[Collection: Department of Health and Human Services on experimental PCP treatment] Item: 5 of 18
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Warner-Lambert Company.
The NIAID and Warner-Lambert studies are considered Phase III clinical
trials, usually the last research step before a manufacturer submits a new
drug application (NDA) to FDA for the drug to be licensed for clinical
use.
10. Which AIDS patients will receive trimetrexate in the clinical trials?
Because these studies are "double blinded," neither the patients nor
the investigators will know who is taking which drug. Double-blinded
studies reduce the possibility of bias in interpreting the results.
11. How can AIDS patients who have experienced adverse reactions to
standard therapy obtain trimetrexate?
Patients with PCP who experience severe or life-threatening adverse
reactions to conventional therapy (T-S and injectable pentamidine) may
qualify to receive TMTX-LCV under a Treatment IND.
On February 16, 1988, the Food and Drug Administration (FDA) announced
the approval of the application submitted by MAID to give "Treatment
IND" status to trimetrexate. This is the first drug for AIDS patients to
receive a Treatment IND (investigational new drug) status under new FDA
regulations that went into effect in June 1987.
Under this Treatment IND, MAID will make trimetrexate available to
physicians caring for patients who have experienced serious side effects
to T-S and pentamidine. A physician may contact MAID and receive
TMTX-LCV by express mail delivery if the patient meets the criteria for
participation in the FDA-approved Treatment IND protocol.
Alternatively, a patient who has experienced adverse reactions to
therapy may be eligible to receive trimetrexate in an open study
in the AIDS Clinical Trials Units.
12. What is the difference between the clinical trials and the treatment IND
for trimetrexate?
The clinical trials are randomized, comparative studies in which one group
of the patients will receive TMTX-LCV and the other will receive
standard therapy for treating PCP. These studies are designed to offer
definitive proof of the safety and effectiveness of TMTX for moderately
severe and refractory PCP.
The Treatment IND is designed only for desperately ill patients with PCP
who are intolerant to both standard therapies, and who thus have no
therapeutic options available to them. All patients in the Treatment IND
will receive TMTX-LCV.
13. How can someone participate in the Treatment IND or enroll in the
clinical trials?
Physicians interested in participating in the Treatment IND ProtocolI
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Department of Health and Human Services. [Collection: Department of Health and Human Services on experimental PCP treatment], collection, March 8, 1988; (https://texashistory.unt.edu/ark:/67531/metadc915769/m1/5/: accessed June 12, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Special Collections.