This study is for people with HIV who have an undetectable viral load. The study will evaluate the safety and effectiveness of a combination of two medications. The first drug is called long-acting cabotegravir (CAB), which will be given orally at first and then as an injection every 4 weeks. The second drug is called VRC-HIVMAB080-00-AB (VRC01LS), which is a monoclonal antibody. A monoclonal antibody targets human proteins rather than attacking the virus directly. This drug will be given intravenously (directly into a vein, intravenous [or “IV”]) for about 15 to 30 minutes every 12 weeks.

Why is this study being done?

  • The study will see if cabotegravir and VRC01LS work well when taken together to keep HIV levels low.
  • This study will also evaluate the safety of the drug combination.

Who can join?

People with HIV

  • Between the ages 18 and older
  • On stable anti-HIV medications for a minimum of 8 weeks
  • With a CD4+ cell count greater than or equal to 350
  • Having an undetectable HIV viral load (less than 40 copies)
  • With no current Hepatitis B or C infection
  • With no history of seizures or treatment for seizures within the past 2 years
  • With a susceptibility to VRC01LS based on assay done at screening

What do I need to do in the study?

Participants will be registered to three “steps”:

Step 1: All participants will discontinue their current anti-HIV medications except for “nukes” and start oral CAB.

Step 2: Participants may receive CAB long-acting drug by injection every 4 weeks, plus VRC01LS infusion by IV every 12 weeks.

Step 3: Participants will be switched back to a standard-of-care oral HIV regimen.

Duration of study: Participants will be on study for about 101 weeks.

What treatments or drugs are involved with this study?

The study provides oral and long-acting injectable cabotegravir and VRC01LS infusions.  Standard-of-care oral medications will be locally sourced.

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