My Adventures with Crixivan
or Toxic Side Effects, Anyone?

I AM WRITING this article because of my recent hospitalization resulting from the popular protease inhibitor, Crixivan. The "side-effect" I suffered from this drug was complete blockage of my left kidney, almost causing kidney failure. Before I detail my saga, there are a few things I need to tell you about myself.

My HIV History

I was infected with HIV in late 1987. I tested positive in 1990. I joined a women's support group one week after my diagnosis. All of the women in this group, except one, were taking AZT. I didn't want to know from drugs, treatments, side-effects, opportunistic infections, or doctors, so for the first year I only sought alternative therapies. I had my first t-cell test in 1991, it was 130. Something deep inside of me said "Don't take AZT, it will kill you before AIDS." Much of the information which came my way over public radio, though publications and books like Michael Callen's inspiring "Surviving AIDS" supported my decision.

In spite of my low t-cell count, I felt great. I continued to work and live a fairly normal life. The only western medicine I decided made sense was aerosolized pentamidine to prevent PCP. (After a year, I did start to learn the lingo and also see an HIV specialist.) My t-cells would rise and fall randomly. They went up to just above 200 and stayed in this range for four years, until 1995. I joined a medical trial where they did one of the first viral load tests. I was the only one in the trial not on any western medications and my viral load was the lowest of everyone, 10,000. My treatment consisted of mega-vitamins, drinking lots of vegetable and wheat grass juice daily, acupuncture, massage, yoga, meditation, sincere spiritual searching, and tons of love from a great man.

In the summer of 1995 my t-cells plunged to 67. Then I got cryptospor-idium over Labor Day Weekend. I had recently been on vacation in the mid-west where I went tubing in a river and swimming in a lake. Both of these places are potential homes for "crypto.'' Luckily, I cleared the "crypto" in a week. However, my t-cell count was now down to 46. My viral load was 600,000. And I had no energy whatsoever. I knew I had to seriously consider taking some strong medications.

The main reasons I waited so long, was I knew that protease inhibitors were on the horizon and the buzz was good. I also thought the double and triple combination therapies were the first to make sense to me. I wanted to wait and hit HIV with the "one, two, knock out punch" triple combination promised. But with only 46 t-cells and being wiped out from "crypto", I felt I couldn't wait any longer.

Aware that antivirals are chemotherapy, I wanted to take the ones with the least side effects. My supportive and very patient doctor and I discussed my new therapies and decided that 3TC and D4T would be a good combination for me. It was. My t-cells went up to 130 and my viral load went down to 40,000.

The Cocktail

I began taking Crixivan as soon as it became available. My decision to take Crixivan over Norvir was simple for me; Crixivan had less side effects. Norvir's biggest problems are gastro-intestinal and I've had those problems all of my life, as did my mother and as does my daughter. I never considered Saquinivir as the results didn't seem good enough.

It seemed like the biggest danger of Crixivan was the possible side-effect of kidney stones. I thought "No problem, I drink tons of water, day and night, have been for years." You'll never find me without a bottle of water in my car or in my purse or in my hand. I knew the routine of taking the drug every eight hours was going to be tough, but I made up my mind. I became a very compliant pill-taker. No drug holidays, ever. (When I was taking only 3TC and D4T I would often take Sundays "off"). But I did not want protease resistance, so I always took my Crixivan. In the seven months, I think I might have missed at most three doses.

The reason I detailed my history is so you can understand my mind-set. I have been the one making the decisions about my health care. I like to have as much information as possible. I know HIV is a strong and dangerous virus, I also know the drugs used to combat it are equally strong and dangerous. They have to be, right? I also know that the quality of my life matters far more than the quantity. If I'm going to be alive, I want to be able to enjoy myself. Here comes the saga...

Crixivan Sludge

I started Crixivan in July of 1996. I felt so good that I even went back to work. Then, after almost five months on the drug, I started becoming fatigued. It snuck up on me gradually. At first I needed 9 hours of sleep, then 10, then 11, then 12. And even after 12 hours, I was dragging myself out of bed, and never had any energy. My doctor said Crixivan could cause fatigue, but he ran a bunch of tests to see if I had something else going on. The urine test showed a lot of bacteria, so I took a round of antibiotics for what seemed to be a urinary tract infection.

While taking Crixivan, my viral load was always undetectable, but my t-cell count never went up, in fact it dropped a bit from 133 to 121. I started to get a buzz after my second dose of the day. Sometimes I'd feel so light-headed I'd have to lay down until I could eat. I was also experiencing some intermittent pains in my low right back. I do have two ruptured discs, so back problems are familiar to me. But yet, I wondered if it could be my kidney. Everyone thought the pain was too low to be my kidney. (I have since found out where my kidneys are, apparently they are lower than most peoples.) The pain came and went. So when it went, I forgot about it. Until February, 1997.

I live by the Santa Monica courthouse, so on February 4th when they were going to announce the O.J. verdict, my boyfriend and I, who have been following these trials like addicts, decided to go join the media madness. After standing for a few hours sandwiched between a surly sound-man and a fat woman trying to crawl between our legs for a better look, my low back started to hurt. Big surprise.

That night, I had a strong, quick dizzy spell. Suddenly, I got very tired and went to bed. I woke up at 2:00 a.m. with what I thought was very bad gas. I couldn't sleep so I got up and watched a movie. The pain never went away.

I slept very little that night. In the morning I was definitely sick. I vomited several times. My back hurt, although not on the right side as before, but on the left, and the pain was a constant ache which seemed to radiate out. My intestines were cramping and my stomach hurt. I thought I had the flu. But in the afternoon there was blood in my urine, so my boyfriend took me to the hospital. Fortunately, my doctor was working in the ER, so I went right in.

By this time, I was now shaking like the proverbial leaf. My whole body would just tremble, uncontrollably. The vomiting and pain were getting worse. My doctor ran some tests, and ruled out kidney stones and thought I had a kidney infection. He checked me into the hospital for the night.

No Stones

The next day a different HIV specialist came in, and decided I most likely had kidney stones caused by the Crixivan. Meanwhile, all I could do was writhe in pain. I couldn't sleep, couldn't eat, and could feel a poison running through my body that just wasn't leaving. They had me on an IV and were pumping me full of fluids. But every time I would go to the bathroom, I would shake all over for several minutes. After one full day in the hospital I had an ultrasound to check for the kidney stones. None there.

The next day the doctor said they didn't know what was wrong, but I was going into renal (kidney) failure. Still in pain, still sleepless, I was very scared. They ordered a CT scan to try to see what was happening with my kidneys. The scan showed that my left kidney was completely blocked. I was now out of the realm of the HIV specialists and into the hands of a urologist.

Dr. Saint

That day, I went into an operating room to have a "procedure." The urologist, or as I like to refer to him "the most wonderful, most important person in the world, probably some kind of Saint," put a shunt into my kidney to open it up. Essentially, he did a kidney Roto-Rooter job. I also had a catheter into my bladder. Immediately, I felt better.

The next day when Dr. Saint came to talk to me, he told me that he'd looked into my kidney with a microscopic camera and saw something he'd never seen before. My kidney was filled with a heavy sludge, and floating throughout were thousands and thousands of Crixivan crystals. This is what caused the blockage.

Water, Women & Dosages

Since my hospitalization, I have heard that kidney sludge is being seen in other people who are taking Crixivan. They are being told that the way to prevent this is to drink more water. I know that I drank more than the recommended amount. But, I drank this much before I ever took Crixivan. Perhaps I should have doubled my water intake when I started taking it. But, really, how much water can a person consume? People on Crixivan are also being told to be certain that their doctors are doing regular urinalysis.

But could there be another compound problem? My best guess is dosage. The dosages of many drugs are based on weight. This is done with almost all over-the-counter drugs as well as children's medicines. Why isn't it done with these incredibly strong, toxic drugs we are all taking? I know they like us to take the maximum dose possible, but should a 115 pound woman really take the same as a 180 pound man?

Also, because of the room needed by our reproductive systems, women have smaller organs. Our kidneys and livers are smaller than men's. And what effect do the drugs have on our hormones, and vice versa? The day after I had the shunt put in my kidney, my period started, ten days early. It lasted for two weeks. My hormones were definitely contributing their share to this whole trauma. I had to take Provera to stop my menstruation. Maybe we can't, due not only to weight, but also to gender, tolerate these dosages.

How Many Women

I don't know how many women were in the clinical trials, but it's a safe bet to say "not many." I don't know how many finished, nor how compliant they were. I do know that if I had been told that kidney failure was a possible side-effect of Crixivan that I would never have taken that drug.

We know that there are not enough women in the clinical trials. Not in any clinical trials. But there are some. And the drug companies have the data. We need and we have the right to have that data analyzed by gender. Our lives depend on it.

 

TWO PROTEASE INHIBITORS APPROVED FOR KIDS! Pharmaceutical companies have been slow to conduct clinical trials in children. Finally Viracept & Norvir have been cleared for pediatric AIDS cases.