About this trial
This trial is providing people who have limited treatment options open to them access to maraviroc until it offically becomes available. In the process, the trial will collect more safety data on the drug.
Background information
Maraviroc is from the new class of antiretrovirals called CCR5 inhibitors or antagonists.
CCR5 inhibitors block the CCR5 co-receptor, one of two chemical doorways that HIV uses to enter and infect the cell (the other is CXCR4). CCR5 inhibitors work specifically against CCR5-tropic HIV, but some people have a CXCR4-tropic HIV (meaning their strain of HIV uses the other co-receptor) or dual/mixed-tropic virus (meaning their virus uses both).
Usually, CCR5-tropic HIV predominates during early infection while CXCR4-tropic HIV typically appears during later stages and is associated with more advanced disease. That's why before being treated with a CCR5 inhibitor you need to have a tropism test to determine whether you have the right strain of virus this drug class will affect.
Some experts have expressed concern that using a CCR5 antagonist might suppress CCR5-tropic virus and thereby encourage the emergence of CXCR4-tropic strains. But studies have shown that after withdrawal of maraviroc, CCR5-tropic virus re-emerges as the dominant population, with reversion taking about 16 weeks.
| Official title: | A Multi-Center, Open Label, Expanded Access Trial Of Maraviroc |
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| What is this trial studying? | New drug |
| How many participants will this trial enrol? | 1300 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. |
| Who can enrol in this trial? | You may be eligible to participate in this trial if you meet the following criteria:
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| Links to further information: | |
| Can I access this treatment other than by enrolling in this trial? | Yes, via the Celsentri Supply Program. Your doctor can contact the program administrators on 1800 981 112 for further information |
| Keywords: | CCR5, entry inhibitors, maraviroc, multiple resistance |
If you are interested in enrolling in this trial
Before making the decision to participate in any clinical trial, NAPWA recommends that you discuss the potential benefits and risks of participation with your treating doctor. Your doctor can also provide advice about your eligibility to participate in the trial.
- You can print this page to take it with you to the doctor – just use your browser's 'print' function.
- Before making the decision to participate in any clinical research, read our background information.
- Email NAPWA if you have any questions or comments about this trial
- Call the Treataware info line if you need further advice
If you've ever participated in a clinical trial, or tried to make sense of scientific research reports, you may have found some of the specialised language confusing to say the least. This Backgrounder (from the Nov-Dec 2002 edition of Positive Living) looks at the vocabulary of clinical trials.