The INJECTABLES PLUS Study
We are looking for everyone living with HIV with a suppressed viral load for at least 2 years to volunteer for an investigational study to see if a combination of an injectable HIV medicine plus a monoclonal antibody drug given intravenously will maintain suppression of viral load.
About this Study
This study is trying to find out if a combination of an investigational HIV drug (cabotegravir) and a monoclonal antibody (VRC07-523LS) would be safe and effective at maintaining an undetectable viral load when given as injectable long-acting agents in people living with HIV.
Step 1: Participants will start taking oral cabotegravir with two NRTIs (part of their current HIV treatment regimen) for 4 weeks.
Step 2: If the viral load is still undetectable at the week 4 visit, they will stop their baseline HIV regimen and oral cabotegravir and begin receiving cabotegravir intramuscular injections every 4 weeks along with VRC07-523LS antibody infusions every 8 weeks for 40 weeks.
Step 3: They will then be followed for another 48 weeks while back on a standard HIV treatment regimen.
Participants will have the study drugs administered at our clinic along with blood draws to measure the viral load and the amount of study drug in the body.
Length of Study: 101 weeks (about 5 weeks in Step 1; then 48 weeks in Step 2; followed by 48 weeks in Step 3)
If their viral load becomes detectable, participants will stop the study treatment and be closely monitored.
Main Requirements to Enter Study:
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People living with HIV
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18 years of age or older
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Currently stable on a conventional ART regimen (ie, an integrase inhibitor, NNRTI, or boosted PI plus two NRTIs).
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Cannot have switched ART due to failure of the medications
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No detectable HIV virus for at least 2 years
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CD4 count above 350
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No Hepatitis B or C infection
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No history of seizures or severe allergic reaction within past 2 years
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Cannot be pregnant, breastfeeding, or planning to get pregnant
Medications administered during study:
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Oral cabotegravir for 4 weeks
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Cabotegravir given as an injection with VRC07-523LS given as an infusion for 40 weeks
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Then standard HIV treatment for 48 weeks (not provided by the study)
Study Procedures:
Medical histories, questionnaires, physical exams, blood draws, and injections (a shot given in the muscle) and infusions (given through vein in the arm)
Reimbursement:
$20 per visit starting at the Screening Visit
and $50 per infusion
Contact:
ACTU Screening 206-773-7129 (call or text)
