Dear Doc,

I was diagnosed in Jan 2001 with HIV. My viral load was 53000 and my T cells 609. My doc wanted a second set of tests done at from a different lab, in March. the VL came back at 59000 and the T cells at 350. He thinks that's an unlikely sudden drop in the T cells, but thinks i should consider meds. He added that there was no real urgency, but to think about it.

I've been offered a chance to enter a study to see if the addition of Remune to Viracept and Combivir is effective. I've not been on any meds and would like your opinion on the study vs 'regular meds'.

My whole HIV experience has been very abstract, not having any symptoms and the imformed consent letter to enter the study has been very graphic in detailing possible side effects. So, it's now becoming very real and a bit scary.

Thanks for any insight you can offer.

s

Dear S

Let me answer your question by asking two questions. Is it time for you to start taking medication? If you were to start, would the study give you good treatment, whatever arm you ended up on?

We spend a lot of time debating about numbers on when to start, but the truth is that there are no firm answers. It still largely comes down to: "when you are ready" If you look at the PHS guidelines, your viral load of more than 50,000 would suggest you should consider starting. Your T cell count of 609 would generally speak to waiting, but the one of 350 would suggest it is about time. It is not uncommon to see occasional CD4 counts that do not jive with each other, and you probably need to do two things to sort this out. One is to look at the CD4 percent. If it is near or below 25%, that suggests that the lower number is the more accurate one. You probably could benefit from one more CD4 count before you decide.

If you do decide to start treatment, it sounds like a pretty good trial to at least consider. Combivir and nelfinavir is a very reasonable first line therapy. It has the advantage of preserving many future options and having fairly low rates of serious side effects. Nelfinavir (viracept) does cause at least some loose stools in many people and significant diarrhea in a few. Most of the time this can be easily controlled with oat bran and/or immodium. However, there are some people who continue to have problems. The idea of using remmune with the first HAART regimen is an attractive one. The hope is that it would be a totally safe way to boost your immune response to HIV. Preliminary results have been mixed, but limited by trial design. A small study, similar to the design of the one you are looking at showed marked improvement in laboratory markers. A large but somewhat controversial study failed to show a benefit in terms of disease progression, but there were few virologic or immunologic measures and the treatments used and the patiens in the study were an incredibly mixed bag.

Studies offer some pluses and minuses. You get free drug, frequent news on your lab results, usually work closely with nice people, and may get a new drug that helps. You also have to make frequent trips in, get poked once a month, and accept the randomization choice. There is the intangible of being part of something that is new and may help others. It is an individual decision

As your doctor said, even if you want to start therapy, there is no rush. Think it over, talk with people, and make sure you feel ready.

Good luck ATP