About

Study Explanation

Strategies for Management of Anti-Retroviral Therapy (SMART) is a research study looking at two different ways of treating HIV to find out which works best for patients over a long period of time. Six thousand HIV-infected individuals with a CD4+ cell count greater than 350 cells/mm3 will be enrolled over a 3-5 year period. Study participants will be followed for 6 to 9 years to try to answer some very important questions.

Main Study Questions

  • Is it better to GO ahead and use anti-HIV medicines continuously to keep the amount of virus in the blood as low as possible (no matter what the CD4+ cell count is)? OR
  • Is it better to WAIT and NOT use anti-HIV medicines during times when the CD4+ count is higher and the risk of getting sick from HIV is low?

Background

Great progress has been made in treating HIV, the virus that causes AIDS. Today, we have medicines that can help control the virus. These medicines slow down HIV disease for many people, at least in the short term. Yet, there is still so much we don’t know. For example:

  • How long will the effects of these medicines last?
  • When is the best time to start taking these medicines?
  • What are the pros and cons of taking these medicines
    over a long period of time?

Did you know that most of what we know about treating HIV has come from short term studies? It is certainly true that we have come a long way in understanding and treating HIV; however, the answers to the rest of our questions will come from studies that must last for many years. The purpose of the SMART Study is to help find these answers.

Study Requirements

To participate you must:

  • Have evidence of HIV infection
  • Be over 13 years old
  • Have a CD4+ cell (T cells) count greater than 350 cells/mm3
  • Be willing to initiate, modify, or stop antiretroviral therapy, according to the study group to which you will be assigned.
  • Not be currently pregnant or breastfeeding
  • Sign an informed consent

Study Routine

In this study participants are selected by chance (as with the toss of a coin) to be part of either the GO Group or the WAIT Group.

The GO Group
(also called the Viral Suppression Group)

  • If you are selected for the GO Group, you will take anti-HIV medicines continuously while you are in the study to keep the amount of virus in your blood as low as possible.

  • If you are taking anti-HIV medicines when you start the study, you must continue taking anti-HIV medicines. These may be the same medicines, or you and your study provider might decide to change your medicines.

  • If you are not on anti-HIV medicines, your study provider will start you on them.

The WAIT Group
(also called the Drug Conservation Group)

  • If you are selected for the WAIT Group, you will wait and NOT use anti-HIV medicines until the risk of getting sick is higher. 

  • If you are already taking anti-HIV medicines, your study provider will tell you to stop taking them.

  • The risk of getting sick is greatest when your CD4+ cell count is below 100. In this study if your CD4+ cell count goes down to less than 250, your study provider will start you on anti-HIV medicines. You will take these medicines until your CD4+ cell count goes up to 350 or more, when the risk of getting sick is lower again. Then you will be asked to stop and wait again.

During the first year of the study, participants will visit their study provider about every 2 months. After the first year, study visits will be about every 4 months.

At each visit participants will be examined and questions will be asked about their health and medicines. Blood will be taken to check CD4+ cell count and viral load. On some visits, blood may be taken for special tests.

  • Study providers will continue to see participants as often as needed to monitor their health status. This may be more often than indicated by the study.
  • When participants are being treated with anti-HIV medicines as part of this study, the participant and study provider may choose which anti-HIV medicines will be taken.

Please check with your healthcare provider or one of our study personnel if you have any questions regarding the study requirements or routine.

Sites

This international study is being conducted by the Community Programs for Clinical Research on AIDS (CPCRA), the Copenhagen HIV Programme (CHIP), the Medical Research Council (MRC), and the National Centre in HIV Epidemiology and Clinical Research (NCHECR).

Sponsor

The National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS