EMBRACE: Efficacy of Monoclonal anti-Body Regimen VH3810109 And CabotEgravir

Study Flyer with brief description and eligibility criteria

 

Brief Description:  

A study to investigate the virologic efficacy and safety of VH3810109 + Cabotegravir compared to 

Standard of Care in male and female adults living with HIV 

Purpose of study:  

This study is being done to learn more about the study drug, VH3810109, in combination with cabotegravir (CAB), a medicine already approved for HIV. Researchers want to see whether the combination of these 2 drugs can maintain a low amount of HIV virus inside the body. This study will compare the effects of the study drug with those of the current standard treatment for HIV. 

Major requirements for entering the study (things that must be true for you): 

  • 18 to 70 years of age. 

  • Diagnosed with HIV-1. 

  • Have been taking oral HIV medications for at least one year. 

  • Have never been on long-acting HIV therapy, including injectable HIV medications. 

  • Have had an undetectable viral load for at least one year. 

  • Do not have active hepatitis B 

  • Have never been told your HIV medications were not working. 

Intervention:  

  • To determine whether you qualify, the study doctor will collect information about your health and run some tests. 

  • If you qualify, you’ll be placed by chance into a group to receive either the study drug + CAB or standard HIV treatment for 2 years. Your chances of receiving the study drug are 4 times greater than your chances of receiving standard treatment. 

  • You will have visits at the study site for treatment and tests to check on your health. 

Procedures:  

  • If you are assigned to arm 1: You will receive monthly intramuscular injections of cabotegravir and an intravenous infusion through your arm of the investigational drug every four months. We will also collect blood samples throughout your study visits.  

  • If you are assigned to arm 2: You will receive monthly intramuscular injections of cabotegravir and a subcutaneous infusion   of the investigational drug through the layer of fat just under the skin of your abdomen every four months. We will also collect blood samples throughout your study visits. 

  • If you are assigned to arm 3: You will continue to take your standard of care medication regimen, and we will have you come in for blood sample collection and other study procedures throughout your participation. 

Duration of Study:  

24 months (about 2 years)  

Contact information:  

Clinical Research Coordinator: Lu Morales  

Email: [email protected]  

Phone number: 415-806-8554