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The Setpoint Study (Study A5217)
A randomized study comparing immediate treatment vs. treatment as indicated in newly-infected HIV-positive patients
by the A5217 Study Team

Why is this study being done?

This study is being done by the AIDS Clinical Trials Group (ACTG) to learn if treating people during early HIV infection is beneficial. Researchers want to know if taking anti-HIV medication immediately following infection is better than waiting to start medications until the HIV infection has progressed.

Studies have shown that treatment of HIV lowers the chance of death, improves quality of life and lowers the chance of opportunistic infections for HIV-infected patients. However, the use of these medications also has side effects such as raising cholesterol, raising the sugar level in your blood, a possible abnormal fat distribution and possible liver damage. These side effects are always considered when people decide whether or not to begin anti-HIV treatment. Most people infected with HIV wait to start treatment until after they have been infected for a while.

Based on recent studies, there are some data to suggest that treating people early after their infection may be of some benefit. The part of the immune system that fights HIV infection may stay healthier if treatment is begun early. People who are treated early and then stop treatment may be able to control the virus better than if they had not been treated early. Early treatment may also lower the chance of spreading the infection to another person.

However, early treatment also poses risks. People may be exposed to medications and their side effects and inconveniences for a longer period of time. Also, if medications are not taken correctly, resistance to the medications can occur, making it less likely that medications will work as well later in one’s life.

We do not know if beginning treatment earlier than normal outweighs the risks. We do not know whether or not treating early HIV infection makes a difference in the long-run in terms of keeping you healthier longer. That is what this trial will try to discover.

What will happen in this study?

During this study, one group of people will immediately begin taking anti-HIV drugs (Truvada once daily plus Kaletra twice daily) for nine months. The second group will start treatment only when their CD4 T-cell count goes low or their viral load stays high, or if they develop certain symptoms related to HIV disease.

At the end of the study, the amount of HIV in persons who received anti-HIV drugs at the beginning of the study and then stopped the anti-HIV drugs will be compared to the amount of HIV in persons who did not start anti-HIV drugs, to see if the persons who received the nine months of treatment have a lower amount of HIV. We do know that persons who have less HIV in their blood tend to do better than persons with higher amounts of HIV.

Some rules

In this study, you cannot choose to start treatment or wait. You will have a 50/50 chance, as if by the toss of a coin, to immediately begin treatment for nine months, or to delay treatment until your HIV disease has progressed (which is when most people start treatment). You must also be willing to stop treatment after nine months if you are in the treatment arm.

It is very important for you to know that during the study, anyone who needs treatment for HIV because of high viral load, immune system decline or symptoms related to HIV infection will be offered treatment.

For more information on the study, please contact Dr. Christine Hogan at 1–414–223–6843, or send her an e-mail at ch358@columbia.edu. Visit www.clinicaltrials.gov for more information, including a list of study sites.
 

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