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COBI

Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Ensayo de GILEAD SCIENCES, INC. en HIV-1 Infection (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

85

previstos

Centros

31

Fin del objetivo primario

dic 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en may 2009.

Qué mide

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (del registro, en inglés) (semana 24)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.

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Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00892437), actualizada en ene 2016.