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Comparison of 2 Doses of Liposomal Amphotericin B and Conventional Amphotericin B Deoxycholate for Treatment of AIDS-Associated Acute Cryptococcal Meningitis: A Randomized, Double-Blind Clinical Trial of Efficacy and Safety
Background. It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis. However, administration of this drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of highly active antiretrov...
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| Published in: | Clinical infectious diseases 2010-07, Vol.51 (2), p.225-232 |
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| container_title | Clinical infectious diseases |
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| creator | Hamill, Richard J. Sobel, Jack D. El-Sadr, Wafaa Johnson, Philip C. Graybill, John R. Javaly, Kedarnath Barker, David E. Baker, Carol J. |
| description | Background. It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis. However, administration of this drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of highly active antiretroviral therapy, was designed to compare the efficacy and safety of liposomal amphotericin B to conventional amphotericin deoxycholate in patients with acquired immunodeficiency syndrome (AIDS) and acute cryptococcal meningitis. Methods. Patients were randomized (ratio, 1:1:1) from multiple sites in the United States and Canada to receive either amphotericin B at 0.7 mg/kg/day (n=87), liposomal amphotericin B at 3 mg/kg/day (n=86), or liposomal amphotericin B at 6 mg/kg/day (n=94). Results. Efficacy was similar among all 3 treatment groups. The overall incidence of infusion-related reactions was significantly lower for both the 3 mg/kg/day and 6 mg/kg/day dosages of liposomal amphotericin B, compared with conventional amphotericin B (P |
| doi_str_mv | 10.1086/653606 |
| format | article |
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It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis. However, administration of this drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of highly active antiretroviral therapy, was designed to compare the efficacy and safety of liposomal amphotericin B to conventional amphotericin deoxycholate in patients with acquired immunodeficiency syndrome (AIDS) and acute cryptococcal meningitis. Methods. Patients were randomized (ratio, 1:1:1) from multiple sites in the United States and Canada to receive either amphotericin B at 0.7 mg/kg/day (n=87), liposomal amphotericin B at 3 mg/kg/day (n=86), or liposomal amphotericin B at 6 mg/kg/day (n=94). Results. Efficacy was similar among all 3 treatment groups. The overall incidence of infusion-related reactions was significantly lower for both the 3 mg/kg/day and 6 mg/kg/day dosages of liposomal amphotericin B, compared with conventional amphotericin B (P<.001). Significantly fewer patients who received the 3 mg/kg/day dosage of liposomal amphotericin B developed nephrotoxicity, indicated by a doubling of the serum creatinine value, compared with recipients of conventional amphotericin B (P=.004). Overall mortality at 10 weeks was 11.6%, with no significant differences among the treatment groups. Conclusions. Liposomal amphotericin B provides an equally efficacious alternative to conventional amphotericin B deoxycholate in patients with AIDS and acute cryptococcal meningitis. Liposomal amphotericin B at a dosage of 3 mg/kg/day is accompanied by significantly fewer adverse effects.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1086/653606</identifier><identifier>PMID: 20536366</identifier><identifier>CODEN: CIDIEL</identifier><language>eng</language><publisher>Oxford: The University of Chicago Press</publisher><subject>Adolescent ; Adult ; Aged ; AIDS ; AIDS-Related Opportunistic Infections - drug therapy ; Amphotericin B - administration & dosage ; Amphotericin B - adverse effects ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antifungal agents ; Antifungal Agents - administration & dosage ; Antifungal Agents - adverse effects ; Biological and medical sciences ; Canada ; Cerebrospinal fluid ; Child ; Comparative analysis ; Creatinine - blood ; Cryptococcal meningitis ; Deoxycholic Acid - administration & dosage ; Deoxycholic Acid - adverse effects ; Dosage ; Double-Blind Method ; Drug Combinations ; Effects ; Experimentation ; Female ; Fungal infections ; Highly active antiretroviral therapy ; HIV/AIDS ; Human mycoses ; Human viral diseases ; Humans ; Infectious diseases ; Kidney Diseases - chemically induced ; Lipids ; Male ; Medical sciences ; Medical treatment ; Meningitis ; Meningitis, Cryptococcal - drug therapy ; Meningitis, Cryptococcal - mortality ; Middle Aged ; Miscellaneous mycoses ; Mortality ; Mycoses ; Pharmacology. Drug treatments ; State hospitals ; Studies ; Treatment Outcome ; United States ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Young Adult</subject><ispartof>Clinical infectious diseases, 2010-07, Vol.51 (2), p.225-232</ispartof><rights>2010 Infectious Diseases Society of America</rights><rights>2010 by the Infectious Diseases Society of America 2010</rights><rights>2015 INIST-CNRS</rights><rights>Copyright University of Chicago, acting through its Press Jul 15, 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c519t-34aa52b03fbdf744f42a87d0b504d614f0eb4cebedf3ca2f385ee05601b40d9f3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/25680000$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/25680000$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,58238,58471</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22995147$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20536366$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hamill, Richard J.</creatorcontrib><creatorcontrib>Sobel, Jack D.</creatorcontrib><creatorcontrib>El-Sadr, Wafaa</creatorcontrib><creatorcontrib>Johnson, Philip C.</creatorcontrib><creatorcontrib>Graybill, John R.</creatorcontrib><creatorcontrib>Javaly, Kedarnath</creatorcontrib><creatorcontrib>Barker, David E.</creatorcontrib><creatorcontrib>Baker, Carol J.</creatorcontrib><title>Comparison of 2 Doses of Liposomal Amphotericin B and Conventional Amphotericin B Deoxycholate for Treatment of AIDS-Associated Acute Cryptococcal Meningitis: A Randomized, Double-Blind Clinical Trial of Efficacy and Safety</title><title>Clinical infectious diseases</title><addtitle>Clinical Infectious Diseases</addtitle><addtitle>Clinical Infectious Diseases</addtitle><description>Background. It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis. However, administration of this drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of highly active antiretroviral therapy, was designed to compare the efficacy and safety of liposomal amphotericin B to conventional amphotericin deoxycholate in patients with acquired immunodeficiency syndrome (AIDS) and acute cryptococcal meningitis. Methods. Patients were randomized (ratio, 1:1:1) from multiple sites in the United States and Canada to receive either amphotericin B at 0.7 mg/kg/day (n=87), liposomal amphotericin B at 3 mg/kg/day (n=86), or liposomal amphotericin B at 6 mg/kg/day (n=94). Results. Efficacy was similar among all 3 treatment groups. The overall incidence of infusion-related reactions was significantly lower for both the 3 mg/kg/day and 6 mg/kg/day dosages of liposomal amphotericin B, compared with conventional amphotericin B (P<.001). Significantly fewer patients who received the 3 mg/kg/day dosage of liposomal amphotericin B developed nephrotoxicity, indicated by a doubling of the serum creatinine value, compared with recipients of conventional amphotericin B (P=.004). Overall mortality at 10 weeks was 11.6%, with no significant differences among the treatment groups. Conclusions. Liposomal amphotericin B provides an equally efficacious alternative to conventional amphotericin B deoxycholate in patients with AIDS and acute cryptococcal meningitis. Liposomal amphotericin B at a dosage of 3 mg/kg/day is accompanied by significantly fewer adverse effects.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>AIDS</subject><subject>AIDS-Related Opportunistic Infections - drug therapy</subject><subject>Amphotericin B - administration & dosage</subject><subject>Amphotericin B - adverse effects</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antifungal agents</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antifungal Agents - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Canada</subject><subject>Cerebrospinal fluid</subject><subject>Child</subject><subject>Comparative analysis</subject><subject>Creatinine - blood</subject><subject>Cryptococcal meningitis</subject><subject>Deoxycholic Acid - administration & dosage</subject><subject>Deoxycholic Acid - adverse effects</subject><subject>Dosage</subject><subject>Double-Blind Method</subject><subject>Drug Combinations</subject><subject>Effects</subject><subject>Experimentation</subject><subject>Female</subject><subject>Fungal infections</subject><subject>Highly active antiretroviral therapy</subject><subject>HIV/AIDS</subject><subject>Human mycoses</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Kidney Diseases - chemically induced</subject><subject>Lipids</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Meningitis</subject><subject>Meningitis, Cryptococcal - drug therapy</subject><subject>Meningitis, Cryptococcal - mortality</subject><subject>Middle Aged</subject><subject>Miscellaneous mycoses</subject><subject>Mortality</subject><subject>Mycoses</subject><subject>Pharmacology. Drug treatments</subject><subject>State hospitals</subject><subject>Studies</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Young Adult</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><recordid>eNp1kc9u1DAQxiMEoqXAG4AMEpwI2PGfJNzS3UIrbYVEF1FxiRzHpl6STLAd1OVleRW8ZGkPCB_Go_l--mY0kySPCX5NcCHeCE4FFneSQ8Jpngpekrsxx7xIWUGLg-SB9xuMCSkwv58cZDjiVIjD5NcC-lE662FAYFCGluC136UrO4KHXnao6scrCNpZZQd0jOTQogUMP_QQLAz_6ksN11t1BZ0MGhlwaO20DH3Ed7bV2fIirbwHZaPeokpNEVu47RhAgVLR71wPdvhqg_VvUYU-xn7Q25-6fRWHm5pOp8ed3c0Qo93xa2djjN4nxsSC2v4Z8UIaHbYPk3tGdl4_2v9Hyad3J-vFabr68P5sUa1SxUkZUsqk5FmDqWlakzNmWCaLvMUNx6wVhBmsG6Z0o1tDlcwMLbjWmAtMGobb0tCj5PnsOzr4Pmkf6g1MLm7H1zwvWMFZRiP0coaUA--dNvXobC_dtia43p2xns8Ywad7t6npdXuD_b1bBF7sAenjCoyTg7L-lsvKkhOWR-7ZzME0_r_Zk5nZ-ADu1oOLAscX9XTWrQ_6-kaX7lstcprz-vTyS_2ZkqUoL89rQX8DyFvJzA</recordid><startdate>20100715</startdate><enddate>20100715</enddate><creator>Hamill, Richard J.</creator><creator>Sobel, Jack D.</creator><creator>El-Sadr, Wafaa</creator><creator>Johnson, Philip C.</creator><creator>Graybill, John R.</creator><creator>Javaly, Kedarnath</creator><creator>Barker, David E.</creator><creator>Baker, Carol J.</creator><general>The University of Chicago Press</general><general>University of Chicago Press</general><general>Oxford University Press</general><scope>BSCLL</scope><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>7T2</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>P64</scope></search><sort><creationdate>20100715</creationdate><title>Comparison of 2 Doses of Liposomal Amphotericin B and Conventional Amphotericin B Deoxycholate for Treatment of AIDS-Associated Acute Cryptococcal Meningitis: A Randomized, Double-Blind Clinical Trial of Efficacy and Safety</title><author>Hamill, Richard J. ; Sobel, Jack D. ; El-Sadr, Wafaa ; Johnson, Philip C. ; Graybill, John R. ; Javaly, Kedarnath ; Barker, David E. ; Baker, Carol J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c519t-34aa52b03fbdf744f42a87d0b504d614f0eb4cebedf3ca2f385ee05601b40d9f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>AIDS</topic><topic>AIDS-Related Opportunistic Infections - drug therapy</topic><topic>Amphotericin B - administration & dosage</topic><topic>Amphotericin B - adverse effects</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antifungal agents</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antifungal Agents - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Canada</topic><topic>Cerebrospinal fluid</topic><topic>Child</topic><topic>Comparative analysis</topic><topic>Creatinine - blood</topic><topic>Cryptococcal meningitis</topic><topic>Deoxycholic Acid - administration & dosage</topic><topic>Deoxycholic Acid - adverse effects</topic><topic>Dosage</topic><topic>Double-Blind Method</topic><topic>Drug Combinations</topic><topic>Effects</topic><topic>Experimentation</topic><topic>Female</topic><topic>Fungal infections</topic><topic>Highly active antiretroviral therapy</topic><topic>HIV/AIDS</topic><topic>Human mycoses</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Kidney Diseases - chemically induced</topic><topic>Lipids</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medical treatment</topic><topic>Meningitis</topic><topic>Meningitis, Cryptococcal - drug therapy</topic><topic>Meningitis, Cryptococcal - mortality</topic><topic>Middle Aged</topic><topic>Miscellaneous mycoses</topic><topic>Mortality</topic><topic>Mycoses</topic><topic>Pharmacology. Drug treatments</topic><topic>State hospitals</topic><topic>Studies</topic><topic>Treatment Outcome</topic><topic>United States</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hamill, Richard J.</creatorcontrib><creatorcontrib>Sobel, Jack D.</creatorcontrib><creatorcontrib>El-Sadr, Wafaa</creatorcontrib><creatorcontrib>Johnson, Philip C.</creatorcontrib><creatorcontrib>Graybill, John R.</creatorcontrib><creatorcontrib>Javaly, Kedarnath</creatorcontrib><creatorcontrib>Barker, David E.</creatorcontrib><creatorcontrib>Baker, Carol J.</creatorcontrib><collection>Istex</collection><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>Health and Safety Science Abstracts (Full archive)</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>Biotechnology and BioEngineering Abstracts</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hamill, Richard J.</au><au>Sobel, Jack D.</au><au>El-Sadr, Wafaa</au><au>Johnson, Philip C.</au><au>Graybill, John R.</au><au>Javaly, Kedarnath</au><au>Barker, David E.</au><au>Baker, Carol J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of 2 Doses of Liposomal Amphotericin B and Conventional Amphotericin B Deoxycholate for Treatment of AIDS-Associated Acute Cryptococcal Meningitis: A Randomized, Double-Blind Clinical Trial of Efficacy and Safety</atitle><jtitle>Clinical infectious diseases</jtitle><stitle>Clinical Infectious Diseases</stitle><addtitle>Clinical Infectious Diseases</addtitle><date>2010-07-15</date><risdate>2010</risdate><volume>51</volume><issue>2</issue><spage>225</spage><epage>232</epage><pages>225-232</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><coden>CIDIEL</coden><abstract>Background. It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis. However, administration of this drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of highly active antiretroviral therapy, was designed to compare the efficacy and safety of liposomal amphotericin B to conventional amphotericin deoxycholate in patients with acquired immunodeficiency syndrome (AIDS) and acute cryptococcal meningitis. Methods. Patients were randomized (ratio, 1:1:1) from multiple sites in the United States and Canada to receive either amphotericin B at 0.7 mg/kg/day (n=87), liposomal amphotericin B at 3 mg/kg/day (n=86), or liposomal amphotericin B at 6 mg/kg/day (n=94). Results. Efficacy was similar among all 3 treatment groups. The overall incidence of infusion-related reactions was significantly lower for both the 3 mg/kg/day and 6 mg/kg/day dosages of liposomal amphotericin B, compared with conventional amphotericin B (P<.001). Significantly fewer patients who received the 3 mg/kg/day dosage of liposomal amphotericin B developed nephrotoxicity, indicated by a doubling of the serum creatinine value, compared with recipients of conventional amphotericin B (P=.004). Overall mortality at 10 weeks was 11.6%, with no significant differences among the treatment groups. Conclusions. Liposomal amphotericin B provides an equally efficacious alternative to conventional amphotericin B deoxycholate in patients with AIDS and acute cryptococcal meningitis. Liposomal amphotericin B at a dosage of 3 mg/kg/day is accompanied by significantly fewer adverse effects.</abstract><cop>Oxford</cop><pub>The University of Chicago Press</pub><pmid>20536366</pmid><doi>10.1086/653606</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1058-4838 |
| ispartof | Clinical infectious diseases, 2010-07, Vol.51 (2), p.225-232 |
| issn | 1058-4838 1537-6591 |
| language | eng |
| recordid | cdi_proquest_journals_578485423 |
| source | JSTOR Archival Journals and Primary Sources Collection; Oxford Journals Online |
| subjects | Adolescent Adult Aged AIDS AIDS-Related Opportunistic Infections - drug therapy Amphotericin B - administration & dosage Amphotericin B - adverse effects Antibiotics. Antiinfectious agents. Antiparasitic agents Antifungal agents Antifungal Agents - administration & dosage Antifungal Agents - adverse effects Biological and medical sciences Canada Cerebrospinal fluid Child Comparative analysis Creatinine - blood Cryptococcal meningitis Deoxycholic Acid - administration & dosage Deoxycholic Acid - adverse effects Dosage Double-Blind Method Drug Combinations Effects Experimentation Female Fungal infections Highly active antiretroviral therapy HIV/AIDS Human mycoses Human viral diseases Humans Infectious diseases Kidney Diseases - chemically induced Lipids Male Medical sciences Medical treatment Meningitis Meningitis, Cryptococcal - drug therapy Meningitis, Cryptococcal - mortality Middle Aged Miscellaneous mycoses Mortality Mycoses Pharmacology. Drug treatments State hospitals Studies Treatment Outcome United States Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Young Adult |
| title | Comparison of 2 Doses of Liposomal Amphotericin B and Conventional Amphotericin B Deoxycholate for Treatment of AIDS-Associated Acute Cryptococcal Meningitis: A Randomized, Double-Blind Clinical Trial of Efficacy and Safety |
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