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news.Tobira Therapeutics, a developer and commercializer of antiviral compounds to treat HIV infection, has started a Phase IIb double-blind, multi-center 48-week comparative study of the CCR5/CCR2 inhibitor cenicriviroc (TBR-652).
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The study aims to assess the efficacy, safety and tolerability of cenicriviroc versus the comparator regimen in 150 HIV-1-infected, patients with antiretroviral treatment-naive with only CCR5-tropic virus.
In the trial, the patients will be given either once-daily 100mg or 200mg doses of cenicriviroc in conjunction with emtricitabine/tenofovir disoproxil fumarate (Truvada), or once-daily efavirenz (Sustiva) plus Truvada.
The AIDS Research Consortium of Atlanta Melanie Thompson said the study will further explore cenicriviroc’s antiviral activity and safety as well as effects on immunologic and inflammatory biomarkers, including the effects of CCR2 receptor inhibition in HIV-1 infected patients.
Tobira president and CEO Andrew Hindman said this study will establish the optimal dose, evaluate the antiviral activity, safety and tolerability and advance the understanding of the role CCR2 blockade may have in mitigating some of the co-morbidities associated with HIV infection.