We use the term "Acute HIV infection" or "Primary HIV infection" to describe the illness that takes place shortly after a person is exposed to HIV and becomes infected with HIV. After the exposure, the virus enters spreads throughout the body, multiplying in various organs and tissues. During this period the amount of virus in the blood (viral load) can rise to very high levels (often, millions of viruses per milliliter of blood). The virus infects the CD4 T cells (a type of cell that fight infections) and as a result the number of these T cells in the body declines. During acute HIV infection, a person may test negative on the standard HIV test, because he/she has not yet produced antibody to HIV; however, the HIV viruses will be present in the blood and the viral load test will be positive.
Enlarge Image. Diagram by Linda Apuzzo
We use the term “Seroconversion” to describe the development of antibody to HIV. When a person becomes infected with HIV, that person “converts” from not having antibodies to HIV, to having such antibodies. As the body is beginning to make antibodies to HIV, a person may test “indeterminate” (that is, not clearly positive but not clearly negative, either) on an HIV test. HIV Seroconversion may be associated with flu-like symptoms, though many people have no symptoms at all. The period between exposure to HIV and seroconversion is variable, but most people will test positive within several weeks of exposure.
In HIV seroconversion, the most common symptoms are fatigue, fever, sore throat, body aches, rash, headache, and swollen lymph nodes; people often think that they have the “flu”. While some people may feel so sick that they go to see a doctor, others will have no symptoms at all. If present, symptoms may last between several days and several weeks. People who seek medical care at this time should notify their doctors that they may be at risk for HIV.
It is easier to transmit HIV during seroconversion than at other stages of HIV infection. This is because the amount of HIV in the body during this time is very high. These days, many people who are diagnosed with HIV have been infected by someone who did not know that he or she was positive. If you have just found out that you are positive, it is important to contact all of your partners to let them know there is a possibility they may be HIV-positive, and if so may benefit from treatment. They can find out if they are HIV-positive by getting tested for HIV.
One way is if you have a negative HIV test within the past year, you would be considered recently infected by our study guidelines. If you haven't had a negative test within the past year but believe you may have been infected recently, there is a test we can do that may tell us if you have been infected within the last six months. This is called a “detuned antibody test” and it is available only through research studies.
The main risks of the study are the risks associated with the medicines used to treat HIV infection. This study only uses medications that are licensed by the Food and Drug Administration (FDA) to treat HIV (approved drugs). The side effects of these medications are well known and the study team will discuss the potential side effects of any medication they are considering for you in advance. The side effects are expected to be minimized in this study because the medications will be given for only one year.
Yes. You can leave the study at any time, for any reason.
Once you enroll you are seen every month for the first year, then every 3 months for the next two years.
You can still be in the study. The study staff are very flexible and can see you as early as 7:00 AM and as late as 6:30 PM during week days. They will give you a doctor’s note for school/work if you need it.
Most visits usually take about ½ hour (this includes the time to draw blood). The first two visits will be longer because we will be explaining the study and answering all of your questions; usually 1- 2 hours.
You will receive $15 at each study visit. All lab tests are provided free of charge.
The most important criterion for being eligible for the study is documentation that HIV infection has been acquired within the last 12 months. Some of the other entry criteria are listed below.
Documented acute or early HIV infection: (negative HIV test within the last 12 months, or positive “detuned” HIV test, or positive HIV viral load test with a negative or indeterminate HIV antibody test)
No previous use of medicines to treat HIV infection
Be able to swallow tablets or capsules
Be willing to use acceptable forms of contraception
Be willing to be randomized to either take 12 months of treatment or to wait until they meet current guidelines for starting treatment
People with less than 250 t-cells
Note: Other criteria may apply.
You can find out more about HIV and AIDS, including the current guidelines for HIV treatment at the U.S. Department of Health and Human Services website
If you have any questions regarding the study, please email or call
Linda Apuzzo (410) 614-7796 or
Hejab Imteyaz (410) 502-8053