Question
Should I participate in a clinical trial for treatment in early infection?
4 December 2008. Related: All topics, Clinical trials.
Hi guys.
Thanks for all your info on here. I have a fairly complex question with regards to a trial suggested by my doctor.
I have been infected with HIV fairly recently (just over 3 months) and am still in primary infection stage.
My doctor has suggested a short-period of combination therapy (3 x Darunavir, 1 x Ritonavir, 1 x Truvada daily) for 12 months only. My viral load is 50,000 and my CD4 is just above 500. He has mentioned that he would definitely not recommend continuing treatment past 12 months.
The goal of the trial is to see whether the medication will assist in strengthening my immune system before my HIV infection causes permanent damage to it.
I’ve been told that the ultimate goal would be reduced viral load and boosted natural immune response to HIV, resulting in a longer period of time before I am dependent on ARVs.
My specific question relates to whether short-term ARV use at the very start of the infection has been effective in the past?
Is there any info on this at all, or have there been any other similar studies in the past?
Am I likely to develop a resistance when I stop the meds, and will this limit my treatment options in the future when I am reliant upon ARVs?
Also, side effects with the meds above have ‘common’ side effects of lypodystrophy, ‘bone problems’ and ‘creatine kinase’… how common are these? And more importantly, what the hell are they?!
Sorry for all the questions, but I am really confused about what to do here (although I am leaning towards participating in the trial) but just want as much info as possible and a second opinion before I make a decision. Really have found it hard finding this stuff out on the net.
Many, many, many thanks
Answer
Thank you for the nice words.
Years ago the ‘hit early, hit hard’ was the mantra that everybody subscribed to. Nowadays, it is recommended that treatment starts when your CD4 count is about 350.
There are several things that you need to consider. Firstly, studies of this kind have already been done and they failed to show any clinical benefit from starting treatment during the seroconversion.
The most recent report of a trial in early infection was published in last months AIDS journal. The abstract is here but please let me know if you would like a copy of the full study by email.
An earlier publication is here and information on an ongoing trial is here. If you participate in a study you will receive a closer monitoring and will contribute to science. Some of the research into early immune responses is very interesting and is still important.
At the same time, this is a treatment that you do not need for your immediate health and you will start something that will put you in a situation where you need to be on medications for a year with all the pluses and minuses.
Some people feel better on treatment because their HIV in controlled. It is also likely to reduce the risk of transmitting HIV because you will be less infectious. But this is a lot to think about and you can take time before deciding what you want to do.
There is very detailed information about the side effects here. Lypodystrophy (changes in body fat) is unlikely with those drugs over a year, as are bone problems.
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