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Antiprotozoal agents / Neglected diseases / Antifungals / Visceral leishmaniasis / Leishmaniasis / Miltefosine / Amphotericin B / Sodium stibogluconate / Drugs for Neglected Diseases Initiative / Medicine / Microbiology / Health


CLINICAL TRIAL PROTOCOL A randomized trial of AmBisome® monotherapy and combination of AmBisome® and miltefosine for the treatment of VL in HIV positive patients in Ethiopia followed by secondary VL prophylactic treat
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Document Date: 2014-10-14 06:11:40


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Company

Version ABLC AE / Compassionate / Alteon Inc. / /

Continent

Africa / /

Country

Brazil / Ethiopia / India / /

Event

FDA Phase / /

Facility

Institute of Tropical Medicine / College of Health Sciences / Slotervaart Hospital / Harmonization Intramuscular Institute of Tropical Medecine Intention / MSF Operational Centre / /

IndustryTerm

contraceptive device / /

MedicalCondition

HIV / Neglected Diseases / pancreatitis / visceral leishmaniasis / /

MedicalTreatment

Anti-Retroviral Therapy / HAART / /

Organization

Institutional Review Board/Independent Ethics Committee / Slotervaart Hospital / World Health Organization / Gondar University / Food and Drug Administration / College of Health Sciences / Institute of Tropical Medicine / FDA / London School of Hygiene and Tropical Medicine / Harmonization Intramuscular Institute of Tropical Medecine Intention / London School of Hygiene / /

Person

Sisay Yifru / Koert Ritmeijer / Ermias Diro / Johan / VL VCT WBC / Thomas Dorlo / Stille Kolja / Ed Zijlstra / Neal Alexander / Asrat Hailu / Nathalie Strub-Wourgaft / Sally Ellis / Louis Dunant / /

/

Position

Investigator / available Miltefosine Messenger / Abdurafi site investigator / Name Title Institution Country Principal Investigator / Version Coordinating Investigator/Principal Investigator / representative / Transcriptase Inhibitor Nevirapine P-glycoprotein Principal investigator / site investigator / General / /

Product

AmBisome / Efavirenz / Zidovudine / amphotericin B / Nevirapine / Lamivudine / AmBisome® / India / Cure Upper Limit / /

ProvinceOrState

São Paulo / /

Region

Latin America / East Africa / Mediterranean / /

Technology

Pharmacokinetics / 61 Protocol / CLINICAL TRIAL PROTOCOL / patients Protocol / /

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