I was sitting at my fuzzy beige cubicle, lost in thought, remembering my time off with Pete and the whale sharks. Sigh. What a heavenly time that was. What great sex we had. Sigh. I was so in love with him.
Pete, what is not to love.
Suddenly, Mr. Butterfly came around and popped his head over my “wall” and offered me a cappuccino. I gladly accepted it.
“Good morning!” he said cheerfully with a big fucking smile on his cute face. “Don’t forget we have a project meeting in five minutes. I’ll walk you there if you like.”
“Sure. Let’s go now. I’m sure it will be crowded.” I got up and gathered my notebook and pen.
“Penny for your thoughts.”
“Oh and they were good ones! But I am not telling you.” I sipped my cappuccino gratefully through the hole in the lid and remembered the time I was in
Everyone who was anyone at the Foundation was there. I could see the head of the organization in his finest tailor made suit and colorful Italian silk tie accompanied by his sycophants, down to the lowliest tech in his acid washed and torn jeans followed by his posse. But we were all there for the same purpose; to hear the progress of possibly the biggest discovery yet in HIV research. The lights dimmed and a spot light shined on Dr. Gutekunde, who cleared his throat.
“Ladies and gentlemen.” he began. “The news on our newest project is very positive. First of all, we have come up with a name for it. The compound will from now on be called ‘Amazonavir’.”
There was copious applause at that from the audience, after which, Dr. Gutekunde continued.
“As you are well aware, the chemical synthesis was relatively simple and the scale up was a complete success. The slides clicked in the background showing the relevant information as he talked about it. Stability studies were undertaken earlier and are ongoing. We have stability for almost a year now. We rapidly progressed to animal safety in both topical and capsule formulations and have found no significant toxicities to date.
“We are at a point of a Phase I first in man study. Protocols were reviewed internally by the Protocol Review Committee and are pending at potential clinical sites. At this point we have decided to share this research widely within our organization for comment.
“Firstly we are looking at two formulations. One is a topical that we intend to have used as a lubricant, or ‘lube’, with a condom during sex by male to male or female to male couples as a prevention of HIV infection. The second is a capsule for treatment of HIV infection.
“I will digress here for a moment. Interestingly, as a topical in animal studies, Amazonavir has been found to absorb into the mucosa providing antiviral benefit well after use. It has even been shown to enter the blood stream to a limited extent. That will make an interesting pharmacodynamic study in the future, perhaps with radiolabled Amazonavir. But I am getting way ahead of myself.
"That is why we have decided to study it as a topical lubricant for prevention of HIV infection in Phase II. It is thought that a population study where Amazonavir is used in addition to condoms in populations where the rate of infections could be studied versus non Amazonavir use would demonstrate that Amazonavir is protective against HIV infection. Obviously an Amazonavir placebo would be used in that Phase II efficacy study. There would be no risk to patients, because there are no drugs currently prescribed for this particular use.
“Briefly, in the Phase I study of the lube application, Amazonavir is to be applied in males liberally on the external skin and internal mucosa of the anus and rectum, or in females on the external skin and vaginal mucosa in healthy volunteers who will then have intercourse with a partner who is wearing a condom. Alternatively, it may be put on externally and on the condom or a syringe like applicator may be used. The dose is roughly the same as what was used in the native population, where the drug was discovered. Adverse events will be recorded before sex, during sex, after sex, and then 4 hours, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after sex. Of course, we will be checking for viral conversion as well. Patients will only use Amazonavir for one sexual act and treatment will stop. Any questions?”
I couldn’t see who asked it, but I could clearly hear the question. “Why do we have to do the Phase I trial? Why can’t we just go into the uninfected population with a Phase II trial and begin the efficacy study while watching for adverse events?”
“That is a good question. The Food & Drug Agency requires safety studies for a good reason though. We have no idea what Amazonavir or its formulation will do to people. So, we have to control its use from the start. Until we know it is safe for use in normal healthy people, we cannot study its efficacy. Shall we move on? Or are there any more questions? Gentleman in the back.”
“What will the next protocol look like?”
“The next protocol will be a multiple dose trial in healthy volunteers with the same formulation. Any more questions?
“In the second Phase I trial we will study the capsule formulation in a population that have had adverse experiences to all other alternative AIDS therapies and are otherwise generally healthy. There has been a lot of discussion around this trial. We could have used normal, healthy, HIV negative volunteers, but is it worth the risk of exposure to them to this drug when they have no potential benefit from it, when there are populations that would benefit from it? Then, if we are talking about using HIV positive or AIDS patients who are currently on other treatments, one could argue that if there are treatments with FDA approval already that they could benefit from, then they are being denied treatment with an approved drug for this study and that is not right. So, we decided to go with patients who are intolerant to all approved treatments. At the same time, this will mean that we will get many adverse events, since this is hardly a healthy population. Also, though, we will maybe see some efficacy in this study. In that way, this study is kind of an expanded access trial. FDA has shown great interest in this protocol.
“We thought about including patients who failed treatment with approved drugs, but decided not to. That would be too much of an obvious efficacy challenge in our Phase I study we thought.
“Dosing will is 100 mg/kg bid of Amazonavir per day for a period of six months. The dose was determined using our animal models. The patient will be assessed at weekly intervals for safety and efficacy as specified in the protocol and as you can see in the current slide. Blood samples will be drawn weekly in the first month and monthly thereafter. All the usual parameters will be followed including, WBC, full differential, hemoglobin, hematocrit, platelets, CD4, HIV viral load, and chemistry. Any patient who wishes to continue on Amazonavir past the six months study period may do so for free. Any questions?”
One of our lead scientists asked this “If in the 100 mg trial, Amazonavir works when all other therapies are not tolerated, why should Amazonavir not be considered as a first line of treatment since it is so well tolerated?”
“That is a really good question. The key word there is ‘works’. But let’s worry about that when we find ourselves in that fortunate circumstance, shall we?” There was some polite laughter from the audience.
There was some discussion that followed about the finer points of the study, but basically everyone was very excited about Amazonavir and what the future of the drug would bring.
After the meeting, Mr. Butterfly and I were walking back to our cubicles and I disposed of my empty cappuccino cup in the receptacle by the door. Dr. Gutekunde, who was being mobbed by people congratulating him on his talk and Amazonavir, caught my eye and asked if he could have a minute with me and Mr. Butterfly later. I said “Sure.”
A bit later, Mr. Butterfly and I were sitting with Dr. Gutekunde and discussing our next project. We both congratulated him on how the Amazonavir presentation went and how that project was going. He was humble and gracious and thanked both of us again for discovering the compound in the Amazon. I remarked on how much work had gone into the project since we brought it home. I think he blushed and said that he was adequately compensated and that the work was very important to the health of patients at large to which he had dedicated his life. I nodded and said that we all had.
“Your next project will take you to the
Dr. Volchuk Aksinya
“The real purpose of this project is diplomatic in nature. The
We thanked him and headed back to our cubicles to study the information provided. Once there, Mr. Butterfly stopped off at my cubicle to say “Oh boy, I can’t wait to see my cute little BRC again!!!!” Then he giggled and shook his ass. “My tushie misses him very much.” Then he batted his eyelashes at me seductively and asked “Are you looking forward to seeing comrade Dr. Siderov and renewing détente, Dr. Fairview?” Then he gave me such a wink that I could not possibly miss his meaning. “Or are we staying faithful to our American hero Pete?”
“That is none of your business!” said I. Trying my best to look professionally detached.
“Oh come now! Don’t pull that ‘I’m too professional to discuss it with you’ bullshit with me Susie! We’ve known each other way to long and I know way too many intimate details about your sex life for that crap to fly!” He stared me down and we stayed that way for some tense moments.
“You are just impossible!” said I, giving in. “Okay. I am staying faithful to Pete because I am in love with him. Satisfied??? Now don’t make a big deal out of it.” I sat down at my desk, resigned.
“Who me? I was just curious.” He turned to walk away and I could hear him singing. “Susie and Pete sitting in a tree, K – I – S – S – I – N…”
I stood and moved to whack him on the head with my dossier as he skittered away smiling. He was just impossible. But, I had to love him all the same. He was the life of any party; I had to give him that.Photo credits:
Pete: Brawny Stud
Dr. Pavel Siderov: GregoryNYC
Dr. Volchuk Aksinya: Completely Naked Images