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.
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
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On stable HIV treatment for a minimum of 2 years
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Undetectable HIV viral load
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CD4+ greater than 500
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Lowest CD4 count ever of 350
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Cannot have a cardiac pacemaker, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulator
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No current Hepatitis B or C infection
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No history of seizures or irregular heart rhythm
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No large tattoos over the upper arm
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No diabetes
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Weigh more than 110 and less than 440 pounds
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For women of reproductive potential - not planning pregnancy or pregnant
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No auto-immune diseases
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No history of cancer requiring chemotherapy in the past 5 years
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No HIV related opportunistic infections in the past 5 years
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Willing to have leukapheresis
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)
