ARMY MEDICAL RESEARCH DEVELOPMENT CENTER MEMO

File: 970101_sep96_decls65_0003.txt
Page: 0003
Total Pages: 4

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






        4. Present Treatment Options:
               i
             There is no approved drug for leishmaniasls in the United States. The DoD has INDs to,
        Pentosiam for all forms of faishmaniasis, and for ketoconazole for cutaneous loishmantagis.

             a. iPOntave(ent antimony: Standard therapy for felshmantasis is Injectable antimony In the
        form of Pentostam. Present DoD policy is that all cases of lefshmantas[s be evacuated to WRAMO
        for treatment with Pentostam. However, It has no,, been possible to obtain sufficient drug from
        the sole manufacturer (Wellcome Trust, GB) to treat more than 60 patients. In addition, L..
        major Infection Is thought lo result In disease with the least morbidity and most rap!d natural
        cure time of all cutaneous laishmanlasis. Evacuation of troops to administer parenterat therapy
        for a mild skin ulcer that may seff-cure In 6 months constitutes a signlffcent detriment to US
        troop strength in the Kingdom.

             Thb committee recommended:
             -- boD IND for Pentostam be amended to Include an Associate Investigator in the Theater.
        The requirement for parenteral administration suggests a Navy MC who could administer the
        drug on a hospital ship. [ Capt O!dfield, San Diego. suggests LOdr Scott Paparallo (US Comfort)
        or Cdr Paul Garst (US Meray)l.

                 i
             --MADC (RAD 1) and USAMMDA provide written support to make a representation to
        Rhone-Poulenc, Paris, makers of pentavalont antimony In the form of G[ucgntime, to seriously
        consider-thepossib!iltyofan[NDforG]ucantlme. Olucantimeisusedinthenon-Englfsh
        speakir.a world, is apparently equivalent In therapeutic index to Pentost--.- ---30d @r. the
        English-speaking world, and has In the past been readily available in large quantities.
             -- All cases of visceral disease be given Pentostam (20 mg/ko/cfay for 30 days). and be
        evacuated to WRAMO for this purpose.
                 I
             --B@use of limited amounts of available Pento$taM, Pentostam treatment of cutaneous
        disease (20 mg/kg/day for 20 days: In Theater) be reserved for sparatic cases or for patients
        who fall other measures.

             b. Kotoconazole: Katoconazole is said to cure 70% of L. major disease and to be the treatment
        of choice In the Negev, Israel. L. trop!ca disease Is said to be resistant to ke,oconazole.
        Ketoconazole is a ilcensecl;antffungal agent that Is admlns*ered orally. Out IND covers New World
        cutaneous disease In which 600 mg once a day for 28 days was 70% curative for L B.
        ponamensis and L. rrexicana disease, but less than 40% curative for L. S. brazlilonsls disease.
        The disadvantage of ketaconazote is that there (a a transient (-I 8 hour) 213 decrease In serum
        testasterons at the doses used. The decrease In testosterone Is not noticed by clinic patients.

             The committee recommended:

             --The,IND for katocona2ois vs. loishmaniasis be amended to Include an Asso @te
        Investigator in the Theater, a now form of cutaneous leishmaniasis (O:d World disease), and an
        lncreaso In the number of patients.

             --A protocol be written In which patients with Old World cutaneous disease are randomized
        between keloconazqle and placebo.

             --An IND be prepared for the ketoconazole congeior itraconazole. ltraodnazolo appears to
        be@slightly less effective than katoconazo!e In Central American cutaneous disease, but
        itraoonazole (at 400 mg dally)has virtually no toxicity Including a lack of affect on
        testosterone.

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