OPERATION DESERT SHIELD AND LEISHMANASIS 19 DEC 90

File: 102496_sep96_decls7_0003.txt
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Total Pages: 4

Subject: OPERATION DESERT SHIELD AND LEISHMANASIS 19 DEC 90              

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003202

Folder Title: DESERT SHIELD MEDICAL ISSUES REVIEW AND AD HOC WORKING GROUP                                    

Document Number:          2

Folder SEQ  #:         31






    4, Present Treatment Options;

         There is no approved drug for telshmaniasts in the United States. The OaD has iNDs for
    Pentostam for all forms of lsishmaniasis, and for ketoconazole for cutaneous lelshmaniasis.
         a.!Pantavelent antimony: Standard therapy for faishmantasis is lnjectlble antimony in the
    form of.Pentostam. Present DoD policy is that all cases of lelshmanlasis be evacuated to WRAMC
    for treatment with Pento3tam. However, it has not 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 to result In disease with the least morbidity and most rapid natural
    cure time of all cutaneous laishmaniasis. Evacuation of troops to administer parenterat therapy
    for a mild skin ulcer that may seff-cure in 6 months constitutes a significant detriment to US
    troop strength in the Kingdom.

         The committee recommended:

               IND for Pentostam be amended to Include an Associate Investigator in the Theater.
    The requirement for parenterat administration suggests a Navy MC who could administer the
    drug on a hospital ship. I Capt Oldfleld, San Diego, suggests LCdr Scott Paparello (US Comfort)
    or Cdr Paul Garst (US Mercy)].
         --MKOC (RAD 1) and USAMMOA provide written support to make a representation to
    Rhone-Poulenc, Paris, makers of pentavalent antimony In the form of Glucantime, to seriously
    consider the possibility of an IND for Glucantime. Glucantime is used In the non-English
    speakina world, is apparently equivalent In therapeutic index to Pentostam used In the
    English-speaking world, and has in the past been readily available in large quantities.
         -- AN cases of visceral disease be given Pentosism (20 mgikg/day for 30 days), and be
    evacuated to WRAMO for this purpose.
            I
         --B@use of limited amounts of givatiabie Pentostam, Pentastam treatment of cutaneous
/day for 20 days: In Theater) be reserved for sporaft cases or for patients
    who fall other measures.


         b. Katoconazole: Katoconazola is said to cure 70% of L. major disease and to be the treatment
    of choice in the Negev, Israel. L. tropics disease Is said to be resistant to ketoconazole.
    Katoconaxote Is a licensed antffungal agent that Is adminstered orally. Our IND covers New World
    cutaneous disease In which 600 mg once a day for 28 days was 70% curative for L. B.
    panamensis and L. mexicana disease, but less than 400/a curative for L. B. brazillonsis disease.
    The disadvantage of ketoconazole is that there Is a transient (-1 8 hour) 2/3 decrease In serum
    testosterone at the doses used. The decrease In testosterone Is not noticed by cllnlc patients.

         The committee recommended:

         --The;IND for katoconazole vs. lelshmaniasis be amended to Incfude an Associate
    Investigator in the Theater, a now form of cutaneous leishmaniasis (Old World disease), and an
    increase In the number of patients,

         --A protocol be written In which patients with Old World cutaneous disease are randomized
    between ketoconazole and p[moba.

         --An IND be prepared for the ketoconazole congenor ltraconazole. Itraconazole appears to
    be lsilghtly less effective than ketoconazolo In Central American cutaneous disease, but
    itraconazole (at 400 mg dally)has virtually no toxicity Including a lack of effect on
    toslosterone.

Document 4 f:/Week-36/BX003202/DESERT SHIELD MEDICAL ISSUES REVIEW AND AD HOC WORKING GROUP/operation desert shield and leishmanasis 19 dec :1011961539118
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003202
Unit = OTSG
Parent Organization = HSC
Folder Title = DESERT SHIELD MEDICAL ISSUES REVIEW AND AD HOC WORKING GROUP
Folder Seq # = 31
Subject = OPERATION DESERT SHIELD AND LEISHMANASIS 19 DEC
Document Seq # = 2
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 = 11-OCT-1996