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question about labs & clinical trail
Apr 6, 2006

Dr Wohl, I'm was infected in early Dec. of 05 and showed acute symptoms a few weeks later. First labs on 2-22-06 showed Cd4 288/24%/VL 55,000. Next labs on 3-25-06 showed some improvement CD4 366/24%/VL 23,000. A recent detuned elisa test concluded that this is a new infection. All CBC tests are normal with the exception of WBC low at 3900. Lymphocytes at 1200. No resistance except for a minor P.I. resistance mutation at A71T. I'm a healthy 39yo male, fit, non-smkr, no drugs, exercise regularly. Is it normal to have such a low CD4 count this early in the game? Is that WBC count cause for concern? I was hoping for a least a couple of years before needing treatment. Also, I'm considering joining a clinical trial of Truvada/Kaletra that will test the efficacy of early treatment. Meds are given for 36 weeks, then stopped. What is your opinion of early treatment with this combo? Given that the SMART study was stopped by the Feds. earlier this year, do you think those results bode poorly for this study? I have read that there is growing opinion that once you start meds, you should not stop. Also, what is your opinion of the newly formulated Kaletra in terms of G.I. side effects. Do you have a preference to starting treatment with a NRTI/PI compared to a NRTI/NNRTI? Thanks for all the hard work you docs are doing on this site!

Response from Dr. Wohl

These are good questions.

Reagrding the clinical trial, I think this is an excellent study. The aim is to determine whether a relatively short treatment course soon after HIV infection (but after seroconversion) can reduce the viral set point, the level of virus in the blood off of HIV meds. Stopping therapy in this study should not be confused with what was done in SMART and like studies where therapy was discontinued among patients who had a prior indication for treatment. Applying HIV therapy so soon after HIV seroconversion is not standard and remains investigational.

.

Your CD4 cell count is not atypical for early infection and will likely increase with or without HIV treatment over the next few months.

I try to tailor HIV therapy to the needs and preferences of the individual patient. For some an NNRTI-based regimen is a good fit and for others a PI is the way to go. I think the new Kaletra is more convenient (less pills, can be kept out at room temp) and may have less side effects as the fillers used in the softgels have been removed. So far, so good among the patients I have switched to the new formulation.

Do note that in the study you are considering you may be assigned to the group that does not take any HIV therapy at all.

Thanks

DW



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