Our Observational Study is a non-interventional study, meaning that study participants are simply observed by agreeing to have their blood drawn for research purposes. We follow patients over the long-term in order to study their immune systems and viruses throughout the course of disease.
So that we can learn about the early events of HIV infection, we enroll patients who are identified during the acute or early stage of infection. During acute infection, standard HIV testing is usually negative or only partially positive, also known as an indeterminate test result. These tests measure the presence of antibodies (proteins), which usually do not appear until several weeks after infection. An HIV viral load test measures the amount of virus present in the blood, and persons with acute infection usually have very high levels of virus in their blood. Someone who has early HIV infection has had a negative HIV test within the past 12 months but who now tests HIV positive.
Without the help of our dedicated study participants, it would be impossible for us to better understand how the body first responds to HIV.
If you have been diagnosed with acute HIV infection in the past 12 months and are interested in learning more about our Observational Study, please feel free to contact us for more information:
Sue Bazner, head study nurse at MGH: 617.724.0070.
Jake Tinsley, research associate at Fenway Health: 617.927.6085.
Bill Theisen, study nurse at Brigham and Women's Hospital: 617.732.8881.
Kimberly Lane, project manager at the Ragon Institute: 617.643.9701.
The important question of whether or not to treat individuals with highly active antiretroviral therapy (ART) during acute HIV infection remains unresolved to date.
This Clinical Trial will determine whether treatment that is initiated during the acute phase of HIV infection, followed by discontinuation of treatment, is effective in decreasing the amount of HIV and increasing the number of CD4+ T cells in the blood of people with HIV, compared to the amounts of HIV and CD4+ T cells in those who do not receive treatment at this stage.
To participate in the Clinical Trial, you must meet the following criteria:
- Age 18-60.
- Females must not be pregnant.
- Acute HIV infection must be confirmed by lab testing.
- Able and willing to give informed consent.
You may not participate in this study if:
- You have received an experimental vaccine.
- You have taken any immunosuppressant medications within the past 6 months.
- You are currently being treated with anti-TB prophylaxis or therapy.
If you are interested in learning more about the Clinical Trial, please contact Sue Bazner, clinical trial specialist, at 617.724.0070. She will talk more with you about the Trial and answer any questions you may have. If you agree to participate, some additional tests will be conducted to determine if your current symptoms are due to newly acquired HIV infection. Experienced staff will follow and support you closely, as you will have regular visits with the study nurse for at least one year.