NIAID HIV and Emerging Infectious Diseases Program

START

Study name
Strategic Timing of Anti-Retroviral Treatment

Study number
09-I-0108

Goal of Study
The National Institutes of Health is conducting a research study to evaluate the timing of starting HIV medications. We will also try to learn more about how this strategy of starting HIV medicines early might affect other things, such as your chances of developing other illnesses or resistance to HIV medicines (where the HIV virus changes so that some medicines no longer work against it), how often you need to see a doctor, the cost of your medical care, and your general health and satisfaction with your life.

Study Regimen
If you qualify for this study, you will be randomized (assigned by chance) to one of two treatment groups. You will have an equal (1 to 1) chance of being assigned to either of the two groups. These are the groups:

If you are assigned to the Early treatment group, you will start taking HIV medicines right away after enrollment. This is the experimental (research) group.

If you are assigned to the Deferred treatment group, you will wait to start HIV medicines until your CD4+ cell count drops to below 350 cells/mm3, or until you develop AIDS or other symptoms of HIV infection. This is what is recommended by the guidelines and is the current standard of care. This is also called the “control group.”

No matter which group you are assigned to, the specific HIV medicines you take will be decided by you and your doctor. Your first HIV medicine regimen will be chosen from a list of the best regimens that doctors currently recommend for people starting treatment. If you need to change HIV medicines during the study, you and your doctor will decide what HIV medicines are best to take next.

People in the Deferred treatment group can start HIV medicines at any time on the study, if you and your doctor agree that there is a good reason to start before your CD4+ cell count drops to below 350 cells/mm3. You may develop medical problems that might be related to the HIV virus or your general health. It may be better for you to start HIV medicines for these reasons.

Eligibility Criteria

• You are age 18 or older with documented HIV infection
• You are not pregnant or trying to become pregnant; you are not breastfeeding
• Your CD4+ cell count is currently greater than 500
• You have never taken any HIV antiretroviral medications, not even one dose