Chlofazamine Clinical Trial Experience and Watch & Wait

Thanks for your post and please keep us updated on your progress! We can learn much from each other.

I gave the wrong date for the CT comparisons. The oldest was in 2017, and the three Dr. Winthrop was comparing, were done in October 2022, May 2023, and January 2024.

Good morning, I have been asked to participate in this trial at USF. My concerns are the skin discoloration, eye issues, macular degeneration, which I have had for over 10 years. I have had 3 sputum cultures that were positive. We have been watching and waiting for 2.5 years as I am asymptomatic. I am 76 years old and would like input on anyone else who has experience with the Clofazamine trial. Thank you for your input. I do Albuterol and 7% saline daily which I started a year ago. Only coughing up sputum when I do my nebulizing, and not great amounts at all.
Your information is greatly appreciated.

I was prepared for some tanning (my doctor said some of his patients enjoyed that side effect!), dry skin and hair, and possible digestive upsets. Since I don't tolerate nausea well (does anyone?) I took the pills at bedtime with a little ice-cream (or sometimes a bit of cheese). Dr. Winthrop said to take them the same time every day with a little bit of fat. I took a probiotic in the morning. The first few weeks I'd sometimes get a wave of nausea in the mornings, but it would disappear as soon as I noticed it. I also had mild diarrhea a couple times, which is not that unusual for me. But no tanning, and my skin and hair didn't get any drier than normal for me. I'm 77. So as I said before the prolonged QT was really my only side-effect. If you decide to participate in the trial, I hope it goes as well for you.

I'm on Clofazimine along with the other 3 antibiotics for MAC. I have a slightly tan completion naturally and the Clofazimine just added a little more color as if I had a suntan.

Thank you. I want to do this trial but not sure I am brave enough to try. Any information you can offer would be great. Side effects, etc.
After reading all the information in the trial material it sounds so scary!!! Can't make a decision.

I have no experience with this drug except for my reading about it. Rifampin which it would replace is a drug that is not necessary for MAC treatment as much anymore. My question to you would be why not try Arikayce? It does work against MAC. Also, if you have no symptoms why are you considering this medication ? Irene5

That's is what I am thinking, no symptoms, leave well enough alone. My doctor at USF thinks I should do it but there is no pressure from him. My doctor at Mayo said he would not be opposed to it. I trust them both explicitly, but just think it's too much at this time of my life.
Thank you for your input.

In my case, my pulmonologist was recommending immediate treatment and the ID doctor was also saying I'd eventually need treatment. To me it was an opportunity to either be "treating" (if I got the drug) or being very carefully "watched" as I waited another 6 months. None of the potential side effects were that frightening to me, so I was happy to participate, both for myself and as an opportunity to contribute to the field of knowledge. You said you are concerned about macular degeneration. I have not seen anything about a connection, but if it makes you uncomfortable, then "leaving well enough alone" may be the best choice for you. All best, whatever you decide.

The trial begins with 4 months of 200 mg a day for 4 months. Then it drops to 100 mg a day for 2 months.

My skin did darken, and it did become extremely dry. The nurse recommended Gold Bond cream. I never had nausea and always took the meds with the evening meal. I was told to take it with food, and I think that taking it with a full meal hindered some absorption. I think the small amount of fat is a better idea.

I had some loose stools occasionally but no diarrhea. No pains or nausea. I felt well and found it easier to gain weight on the 200 mg. Clofazimine. A couple of weeks into the 100 mg, I began to feel tired. My doctor pulled me out of the trial after 6 months because my numbers started climbing.

It has a long half life. I started the Azithromycin and Ethambutol 3x weekly immediately after stopping Clofazimine, and I dropped to just a few colonies in a few weeks. My doctor had to wait until six months before adding the nebulized liposomal Arikayce. They will soon allow Arikayce to be started right away with the other drugs. Since the Arikayce is nebulized, and I only use it 3 times a week, I don’t have side effects that would occur with daily use of if it was in pill form and swallowed. I have been smear and culture negative for 3 months now.

I think the Rifampin is the nasty med that causes so many issues. Since they now have Arikayce, you can be treated without Rifampin. I always think about the people who stopped their meds because of Rifampin side effects

Clofazimine is probably better for people with mild disease. Probably more effective as a single drug for those people. It is the best when combined with 2 other drugs because it facilitates their entry into the cell wall. When I was first diagnosed, I had a +2 smear and a +3 culture and had symptoms. The Clofazimine alone will have better results if you are not yet symptomatic.

I think they are looking for a maintenance drug that is more tolerable, and Clofazimine is. It took about 5 -6 months for my skin discoloration to disappear. I would say that, for me, the extreme dryness was the only bothersome side effect. This is one of the more tolerable drugs.

I would not be afraid of the drugs they have now. This bug damages your lungs and worsens bronchiectasis, which then leads to more risk for bronchiectasis and greater likelihood of reinfection. By treating it early, you shorten time to culture conversion and lessen damage. That is just my opinion from what I have learned. If you have an excellent team that is closely monitoring you, they will know when it is time to start meds.