Ampligen Treatment Study (AMP 511) starting in San Francisco Bay Area

We are a group of ME/CFS patients coordinating contact information for those interested in receiving Ampligen in the San Francisco Bay Area in California.

Sites administering the drug under the FDA approved open label AMP 511 study protocol have dwindled to Dr. Peterson in Incline Village, NV and Dr. Lapp in Charlotte, NC. An expansion of Ampligen sites has begun, including reactivation of Dr. Bateman’s site in Salt Lake City, UT.

A local physician that has experience administering the drug has contacted Dr. David Strayer at Hemispherx Biopharma, manufacturer of Ampligen, and has received the OK to start an open label Ampligen treatment protocol in the lower Peninsula Bay Area. The doctor needs a minimum of two participants for the study to be economically viable.

* The physician is a fee-for-service provider. Patients pay the doctor directly for services at the time services are rendered, and submit his/her own claims to insurance.

* Before being enrolled in the treatment protocol, patients will be tested for biomarkers to determine the likely response to Ampligen.

* After the doctor determines the patient is appropriate for the study, they must remit a $1,000 deposit to the physician, after which the paperwork will be started for the study. The paperwork takes approximately two months to complete and approve before Ampligen is administered.

* Patients withdrawing during the paperwork period will forfeit their $1,000. Patients who continue will have the deposit applied to their cost of Ampligen administration.

* The total cost of the administration of Ampligen to each participant is approximately $2,500/month.

* The physician estimates for many patients it’ll take 18 months to achieve the full therapeutic and stabilization effects of Ampligen. Participants should plan for that timeframe.

* Two Bay Area ME/CFS patients have already started the process to qualify to receive Ampligen under the open label treatment protocol.

Ampligen has a controversial history, including refusal of the FDA to approve retail marketing of the drug due to efficacy questions. Also, some patients state they’ve become worse on the drug. However, Ampligen has been clearly beneficial for a subset of ME/CFS patients. Some of the clinical factors that may identify these patients:

* Acute Viral Onset
* 2-5A Synthetase/RNase L Up Regulation
* Depressed Natural Killer Cell Cytotoxicity
* Persistent Herpes Virus Infections (EBV, HHV-6, CMV, etc)

Ampligen often initially causes dose dependent flu-like symptoms that can be significant. This has contributed to patient reports of Ampligen’s adverse effects. These are not the only health risks from Ampligen. Titrating the Ampligen dose may help minimize side effects. Ampligen is administered intravenously twice per week, so people with fragile veins may have difficulty with infusions. IV ports are sometimes installed.

Ampligen is administered under an experimental drug treatment protocol, and may be discontinued at any time without penalty by the participant, the FDA, the manufacturer, or the study principal investigator (usually the administering doctor). Before a person enrolls in the drug treatment protocol, the risks will be explained, and participants must sign a consent form. Persons that improve and consequently stop Ampligen for an extended period may eventually relapse after a unpredictable length of time. Some patients restart Ampligen when they start to relapse.

While many ME/CFS patients have an interest in Ampligen, the AMP 511 Cost-Recovery treatment protocol requirements are expensive:

*Ampligen is administered from 200mg or 400mg vials. The cost of the Ampligen alone, at the usual therapeutic dose of 400mg twice per week, is $1,200 per month, and is rarely covered by medical insurance. Some patients, however, may require a lesser dose.

*Infusion costs, administrative costs, and testing are extra, are generally not covered by insurance, and will cost approximately $1,300 a month.

This notice is for informational purposes, and is not intended to be an offer or guarantee of any sort.

Persons interested in Ampligen treatment in the San Francisco Bay Area, and have the resources to pay for the costs involved, please

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2 Responses to Ampligen Treatment Study (AMP 511) starting in San Francisco Bay Area

  1. James York says:

    Just wanted to add that Dr. Klimas in Miami is also part of the upcoming Ampligen Trial Sites. Of course, Florida is far removed from the West coast, but then again, so is North Carolina. Just in case anyone has other influencing factors such as Family or Friends in the Miami area, thought people should know that there is one more site to choose from.

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