July 5, 2011
Tobira Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies for HIV, announced on June 23 that it has initiated a Phase 2b clinical trial for the CCR5/CCR2 inhibitor cenicriviroc (TBR-652).
"The multi-center, double-blind, double-dummy, 48-week comparative study is designed to evaluate the efficacy, safety, and tolerability of cenicriviroc in 150 HIV1-infected, antiretroviral treatment-naive patients with only CCR5-tropic virus," the press release said. The trial is actively enrolling patients in more than 50 sites across the United States and Puerto Rico.
Participants will receive either once-daily 100 mg or 200 mg doses of cenicriviroc in combination with emtricitabine/tenofovir disoproxil fumarate (Truvada), or once-daily efavirenz (Sustiva) plus Truvada. The trial's primary objective is to determine the efficacy, safety, and tolerability of each cenicriviroc regimen versus the Sustiva regimen. Additionally, several sub-studies will assess changes in biomarkers associated with inflammation, cardiovascular function, metabolic indicators of glucose control, and immune function.
The new study is based on the strength of the cenicriviroc Phase 2a proof of concept, pharmacokinetic, and safety findings that were presented at key HIV/AIDS conferences and published in peer-reviewed journals, according to Melanie Thompson, MD, of the AIDS Research Consortium of Atlanta, and a lead investigator in the new study. "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 HIV1-infected patients," she added.
For more information on the Phase 2b trial of cenicriviroc, visit clinicaltrials.gov.