OPERATION DESERT SHIELD AND LEISHMANASIS 19 DEC 90

File: 102496_sep96_decls7_0004.txt
Page: 0004
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





              --All patients with cutaneous disease be randomlad between katoconazole and placebo
         (vitamin treatment) in a study situation, or be given katoconazole in a treatment situation.

              c@ Topical preparation containing Paromomycin: A topical preparation containing the
         antileishmanial agent paromomycin and an antifelahmanial disinfectant MBCL has been patented
         by TEVA, Israel and Is In trial against L. major in Israel. Anecdotal reports suggest that although
         the MBCL signicantly augments the ant[laishmanlat activity of the preparation in mdents, the
         MBCL does not Improve clinical efficacy in man. If MBCL Is not needed, then OlvET formulation
         (paromomycin plus gentamicin) will have activity equal to the MBCL formulation, and less
         toxicity because MBCL Is locally irritating. In addition, paromomyc(n can only be acquired from
         Farmitalla, Italy (or from the USSR), and Farmitalia is more likely to supply paromomycin to
         DoO than to a competing corporation.

              The committee recommended:

              --D!vET to draw up a plan to submit to the FDA for the preclinical toxicology and clinical
         evaluation of the DivET formulation. The plan to Include the request that clinical evaluation be
         simultaneous with prectinical toxicology (a "treatment IND"). USAMMDA to commit resources
         to perform precilnical toxicology.

              --An IND for @e TEVA formulation not be pursued at this time, but be pursued if Its
         perceived disadvantages no longer pertain. These disadvantages are: Inability of TEVA to obtain
         paromomycin, lack of added efficacy by addition of MBOL to the formulation, toxicity of MBCL.

         S. Summary of Recommendations:

              a. diagnosis- Medical assets In the Persian Gulf Region be trained by USAMRDC in the
         parasitological diagnosis of leishmaniasis by aspiration and biopsy. If only clinical diagnosis is
atients who do not In fact have lsishmantasts will be treated with potentially
         toxic drugs.

              b. T@atment:
                 Cutaneous disease: All patients with cutaneous disease be randomized between
         ketoconazole (600 mg once a day for 28 days: in Theater) and placebo (vitamin treatment) In a
         study situation, or be given ketoconazole In a treatment situation. Pentostam treatment of
         cutaneous disease (20 mg/kg/day for 20 days: In Theater) be reserved for sporate cases or for
         patients who fail katoconazole. @ause the optimum use of Pentostam (and ketooonazole)
         requires knowledge only available at USAMROC via 10 years of clinical Investigation, medical
         corps personnel in the Persian Gulf region should be made associate lnvestigatorsofthe
         USAMRDC Pentostam protocol and receive appropriate training.

           I  Visceral disease: All cases of visceral disease be given Pentostam (20 mg/kg/day for 30
         days), and be evacuated to WRAMC for this purpose.

              Note: Good treatment records should be centrally roposited at USAMRDC so that the
         experience of Operation Desert Shield can guide future treatment of DoE) forces.


         5 USC 522(b)(6)
                                                  @IIINLAT     BP-RMAN
                                                    Co , @
                                                           C
                                                   Chairman, MRDO Leishmaniasis Steering Committee

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