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Resistance from clinical trial?
Aug 8, 2007

I've been invited to participate in a clinical trial looking at whether or not it is beneficial to start meds soon after infection. Half of the study will receive meds for 9 months then the meds will be discontinued. All participants will be followed and compared for two years. My concern is whether or not I could be risking resistance development if I stop meds after 9 months, if I am in the med group. What do you think?

Response from Dr. Sherer

The decision as to whether or not to participate in a clinical trial is yours to make with advice and counsel from whomever you choose to ask, so I'm happy to help you consider the pros and cons....but at the end of the day, you have to make the decision. The first obvious point is that if there was a consensus on what is the best practice for someone in your circumstances with recent HIV infection, there would be no need for a clinical trial.

Your concern is correct, in so far as one clear association that has been established from the 'structured interruption' trials of ART with planned periods of treatment interruption is that drug resistance may occur as a consequence of starting and stopping ART, particularly if it is not done properly. REsistance is somewhat more likely in that setting with NNRTIs such as efavirenz (Sustiva) and neverapine(Viramune) than with the protease inhibitors.

For an assessment of the risk in this setting, i.e. this clinical trial, you should ask your doctor and the investigator who is proposing that you enter the trial. I can't provide as good an answer as they, because the risk of resistance may vary by the class of drugs and individual drugs that are involved.

Indeed, you should ask both your doctor and the study investigator what all the potential advantages of early treatment of recent HIV infections are, and what all the potential disadvantages of early treatment are. Potential early advantages include lowering the viral load set point, promoting a stronger immune response to slow disease progression, feeling better (particularly if you had significant symptoms of acute HIV), and fewer side effects from the ART. Other potential disadvantages include short and long term side effects of the drugs, potential resistance and a reduction in future treatment options, and drug interactions or overlapping toxicities with other medications that you may be taking.

To date, the data have not clearly identified a benefit that outweighs the risks, but there have been few well-controlled treatment studies. Short term therapy shows some signs of improving the immune response in some patients, but appears to show no benefit in others. The same is true for lowering the viral set point; while is may achieve this effect in some patients, the effect is not uniform, and one third return to baseline and another third have higher viral loads after therapy.

I find it interesting that your concern is for resistance in the event that you are randomized to the stop treatment after 9 months group. If, on the other hand, you were randomized to the other group, which is a 50:50 chance, you would not be dealing with this concern, and other concerns might be more apparent, as above.

The study intends to address a very important clinical question in HIV medicine, and by participating, you would help us to better understand how to, and whether to, treat acute HIV infection. There is ample high ground here. We researchers are being genuine when we praise our patients for joining the fight against the virus in this courageous manner.

If you were randomized to the stop treatment group, and you and your primary doctor were convinced that the treatment was helping you in a substantive way, you could always drop out of the study and continue on therapy. It is well accepted that if a superior treatmment alternative exists that you and your doctor believe to be better for your overall health and health care than what you are getting as part of the trial, you are entitled to it, and your doctor is responsible for helping you gain access to that course.

However, in general, I do not recommend that you enter a trial and leave it prematurely. If you choose to enter the trial, my strong recommendation is to play it straight, accept your randomization group, and follow through...but the above exception is an important one, and still stands.

As noted, take your concerns and these responses to your primary doctor first, and then to the study investigator, and get some more answers to your good questions. The right course will become apparent to you.


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