Harborview Medical Center

325 9th Avenue

2nd Floor West Clinic

Seattle, WA 98104

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The TRIPLE ANTIBODY Study

This study is looking for people living with HIV who have never taken ARVs  and have a CD4 count above 350 and HIV viral load between 5,000 and 100,000, and are willing to start ARVs by day 28 of the study.

About this Study

This study will evaluate the safety and  effectiveness of an investigational monoclonal antibody given by infusion, SAR441236 (versus placebo in ARM A).

 

The study will also see if  SAR441236 can reduce HIV in a person’s blood and measure the antibody in blood over time.

Both people with well controlled HIV infection (Arm A) and those with HIV infection not on antiretroviral therapy (ART) (Arm B) will be enrolled. People not on ART will begin medications within 28 days.

 

ARM A: Participants will be randomized (like flipping a coin) to receive SAR441236 or a placebo.  One group will receive an infusion/placebo every 12 weeks x 4. This arm is now full!

ARM B: All participants will receive SAR441236 and begin ARVs by day 28. 

 

Requirements to Enter Study:

  • People living with HIV

  • Age 18 or older and under age 70

  • Routine labs within normal limits (kidney & liver tests)

  • No active Hepatitis B or C

  • Not pregnant nor breastfeeding, and must agree to use approved birth control if indicated.  

  • ARM A only (this arm only has been filled)

    • On Antiretroviral therapy (ART) for at least 12 months

    • CD4 count over 200

    • Suppressed HIV viral load

  • ARM B only

    • Never have taken ART

    • CD4 count over 350

    • HIV viral load over 5,000 and less than 100,000

    • Willing to start ART on Day 28 of the stud

 

  • No other monoclonal antibodies (MAB) within 6 months or 12 months for long acting MAB

 

Length of Study:  Approximately 24 - 72 weeks

 

Schedule of Study Appointments: Screening, Entry with 10 hour blood draw

     Arm A – Pre-entry, Day 1, 2, 3, Weeks 1, 2, 4, 8, 12, 24

     Arm A multi-dose group – 10 hour blood draw repeated at week 36. Infusions with                      similar visit schedule as above for Arm A repeated every 12 weeks.

   

     Arm B - Day 1, 2, 3, 4, 10   Weeks 1, 2, 3, 4, 8, 12, 24. 

 

Medications administered during study:  SAR441236 infusion given through vein. Arm A may receive placebo. SAR441236 is investigational.

 

Study Procedures:  Medical histories, Physical exams, Blood draws, Infusions

 

Reimbursement:  $20 per visit starting at Entry, $100 per visit for infusion visits

 

Contact:  ACTU Screening Nurse at either 206-744-8883 (phone) or 206-733-7129 (text)