New Class Of HIV Fighting Drugs The Protease; One Woman's Experience

I am twenty-two weeks into the Merck MK - 639 protease inhibitor clinical trial. This trial was appealing to me because it was in phase III. It was also open label, meaning I would know from the beginning which drug(s) I'd be receiving, as opposed to taking substances unknown to me. This trial has three arms: protease inhibitor alone vs. pro- tease inhibitor plus AZT vs. protease inhibitor with AZT and ddI. The trial was randomized, in other words, a computer assigned participants to one of the three arms. I had strong feelings against AZT and couldn't imagine taking a combination of 3 medications.

I called all of my friends and my family to ask them to wish me luck, cross their fingers, to do anything short of a Novena to ensure I'd get the protease monotherapy arm. I literally jumped for joy when I was told that I would receive protease inhibitor alone.

I had heard of the wonders of protease inhibitors while attending the International Conference on AIDS in Yokohama. I understood that the Merck Protease inhibitor was the best; it worked better with no side effects, etc. I even considered enrolling my two year old daughter in an NIH protease trial but decided against it because it was only in Phase 1.

My T-cells were 250 when I started. They increased to 290 within a month. I was very excited! I felt energetic! Three months into the trial I developed acute sinusitis and was put on Biaxin. Yeachh! I felt green, looked yellow, and was vomiting bile first thing in the morning, every morning. After thirteen days on antibiotics the picture improved slightly.

Then the bad news. In January my T-cells dropped to 190. Yikes! Statistically, other participants were celebrating the doubling of their T-cells by this point. I was depressed and anxious because the mention of Bactrim for PCP prophylaxis was suggested. I was not ready to hear this. My wonder drug was letting me down. So, I stopped taking the protease for 2 weeks. I repaired my fried liver by taking milk thistle and thioctic lipid acid, both recommended to me by DAAIR. When I went back to my trial site with my unused drug, I was informed that I could do "low dose," which meant taking one capsule four times a day versus three capsules four times a day. Oh joy!

My blood work was done meticulously. We increased my dosage to 2 capsules 4 times a day. I've tried to increase back to the original dose but found that I couldn't tolerate it. The good news is that I feel like I've struck a good balance. My T-cells have gone up to 390 and my liver functions are within normal limits. Now, I have to decide what to combine with my protease inhibitor. Cats claw? *SPV-30? AZT!? The combinations are endless! Not all are allowed on the study so I'll have to check it out, then go with what feels right.

Reprinted from AIDS Treatment Data Network 212-260-8868 Original Title: "For Investigational Use Only"

*SPV - 30 is an herbal compound taken from the Boxwood tree. Researchers in France are doing Phase II, and Phase III studies. There are some informal studies in the U.S. Call David Stokes for more information: 617-424-9195.