NAPWA

About this trial

This is an ongoing Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. trial of an HIV antiretroviralA medication or other substance which is active against retroviruses such as HIV. from a new class of drugs, known as 'entry inhibitors'. Entry inhibitors work by trying to prevent HIV from attaching to or being able to enter and infect cells.

The drug in this trial, maraviroc, is designed to prevent HIV from attaching to specific 'receptors' on the surface of human immune cells. If it can't attach to the cell, it can't infect it (see Background Info for more discussion). The particular cell 'marker' which HIV uses to attach to a cell is called CCR5. This drug aims to prevent HIV from being able to use this to attach to and then get into cells.

This is a 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 study, and compares the experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. treatment (for treatment naïve), maraviroc, against a drug commonly used to treat HIV, efavirenz. All people on the study receive either maraviroc OR efavirenz, with all people receiving AZT and 3TC as well, to complete their combination. The study is comparing the maraviroc with the efavirenz, looking at how effective each drug is against HIV, and comparing the two for safety and side effects.

Background information

For HIV to enter and infect your body's CD4 cells (T-cells), it first has to attach itself to them. HIV does this by using a marker on the surface of your CD4 cells, called a chemokine receptor. A chemokine receptor is basically a kind of protein or chemical messenger. HIV attaches itself to this chemokine receptor and from there, is able to get into the CD4 cells and take them over.

There are two main chemokine receptors to which HIV usually attaches itself. They are known as CCR5 and CXCR4. This study is looking at whether by using a new drug designed to prevent HIV from attaching itself to the CCR5 receptor of CD4 cells you can control HIV by stopping it from being able to infect new cells.