Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study
Optimal treatment for HIV-related visceral leishmaniasis (VL) has still to be established. A pilot clinical trial was carried out in 57 HIV-VL coinfected patients to compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate. The patients were randomized to r...
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| Veröffentlicht in: | Journal of antimicrobial chemotherapy 2003-09, Vol.52 (3), p.464-468 |
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| creator | LAGUNA, Fernando VIDELA, Sebastian ALVAR, Jorge JIMENEZ-MEJIAS, Manuel E SIRERA, Guillem TORRE-CISNEROS, Julian RIBERA, Esteban PRADOS, Dolores CLOTET, Bonaventura SUST, Mariano LOPEZ-VELEZ, Rogelio |
| description | Optimal treatment for HIV-related visceral leishmaniasis (VL) has still to be established. A pilot clinical trial was carried out in 57 HIV-VL coinfected patients to compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate. The patients were randomized to receive either ABLC 3 mg/kg/day for 5 days (ABLC-5, 18 patients), ABLC 3 mg/kg/day for 10 days (ABLC-10, 20 patients) or meglumine antimoniate 20 mg Sbv /kg/day for 28 days (19 patients). Treatment was considered successful if parasites were not detected in a bone marrow aspirate after treatment. Parasitological cure was attained in 33% (95% CI: 13%-59%) of the ABLC-5 group, in 42% (95% CI: 16%-62%) of the ABLC-10 group and in 37% (95% CI: 16%-62%) of the meglumine antimoniate group (P = 0.94). Eight out of 19 patients administered antimoniate discontinued treatment prematurely following serious adverse events, compared with one in the ABLC groups (P = 0.0006). The efficacy of ABLC is similar to meglumine antimoniate, but the severity of toxicity in the treatment of HIV-VL is lower with ABLC. |
| doi_str_mv | 10.1093/jac/dkg356 |
| format | Article |
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A pilot clinical trial was carried out in 57 HIV-VL coinfected patients to compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate. The patients were randomized to receive either ABLC 3 mg/kg/day for 5 days (ABLC-5, 18 patients), ABLC 3 mg/kg/day for 10 days (ABLC-10, 20 patients) or meglumine antimoniate 20 mg Sbv /kg/day for 28 days (19 patients). Treatment was considered successful if parasites were not detected in a bone marrow aspirate after treatment. Parasitological cure was attained in 33% (95% CI: 13%-59%) of the ABLC-5 group, in 42% (95% CI: 16%-62%) of the ABLC-10 group and in 37% (95% CI: 16%-62%) of the meglumine antimoniate group (P = 0.94). Eight out of 19 patients administered antimoniate discontinued treatment prematurely following serious adverse events, compared with one in the ABLC groups (P = 0.0006). The efficacy of ABLC is similar to meglumine antimoniate, but the severity of toxicity in the treatment of HIV-VL is lower with ABLC.</description><identifier>ISSN: 0305-7453</identifier><identifier>ISSN: 1460-2091</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkg356</identifier><identifier>PMID: 12888588</identifier><identifier>CODEN: JACHDX</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Adult ; Amphotericin B - administration & dosage ; Amphotericin B - adverse effects ; Amphotericin B - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiparasitic agents ; Antiprotozoal Agents - administration & dosage ; Antiprotozoal Agents - adverse effects ; Antiprotozoal Agents - therapeutic use ; Biological and medical sciences ; Bone Marrow - parasitology ; Double-Blind Method ; Drug Combinations ; Female ; HIV Infections - complications ; Human immunodeficiency virus ; Humans ; Leishmania ; Leishmaniasis, Visceral - complications ; Leishmaniasis, Visceral - drug therapy ; Leishmaniasis, Visceral - parasitology ; Male ; Medical sciences ; Meglumine - adverse effects ; Meglumine - therapeutic use ; meglumine antimoniate ; Organometallic Compounds - adverse effects ; Organometallic Compounds - therapeutic use ; Pharmacology. Drug treatments ; Phosphatidylcholines - administration & dosage ; Phosphatidylcholines - adverse effects ; Phosphatidylcholines - therapeutic use ; Phosphatidylglycerols - administration & dosage ; Phosphatidylglycerols - adverse effects ; Phosphatidylglycerols - therapeutic use ; Pilot Projects ; Treatment Outcome</subject><ispartof>Journal of antimicrobial chemotherapy, 2003-09, Vol.52 (3), p.464-468</ispartof><rights>2004 INIST-CNRS</rights><rights>Copyright Oxford University Press(England) Sep 2003</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c409t-a499cba69ea741d2f466a3534b41f6af2e1d71423a8b6c0fd5607fd66899fb673</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15091407$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12888588$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>LAGUNA, Fernando</creatorcontrib><creatorcontrib>VIDELA, Sebastian</creatorcontrib><creatorcontrib>ALVAR, Jorge</creatorcontrib><creatorcontrib>JIMENEZ-MEJIAS, Manuel E</creatorcontrib><creatorcontrib>SIRERA, Guillem</creatorcontrib><creatorcontrib>TORRE-CISNEROS, Julian</creatorcontrib><creatorcontrib>RIBERA, Esteban</creatorcontrib><creatorcontrib>PRADOS, Dolores</creatorcontrib><creatorcontrib>CLOTET, Bonaventura</creatorcontrib><creatorcontrib>SUST, Mariano</creatorcontrib><creatorcontrib>LOPEZ-VELEZ, Rogelio</creatorcontrib><creatorcontrib>Spanish HIV-Leishmania Study Group</creatorcontrib><title>Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Optimal treatment for HIV-related visceral leishmaniasis (VL) has still to be established. A pilot clinical trial was carried out in 57 HIV-VL coinfected patients to compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate. The patients were randomized to receive either ABLC 3 mg/kg/day for 5 days (ABLC-5, 18 patients), ABLC 3 mg/kg/day for 10 days (ABLC-10, 20 patients) or meglumine antimoniate 20 mg Sbv /kg/day for 28 days (19 patients). Treatment was considered successful if parasites were not detected in a bone marrow aspirate after treatment. Parasitological cure was attained in 33% (95% CI: 13%-59%) of the ABLC-5 group, in 42% (95% CI: 16%-62%) of the ABLC-10 group and in 37% (95% CI: 16%-62%) of the meglumine antimoniate group (P = 0.94). Eight out of 19 patients administered antimoniate discontinued treatment prematurely following serious adverse events, compared with one in the ABLC groups (P = 0.0006). The efficacy of ABLC is similar to meglumine antimoniate, but the severity of toxicity in the treatment of HIV-VL is lower with ABLC.</description><subject>Adult</subject><subject>Amphotericin B - administration & dosage</subject><subject>Amphotericin B - adverse effects</subject><subject>Amphotericin B - therapeutic use</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiparasitic agents</subject><subject>Antiprotozoal Agents - administration & dosage</subject><subject>Antiprotozoal Agents - adverse effects</subject><subject>Antiprotozoal Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Bone Marrow - parasitology</subject><subject>Double-Blind Method</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>HIV Infections - complications</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Leishmania</subject><subject>Leishmaniasis, Visceral - complications</subject><subject>Leishmaniasis, Visceral - drug therapy</subject><subject>Leishmaniasis, Visceral - parasitology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Meglumine - adverse effects</subject><subject>Meglumine - therapeutic use</subject><subject>meglumine antimoniate</subject><subject>Organometallic Compounds - adverse effects</subject><subject>Organometallic Compounds - therapeutic use</subject><subject>Pharmacology. Drug treatments</subject><subject>Phosphatidylcholines - administration & dosage</subject><subject>Phosphatidylcholines - adverse effects</subject><subject>Phosphatidylcholines - therapeutic use</subject><subject>Phosphatidylglycerols - administration & dosage</subject><subject>Phosphatidylglycerols - adverse effects</subject><subject>Phosphatidylglycerols - therapeutic use</subject><subject>Pilot Projects</subject><subject>Treatment Outcome</subject><issn>0305-7453</issn><issn>1460-2091</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpd0cFuFCEYwHFiNHatXnwAQ0z0YDIWBoYZequN2iZNvKjXCQMfXVYYRmCq9Vl8WNnsJk08QcgvX4A_Qi8peU-JZGc7pc_Mj1vWiUdoQ7kgTUskfYw2hJGu6XnHTtCznHeEENGJ4Sk6oe0wDN0wbNDfi7BsY4HktJvxB-zd4gzWMSwefuM7SHnNOMCtX4ObAau5uBBnpwrg6ssWcEmgSoC54GjxncsakvLYg8vboKrMLu_pooqraL-3oAsY_MuVLb66_n6OFU5qNjG4P_V4cT4WnMtq7p-jJ1b5DC-O6yn69unj18ur5ubL5-vLi5tGcyJLo7iUelJCguo5Na3lQijWMT5xaoWyLVDTU94yNUxCE2s6QXprhBiktJPo2Sl6e5i7pPhzhVzGsH-H92qGuOaRyraTjPMKX_8Hd3FNc73b2NJeCCYIq-jdAekUc05gxyW5oNL9SMm4DzbWYOMhWMWvjhPXKYB5oMdCFbw5ApW18rb-lHb5wXU1NSc9-wfMJ6Hd</recordid><startdate>20030901</startdate><enddate>20030901</enddate><creator>LAGUNA, Fernando</creator><creator>VIDELA, Sebastian</creator><creator>ALVAR, Jorge</creator><creator>JIMENEZ-MEJIAS, Manuel E</creator><creator>SIRERA, Guillem</creator><creator>TORRE-CISNEROS, Julian</creator><creator>RIBERA, Esteban</creator><creator>PRADOS, Dolores</creator><creator>CLOTET, Bonaventura</creator><creator>SUST, Mariano</creator><creator>LOPEZ-VELEZ, Rogelio</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QO</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope></search><sort><creationdate>20030901</creationdate><title>Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study</title><author>LAGUNA, Fernando ; VIDELA, Sebastian ; ALVAR, Jorge ; JIMENEZ-MEJIAS, Manuel E ; SIRERA, Guillem ; TORRE-CISNEROS, Julian ; RIBERA, Esteban ; PRADOS, Dolores ; CLOTET, Bonaventura ; SUST, Mariano ; LOPEZ-VELEZ, Rogelio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c409t-a499cba69ea741d2f466a3534b41f6af2e1d71423a8b6c0fd5607fd66899fb673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Adult</topic><topic>Amphotericin B - administration & dosage</topic><topic>Amphotericin B - adverse effects</topic><topic>Amphotericin B - therapeutic use</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiparasitic agents</topic><topic>Antiprotozoal Agents - administration & dosage</topic><topic>Antiprotozoal Agents - adverse effects</topic><topic>Antiprotozoal Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Bone Marrow - parasitology</topic><topic>Double-Blind Method</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>HIV Infections - complications</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Leishmania</topic><topic>Leishmaniasis, Visceral - complications</topic><topic>Leishmaniasis, Visceral - drug therapy</topic><topic>Leishmaniasis, Visceral - parasitology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Meglumine - adverse effects</topic><topic>Meglumine - therapeutic use</topic><topic>meglumine antimoniate</topic><topic>Organometallic Compounds - adverse effects</topic><topic>Organometallic Compounds - therapeutic use</topic><topic>Pharmacology. Drug treatments</topic><topic>Phosphatidylcholines - administration & dosage</topic><topic>Phosphatidylcholines - adverse effects</topic><topic>Phosphatidylcholines - therapeutic use</topic><topic>Phosphatidylglycerols - administration & dosage</topic><topic>Phosphatidylglycerols - adverse effects</topic><topic>Phosphatidylglycerols - therapeutic use</topic><topic>Pilot Projects</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>LAGUNA, Fernando</creatorcontrib><creatorcontrib>VIDELA, Sebastian</creatorcontrib><creatorcontrib>ALVAR, Jorge</creatorcontrib><creatorcontrib>JIMENEZ-MEJIAS, Manuel E</creatorcontrib><creatorcontrib>SIRERA, Guillem</creatorcontrib><creatorcontrib>TORRE-CISNEROS, Julian</creatorcontrib><creatorcontrib>RIBERA, Esteban</creatorcontrib><creatorcontrib>PRADOS, Dolores</creatorcontrib><creatorcontrib>CLOTET, Bonaventura</creatorcontrib><creatorcontrib>SUST, Mariano</creatorcontrib><creatorcontrib>LOPEZ-VELEZ, Rogelio</creatorcontrib><creatorcontrib>Spanish HIV-Leishmania Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>LAGUNA, Fernando</au><au>VIDELA, Sebastian</au><au>ALVAR, Jorge</au><au>JIMENEZ-MEJIAS, Manuel E</au><au>SIRERA, Guillem</au><au>TORRE-CISNEROS, Julian</au><au>RIBERA, Esteban</au><au>PRADOS, Dolores</au><au>CLOTET, Bonaventura</au><au>SUST, Mariano</au><au>LOPEZ-VELEZ, Rogelio</au><aucorp>Spanish HIV-Leishmania Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2003-09-01</date><risdate>2003</risdate><volume>52</volume><issue>3</issue><spage>464</spage><epage>468</epage><pages>464-468</pages><issn>0305-7453</issn><issn>1460-2091</issn><eissn>1460-2091</eissn><coden>JACHDX</coden><abstract>Optimal treatment for HIV-related visceral leishmaniasis (VL) has still to be established. A pilot clinical trial was carried out in 57 HIV-VL coinfected patients to compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate. The patients were randomized to receive either ABLC 3 mg/kg/day for 5 days (ABLC-5, 18 patients), ABLC 3 mg/kg/day for 10 days (ABLC-10, 20 patients) or meglumine antimoniate 20 mg Sbv /kg/day for 28 days (19 patients). Treatment was considered successful if parasites were not detected in a bone marrow aspirate after treatment. Parasitological cure was attained in 33% (95% CI: 13%-59%) of the ABLC-5 group, in 42% (95% CI: 16%-62%) of the ABLC-10 group and in 37% (95% CI: 16%-62%) of the meglumine antimoniate group (P = 0.94). Eight out of 19 patients administered antimoniate discontinued treatment prematurely following serious adverse events, compared with one in the ABLC groups (P = 0.0006). The efficacy of ABLC is similar to meglumine antimoniate, but the severity of toxicity in the treatment of HIV-VL is lower with ABLC.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>12888588</pmid><doi>10.1093/jac/dkg356</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0305-7453 |
| ispartof | Journal of antimicrobial chemotherapy, 2003-09, Vol.52 (3), p.464-468 |
| issn | 0305-7453 1460-2091 1460-2091 |
| language | eng |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Free Full-Text Journals in Chemistry |
| subjects | Adult Amphotericin B - administration & dosage Amphotericin B - adverse effects Amphotericin B - therapeutic use Antibiotics. Antiinfectious agents. Antiparasitic agents Antiparasitic agents Antiprotozoal Agents - administration & dosage Antiprotozoal Agents - adverse effects Antiprotozoal Agents - therapeutic use Biological and medical sciences Bone Marrow - parasitology Double-Blind Method Drug Combinations Female HIV Infections - complications Human immunodeficiency virus Humans Leishmania Leishmaniasis, Visceral - complications Leishmaniasis, Visceral - drug therapy Leishmaniasis, Visceral - parasitology Male Medical sciences Meglumine - adverse effects Meglumine - therapeutic use meglumine antimoniate Organometallic Compounds - adverse effects Organometallic Compounds - therapeutic use Pharmacology. Drug treatments Phosphatidylcholines - administration & dosage Phosphatidylcholines - adverse effects Phosphatidylcholines - therapeutic use Phosphatidylglycerols - administration & dosage Phosphatidylglycerols - adverse effects Phosphatidylglycerols - therapeutic use Pilot Projects Treatment Outcome |
| title | Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study |
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