Study 202

1. What is cenicriviroc (CVC)?
2. What is the purpose and design of CVC Study 202?
3. Who is eligible to participate in the trial to receive cenicriviroc (CVC)?
4. What are the side effects of cenicriviroc (CVC)?
5. Can I switch from my current HIV therapy to this new investigational medicine?
6. What will my participation in CVC Study 202 involve?
7. How will treatment be administered in the trial?
8. Are the other drugs in CVC Study 202 approved for HIV? What are they?
9. What is informed consent?
10. Is there a cost associated with participating in the trial? Will I be paid to participate in the trial?
11. Where is the trial being conducted? How can I find a trial nearest to me?
12. Who is sponsoring the trial?

1. What is cenicriviroc (CVC)?
Cenicriviroc is an HIV entry inhibitor that is in a class of anti-HIV drugs called CCR5 co-receptor antagonists. HIV, which particularly targets cells that fight infection (immune cells), needs to bind to certain co-receptors or "pockets" (called chemokine receptors) on the cell surface of immune cells (called CD4 or "T" cells) in order to enter the cell and establish HIV infection. There are two types of receptors on the CD4 cell surface: CCR5 and CXCR4. Cenicriviroc binds to and blocks HIV from attaching to the CCR5 co-receptor, preventing the virus from entering the cells. Most treatment-naïve people have the virus that uses the CCR5 pathway to enter their cells (CCR5-tropic).

Cenicriviroc also binds to a receptor called CCR2, also found on the cell surface of different kinds of cells, called macrophages and monocytes. These cells are involved in inflammation, which is the body's natural response to fight "foreign" invaders (such as bacteria or viruses) and infection before they can cause disease. However, sometimes the inflammatory response gets out of control and causes health problems, especially if untreated. Inflammation is linked to the development of heart and blood vessel disease (such as clogged arteries, heart attacks and stroke), and other types of diseases, such as arthritis, diabetes, kidney disease, some memory and thinking problems (focus, forgetfulness, difficulty processing information), bone loss and other serious diseases. HIV-infected patients tend to get some of these diseases and conditions at a younger age than healthy people. When cenicriviroc binds to CCR2, it may reduce some of the inflammation response that may be linked to some of these diseases. It is hoped that long-term CVC treatment for HIV may also lessen or slow the start of these diseases.

2. What is the purpose and design of CVC Study 202?
CVC Study 202 is a multi‐center, double‐blind, double‐dummy, 48‐week comparative study designed to evaluate the efficacy, safety and tolerability of CVC in 150 HIV‐1‐infected, antiretroviral treatment‐naïve patients with only CCR5‐tropic virus.

Participants will receive either once-daily 100-mg or 200-mg doses of CVC in combination with Truvada® (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF), or once-daily Sustiva® (efavirenz, or EFV) plus Truvada. The trial's primary objective is to determine the efficacy, safety and tolerability of each CVC regimen versus the comparator regimen. The primary study analyses will be performed at Week 24; the secondary analyses at Week 48. Additionally, several substudies will assess changes in biomarkers associated with inflammation, cardiovascular function, metabolic indicators of glucose control and immune function.

3. Who is eligible to participate in the trial to receive cenicriviroc?
There are several requirements for participating in CVC Study 202. The main ones are as follows:

You're 18 or over
You have a viral load of 1,000 copies/mL or higher
You have a CD4 count of 200 cells/mm³ or higher
You use effective contraception

You won't be eligible to participate if, among other considerations:

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

4. What are the side effects of cenicriviroc (CVC)?
In previous clinical studies to-date, CVC has demonstrated potent viral suppression and CCR2 inhibition, with a good safety and tolerability profile. The drug has been generally well tolerated; most adverse events (AEs) were mild, and there were no indications of a dose relationship through the 100-mg dose.

5. Can I switch from my current HIV therapy to this new investigational medicine?
No. Only persons with HIV-1 infection who have not yet begun a treatment regimen are eligible to participate in CVC Study 202.

6. What will my participation in CVC Study 202 involve?
If you qualify for CVC Study 202, you will need to attend all your visits at the study clinic for the duration of the study, which is expected to last for approximately 12 months. You will need to provide a complete medical history, have regular physical exams, give blood and urine samples, and have electrocardiograms (ECGs). Between visits you will need to keep careful track of your health and take the study medications as instructed by the study staff. All study-related office visits, exams, labs and medications will be provided at no cost to study participants.

7. How will treatment be administered in the trial?
Participants will receive either once‐daily 100-mg or 200-mg doses of CVC in combination with Truvada® (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF), or once-daily Sustiva® (efavirenz, or EFV) plus Truvada.

8. Are the other drugs in CVC Study 202 approved for HIV? What are they?
Truvada (from Gilead Sciences) and Sustiva (from Bristol-Myers Squibb) are commonly prescribed in combination for treatment of HIV.

9. What is informed consent?
Informed consent is a process that ensures you understand all aspects of the clinical study. You will be asked to read and sign an informed consent document derived from the specific information about the clinical trial and how it may affect you. By signing the informed consent form, you indicate your willingness to participate in the study. Processes and procedures are in place to protect your privacy.

10. Is there a cost associated with participating in the trial? Will I be paid to participate in the trial?
No, there is no cost to participate in trial. You will not be paid to participate in the trial.

11. Where is the trial being conducted and where can I find a trial site nearest to me?
There are approximately 50 trial sites across the United States and Puerto Rico currently screening patients for enrollment.

Click here to find a participating site near you.

12. Who is sponsoring the trial?
The trial is sponsored by Tobira Therapeutics, a biotechnology company focused on developing and commercializing innovative antiviral compounds to treat HIV infection.