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File: 970101_sep96_decls65_0004.txt
Subject: ARMY MEDICAL RESEARCH DEVELOPMENT CENTER MEMO
Unit: OTSG
Parent Organization: HSC
Box ID: BX003205
Folder Title: 4TH USAMRDC LEISHMANIASIS VARIOUS LEVELS
Document Number: 1
Folder Seq #: 11
--All patients with cutaneous disease be randomized between katoconazole and placebo
(vitamin treatment) In a study situation, or be given katoconazo!e in a treatment situation.
c,. Topical preparation containing Paromomycin: A topical preparation oontaini.,ig the
antilelshmanial agent paromomycin and an antifelshmanial disinfectant MBCL has been patented
by TEVA, Israel and Is In trial against L major in Israel. Anecdotal reports suggest that although
the MBCL slgnicantly augments the antilelshmanlal activity of the preparation In mdents, the
MBOL does not Improve clinical efficacy in man. if MBOL Is not needed, then D[VET formulation
(pammomycin plus gentamicin) will have activity equal to the MBCL formulation, and less
toxicity bemuse IVBCL Is locally irritating. In addition, paromomyoln can only be acquired from
Farmitalia, Italy (or from the USSR), and Farrnltalla is more likely to supply paromomycln to
DoO than to a competing corporation.
The committee recommended-.
--6!vET to draw up a plan to submit to the FDA for the precllnicai toxicology and clinical
evaluation of the D@'VET formulation. The plan to Include the request that clinical evaluation be
simultaneous with preclinloal toxicology (a -treatment IND-). USAMMDA to commit resources
to perform precjlnical toxicology.
..A h IND for Me TEVA formulation not be pursued at this time, but be pursued it Its
perceived disadvantages no longer pertain. These disadvantages are: Inability of TEVA to obtain
paromomycirt. lack of added efficacy by addition of MSCL to the formulation, toxicity of MBOL.
S. Summary of Recommendations:
a. C$Iagnosis: Medical assets In the Persian Gulf Region be trained by USAMRDC in the
leishmaniasis by aspiration and biopsy. If only clinical diagnosis is
available, some patients who do not In fact have felshmanlasls will be treated with potentially
toxic drugs.
b. T@atment:
Cutaneous climase. All patients with cutaneous disease be randomtnd between
getoconazole (600 mg once a clay for 28 days: in Theater) and placebo (vitamin treatment) In a
study situation, or be given katoconazoie In a treatment situation. Pentostam treatment of
cutaneous disease (20 mg/kg/cfay for 20 days: In Theater) be reserved for sporatc cases or for
patients who fail katoconazofe. Because the optimum use of Pentostarn (and ketooonazofe)
requires knowledge only available at USAMROC via i 0 years of clinical Investigation, medical
corps personnel in the Persian Gulf region should be made associate Investigators of the
USAMRDO Pentostam protocol and receive appropriate training.
Visceral disease: All cases of visceral disease be given Pentostam (20 mglkwday for 30
days), and be evacuated to WRAMC forlhls purpose.
Note: Good treatment records should be centrally reposited at USAMROC so that the
experience of Operation Desert Shield can guide future treatment of OoD forces.
6. POC: Tbl: 202-576-@3 FAX: 202-576-3114
tl@AT
Co@ BR:RMAN
Chairman, MROG Lelahmaniasis Steering Committee
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Document 4 f:/Week-36/BX003205/4TH USAMRDC LEISHMANIASIS VARIOUS LEVELS/army medical research development center memo:12249609314566
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = 4TH USAMRDC LEISHMANIASIS VARIOUS LEVELS
Folder Seq # = 11
Subject = ARMY MEDICAL RESEARCH DEVELOPMENT CENTER MEMO
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 24-DEC-1996