NAPWA

About this trial

This international, randomisedA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant studyA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. aims to determine the most appropriate time to start treatment: when T-cell counts are above 500 or, as is the current recommendation, when they drop to 350.

All participants will be treatment naive with counts above 500 cell/mm3 and will be randomised to either receive immediate treatment or wait until their counts drop to 350 (or they develop an AIDS-defining condition).

Background information

Currently, starting antiretroviralA medication or other substance which is active against retroviruses such as HIV. treatment is usually only recommended when your T-cell count falls to around 350 cells/mm3. (Normal range is 500-1200).

With certain exceptions, treating earler than this is considered unnecessary for a number of reasons. It prolongs your risk of developing longterm complications from the drugs. It's more likely you'll get tired of taking pills, miss doses and develop resistanceHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant.. It's more expensive.

However, there's some data which suggests that treating earlier might in fact be a good idea.  Recent studies compared treaters with non-treaters at identical cell counts and found that the risk of developing an AIDS-defining condition was higher for the non-treaters even when their counts were well above 500 cells/mm3.

T-cell counts have always been an important clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. marker. Certainly, higher counts reduce the risk of developing serious AIDS-related conditions (like PCP) and non-AIDS-related conditions (such as cardiovascular disease).  But we're starting to question whether there's more going on than can be assessed simply by counting T-cells.