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The EARLIER Study

The UW AIDS Clinical Trials Unit is looking for men and women who have been infected with HIV within the past 1-2 months who are willing to take drugs to treat HIV right away to volunteer for an investigational study to see if starting HIV meds very early in infection limits the HIV reservoir or changes how the immune system helps to control the virus.

The study is trying to find out if starting antiretroviral therapy very early in HIV infection will:

  • Prevent or decrease the amount of virus getting into hidden areas in the body (reservoirs)

  • Change how the immune system reacts to the virus (tries to control it)

“Very early” means before or just as antibodies to HIV are detectable in the blood.

Determining the impact of antiretroviral therapy (ART) during acute infection on the HIV reservoir and residual viremia has been limited by the number of people studied, as well as by the tests used to detect HIV.

 

A  study is needed to define the impact of early ART on virologic and immunologic outcomes that are relevant to achieving HIV cure.

 

The goal of the study is to see if starting HIV meds very early in infection limits HIV reservoirs or changes how the immune system helps to control the virus.

 

Length of Study: 

 

Approximately 72 weeks

 

 

Schedule of Study Visits:

 

Screening, Entry, and weeks 1, 2, 4, 8, 12, 24, 36, 48, 49, 60 and 72 

 

 

Medications Provided during Study:

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  • Study will provide Genvoya®  (elvitegravir/cobicistat/tenofovir [TAF]/emtricitabine)

  • Other antiretrovirals can be used instead if this is not the ideal regimen for a participant.

 

 

Study Procedures:

 

Clinical assessments, blood draws, questionnaires, some phone calls

 

Some people may be asked to have one or more optional procedures per year into the study to check out the reservoirs where the virus might hide. 

 

These procedures are not required for participation in the study and will involve additional compensation.

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Reimbursement: 

 

Participants will receive $20 per visit starting at Entry (and additional compensation if they undergo any of the optional procedures.)

 

You May be Eligible for this Study if you are:

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  • At least 18 years old

  • Willing to take drugs to treat HIV right away.

  • Have certain lab tests done that confirm very early infection.

  • Willing to sign the consent after discussion with the research staff

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Contact: 

Janine Maenza, MD at 206-667-5743 

or ACTU Screening Nurse at 206-773-7129

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