Study 202

Tobira Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies for HIV, has initiated a Phase 2b clinical trial of the CCR5/CCR2 inhibitor cenicriviroc (CVC, TBR 652).

Participants in the trial – CVC Study 202 – will receive either once-daily 100-mg or 200-mg doses of cenicriviroc in combination with Truvada® (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF), or once-daily Sustiva® (efavirenz, or EFV) plus Truvada. The study's primary objectives are to determine the efficacy, safety and tolerability of each CVC regimen versus the comparator regimen. Additionally, several substudies will assess changes in biomarkers associated with inflammation, cardiovascular function, metabolic indicators of glucose control and immune function.

The study lasts for one year and provides study medications at no charge, along with study-related exams and lab tests.

Patient eligibility is based on a number of criteria including but not limited to the following:

Must be 18 years of age or older
Must have a viral load of 1,000 copies/mL or higher
Must have a CD4 count of 200 cells/mm³ or higher, with no CD4 count ever less than 200 cells/mm³
All study participants must be willing to take appropriate pregnancy-prevention precautions

Patients are not eligible if, among other considerations:

They have ever been treated for HIV/AIDS in the past
They have ever had a CD4 count of less than 200 cells/mm³
They have tuberculosis, hepatitis B or C or cirrhosis of the liver