The SMART Study

This trial has been cancelled. Clinical trials may be cancelled prior to commencement, or during the course of the trial, for a number of reasons – these may be summarised below. You cannot enrol in this trial.

About this trial

The purpose of this study was to compare two ways of using antretrovirals: (1) continuously treating with them or (2) only treating when T-cells dropped to 250 and then stopping again when they rose to 350.

The hope was that periodic treatment would prove to be just as effective as continuous treatment and would protect people from any long-term toxicities.

SMART was a large and important trial designed to last for a number of years but was terminated early because  those on the "treatment interruption" armAny of the treatment groups in a randomised trial. Most randomised trials have two "arms," but some have three "arms," or even more. were found to be at higher risk of disease progression.

For further reading, please follow the links listed here

Official title:

A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

What is this trial studying?

tx_strategy

Start date:

January 2002 (This may be the proposed or expected start date for trials which have not yet started.)

How many participants will this trial enrol?

6000 (The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic.)

How long is this trial planned to go for?

Participants in this trial will be asked to follow the treatment strategy for 3 years. Following the conclusion of the trial, participants will be followed up for a further 4 years.

Links to further information:

• http://clinicaltrials.gov/ct2/show/NCT00027352?term=SMART&cond=hiv&rank=1&show_locs=Y#locn

Related trials:

• (http://napwa.org.au/node/)

Who can enrol in this trial?

You may be eligible to participate in this trial if you meet the following criteria:

• At least 18 years old
• CD4 count at least 350 cells/mm³

This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.

Results:

The trial was halted on 11/01/06 with this press release: http://www3.niaid.nih.gov/news/newsreleases/2006/smart06.htm

Disclaimer

While NAPWA has taken every care to compile the information on this page and to keep it up-to-date, we cannot guarantee its correctness and completeness.

Before making the decision to participate in any clinical research, visit the NAPWA website for background information on participating in clinical research.

Contact NAPWA if you have any questions or comments about this trial.