A5354: Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses

Will evaluate whether starting antiretroviral drugs very early in HIV infection will limit the virus from getting into hidden areas of the body (reservoirs) and change how the immune system helps to control the virus.

This study will include people who have very recently been infected with HIV and will start anti-HIV (antiretroviral) drugs right away to see how this may change HIV’s impact on the body.

This study is trying to find out if starting antiretroviral drugs very early in HIV infection will change the following:

• Limit the virus from getting into hidden areas of the body (“reservoirs”).
• Change how the immune system helps to control the virus.

What we mean by very early is even before the blood shows that antibodies have been made, or just at the time antibodies are starting to be found in the blood.

Men and women who:

• Are at least 18 years old
• Have had certain lab tests done that confirm very early HIV infection
• Are willing to take antiretroviral drugs right away to treat HIV.

Participants will start elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) single-tablet regimen (often called “Genvoya”) within 24 hours but no later than 48 hours after entering the study.

Blood tests will be done at all clinic visits to check HIV blood levels and immune cells.

Some participants may be approached to take part in additional optional procedures later in the study to check out the “reservoirs” where the virus might hide:

• Leukapheresis or large volume blood collection
• Lumbar puncture (cerebrospinal fluid) (also called a “spinal tap”)
• Gut biopsy (also called “sigmoidoscopy with biopsy”)

The study treatment that will be provided through the study is EVG/COBI/FTC/TAF single-tablet regimen. Other antiretroviral drugs are allowed if EVG/COBI/FTC/TAF is not the ideal drug for a particular person.

The duration of the study is up to 72 weeks (a year and a half).