofovir/Emtricitabine

Tablet, Oral, 300-mg Tenofovir/200-mg Emtricitabine, once daily, 96 weeks

drug

Atazanavir

Capsules, Oral, 300 mg, twice daily, 96 weeks

drug

Raltegravir

Tablet, Oral, 400 mg, twice daily, 96 weeks

Ubicaciones

Local Institution

Buenos Aires, Bs As, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorMerck Sharp & Dohme LLC

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