The IMMUNE BOOSTER Study

We are looking for people living with HIV who have been undetectable

for at least 2 years to evaluate the safety and effectiveness of a new experimental HIV therapeutic vaccine and to see if it helps control HIV. 

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About this Study

 

 

This investigational study seeks to evaluate the safety and effectiveness of a new HIV vaccine. This vaccine is not meant to prevent HIV infection, but rather to improve how the immune system of HIV+ people responds to the virus. And so, we call this a therapeutic or treatment vaccine.

Participants will be randomized (like flipping a coin) to receive at  entry, 1 month, 3 months & 6 months one of the following:

     A.  A new HIV therapeutic vaccine (meant not to prevent HIV infection, but rather boost your body’s immune response), plus a booster shot with a traditional vaccine

     B.  Just the traditional vaccine alone

     C.  A placebo

Requirements

  • On stable HIV treatment for a minimum of 2 years

  • Undetectable HIV viral load

  • CD4+ greater than 500

  • Lowest CD4 count ever of 350

  • Cannot have a cardiac pacemaker, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulator

  • No current Hepatitis B or C infection

  • No history of seizures or irregular heart rhythm

  • No large tattoos over the upper arm

  • No diabetes

  • Weigh more than 110 and less than 440 pounds

  • For women of reproductive potential - not planning pregnancy or pregnant

  • No auto-immune diseases

  • No history of cancer requiring chemotherapy in the past 5 years

  • No HIV related opportunistic infections in the past 5 years

  • Willing to have leukapheresis

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Length of Study:  Approximately 48 weeks

 

Schedule of Study Appointments: Screening, Pre-Entry, Entry, Weeks 1, 4, 6, 12, 24, 26 and 48

 

Medications administered during study:  Vaccine (4 doses) or placebo vaccine

 

Study Procedures:  Medical histories, Physical exams, Blood draws, Questionnaires, Vaccines, 2 optional leukapheresis procedures

 

Reimbursement:  $20 per visit starting at Pre-Entry for non-vaccine visits, $25 per visit for each of the 4 vaccine visits, and $250 for each of the 2 leukapheresis procedures

 

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

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