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Study of Ampligen in Chronic Fatigue Syndrome

Ember

Senior Member
Messages
2,115
http://clinicaltrials.gov/show/NCT00215813
This study is currently recruiting participants.

Verified April 2013 by Hemispherx Biopharma

Sponsor:
Hemispherx Biopharma

Information provided by (Responsible Party):
Hemispherx Biopharma

The inclusion criteria have changed:
Diagnosis of Chronic Fatigue Syndrome (> 12 months) as defined by the 1988 Centers for Disease Control and Prevention CDC case definition for CFS or as defined only by the 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994; 121:953-959) (other clinical conditions which could present with similar symptoms must be excluded.)...

Locations:
United States, California
Rajan Patel, MD
Recruiting
Los Altos, California, United States, 94022
Contact: Sheila Re 650-964-6700

United States, Florida
Nova Southeastern University Chronic Fatigue Center
Recruiting
Miami, Florida, United States, 33176
Contact: Hannah Olanoff 305-595-4300 holanoff@cfsclinic.com
Principal Investigator: Nancy Klimas, MD

United States, Nevada
Dr. Daniel Peterson
Recruiting
Incline Village, Nevada, United States, 89451
Contact: Kathleen Colley 775-832-0989 kathleen@ishere.com
Principal Investigator: Daniel Peterson, MD

United States, New York
Dr. Derek Enlander
Recruiting
New York, New York, United States, 10065
Contact: Laura Melilli 212-794-2000 enlandercfs@yahoo.com
Principal Investigator: Derek Enlander, MD

United States, North Carolina
Hunter-Hopkins Center, PA
Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Wendy Fallick 704-543-9692
Principal Investigator: Charles Lapp, MD

United States, Utah
The Fatigue Consultation Clinic
Recruiting
Salt Lake City, Utah, United States, 84102
Contact: Ali Allen ali@fcclinic.com
Principal Investigator: Lucinda Bateman, MD
 

aquariusgirl

Senior Member
Messages
1,732
yeah. sorry.. just looking at it. now on the hermxph website.
i dont' know enof about the case definitions to understand the significance of any change in eligibility criteria....
 

aquariusgirl

Senior Member
Messages
1,732
yep, still self pay & with the usual suspects..lapp, klimas, peterson, bateman, enlander, and some guy in NoCal called rajan patel
 

Ember

Senior Member
Messages
2,115
Still self-pay?
Detailed Description:
An Open-Label Study of Poly I: Poly C12U (Ampligen®) in Patients with Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME). The FDA approved the study for cost recovery. Patients enrolled in the study are responsible for costs related to the therapy, e.g., drug cost, infusion cost, cost of supplies, diagnostic and other laboratory testing.
 

August59

Daughters High School Graduation
Messages
1,617
Location
Upstate SC, USA
still can't combine it w/other drugs... AVs etc

I believe Dr. Peterson was using a combination of Ampligen and AV's on Andrea Whittmore. She was not able to tolerate Ampligen at typical starting dose, so she started low and titrated up. What I don't know is if the AV's were used in conjunction with Ampligen or if they were alternating the two.

This is the best I can remember and I'm sure there were some differences from this, but it wasn't long after this that a request was made to give Andrea her privacy at that point. I never heard anymore as to how she was doing or anything.

Hopefully someone can chime in and correct and update on Andrea's condition???
 

August59

Daughters High School Graduation
Messages
1,617
Location
Upstate SC, USA
Still self-pay?

Sushi

The FDA should at least partially fund a study on a drug that is in Phase III approval, but is out of range financially for most ME/CFS patient's who are usually on disability or just cannot afford approximately $1200 or $2000 a month (I cant remember which) for treatment. That probably would not happen since it is a for profit medication.
 

*GG*

senior member
Messages
6,389
Location
Concord, NH
The FDA should at least partially fund a study on a drug that is in Phase III approval, but is out of range financially for most ME/CFS patient's who are usually on disability or just cannot afford approximately $1200 or $2000 a month (I cant remember which) for treatment. That probably would not happen since it is a for profit medication.

Are there medications NOT for profit?

GG
 

August59

Daughters High School Graduation
Messages
1,617
Location
Upstate SC, USA
I was thinking that the FDA would not help in anyway since this is will be a "For Profit" medication if I ever gets approved. It's probably not for profit now because the FDA has it classified as "Cost Recovery". Which hardly no one can afford.
 

Seven7

Seven
Messages
3,444
Location
USA
Hmmm thinking about it, it will come down to price. Anybody has a clue of how often one needs to inject at the beginning then is it every 3 months or every other month, has to be monthly???....
 

*GG*

senior member
Messages
6,389
Location
Concord, NH
I was thinking that the FDA would not help in anyway since this is will be a "For Profit" medication if I ever gets approved. It's probably not for profit now because the FDA has it classified as "Cost Recovery". Which hardly no one can afford.

Not familiar For Profit vs Cost Recovery. I know I cannot afford to be part of the study, but I do have good insurance which might cover it, if it becomes available and I think it is worth the risk!

GG
 

August59

Daughters High School Graduation
Messages
1,617
Location
Upstate SC, USA
It's about $1500 a month and unless you live very close, you have to move close to the treatment center while your receiving treatments and I believe it is for a minimum of 1 year!!

Cost recovery just means that approved test sights can administer the drug, but the patient has to pay for every aspect of the treatment while receiving it.

How do they get adequate people for testing when the cost is so high.
 

*GG*

senior member
Messages
6,389
Location
Concord, NH
How do they get adequate people for testing when the cost is so high.

Seems like a good question, perhaps there are enough people in the US with the financial assets. Unfortunatley my illness hit when I was just starting my career, so I do not have much wealth.

GG