Didanosine in HIV-1–Infected Patients Experiencing Failure of Antiretroviral Therapy: A Randomized Placebo-Controlled Trial
BackgroundThe antiviral efficacy of didanosine in patients experiencing virological failure is not well known MethodsA total of 168 patients (139 men and 29 women) receiving stable antiretroviral therapy with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 1000–100,000 copies/mL wer...
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| Veröffentlicht in: | The Journal of infectious diseases 2005-03, Vol.191 (6), p.840-847 |
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| creator | Molina, Jean-Michel Marcelin, Anne-Geneviève Pavie, Juliette Heripret, Laurence De Boever, Corinne Merle Troccaz, Martine Leleu, Ghislaine |
| description | BackgroundThe antiviral efficacy of didanosine in patients experiencing virological failure is not well known MethodsA total of 168 patients (139 men and 29 women) receiving stable antiretroviral therapy with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 1000–100,000 copies/mL were randomly assigned to have didanosine (n=111) or placebo (n=57) added to their currently failing regimen for 4 weeks. The primary efficacy end point was the change in HIV-1 RNA level from baseline to week 4 ResultsAt baseline, the median HIV-1 RNA level was 3.8 log10 copies/mL, the median CD4 cell count was 378 cells/mm3, and the median number of nucleoside reverse-transcriptase inhibitor–associated mutations (NAMs) was 4. At week 4, a significant decrease in the median HIV-1 RNA level was observed in the didanosine group, compared with that in the placebo group (−0.56 vs. +0.07 log10 copies/mL, respectively) (P |
| doi_str_mv | 10.1086/428094 |
| format | Article |
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The primary efficacy end point was the change in HIV-1 RNA level from baseline to week 4 ResultsAt baseline, the median HIV-1 RNA level was 3.8 log10 copies/mL, the median CD4 cell count was 378 cells/mm3, and the median number of nucleoside reverse-transcriptase inhibitor–associated mutations (NAMs) was 4. At week 4, a significant decrease in the median HIV-1 RNA level was observed in the didanosine group, compared with that in the placebo group (−0.56 vs. +0.07 log10 copies/mL, respectively) (P<.0001). A total of 33 patients (31%) in the didanosine group, compared with 3 (6%) in the placebo group, had HIV-1 RNA levels <400 copies/mL (P<.001). Significant antiviral activity of didanosine was observed in patients with up to 5 NAMs at baseline. Diarrhea occurred in 5 patients (5%) in the didanosine group and 2 patients (4%) in the placebo group ConclusionsIn HIV-1–infected patients experiencing failure of antiretroviral therapy, didanosine retains short-term antiviral activity</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1086/428094</identifier><identifier>PMID: 15717257</identifier><identifier>CODEN: JIDIAQ</identifier><language>eng</language><publisher>Chicago, IL: The University of Chicago Press</publisher><subject>Adult ; Aged ; AIDS ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Antiretrovirals ; Antivirals ; Biological and medical sciences ; Didanosine - adverse effects ; Didanosine - therapeutic use ; Double-Blind Method ; Drug Resistance, Viral - genetics ; Drug Therapy, Combination ; Experimentation ; Female ; Fundamental and applied biological sciences. Psychology ; Genetic mutation ; HIV 1 ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV Reverse Transcriptase - genetics ; HIV-1 - drug effects ; HIV/AIDS ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Infectious diseases ; Male ; Medical sciences ; Medical treatment failures ; Microbiology ; Middle Aged ; Mutation ; Placebos ; Reverse Transcriptase Inhibitors - adverse effects ; Reverse Transcriptase Inhibitors - therapeutic use ; RNA ; RNA, Viral - blood ; Statistical median ; Treatment Failure ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids</subject><ispartof>The Journal of infectious diseases, 2005-03, Vol.191 (6), p.840-847</ispartof><rights>Copyright 2005 Infectious Diseases Society of America</rights><rights>2005 by the Infectious Diseases Society of America 2005</rights><rights>2005 INIST-CNRS</rights><rights>Copyright University of Chicago Press Mar 15, 2005</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c483t-29b4a69f1959e90941df96d084a5381b71b66ead1c4b96a27ef02076e112cc2a3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/30078540$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/30078540$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,777,781,800,27905,27906,57998,58231</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16699206$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15717257$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Molina, Jean-Michel</creatorcontrib><creatorcontrib>Marcelin, Anne-Geneviève</creatorcontrib><creatorcontrib>Pavie, Juliette</creatorcontrib><creatorcontrib>Heripret, Laurence</creatorcontrib><creatorcontrib>De Boever, Corinne Merle</creatorcontrib><creatorcontrib>Troccaz, Martine</creatorcontrib><creatorcontrib>Leleu, Ghislaine</creatorcontrib><creatorcontrib>AI454-176 JAGUAR Study Team</creatorcontrib><creatorcontrib>AI454-176 JAGUAR Study Team</creatorcontrib><creatorcontrib>AI454‐176 JAGUAR Study Team</creatorcontrib><title>Didanosine in HIV-1–Infected Patients Experiencing Failure of Antiretroviral Therapy: A Randomized Placebo-Controlled Trial</title><title>The Journal of infectious diseases</title><addtitle>The Journal of Infectious Diseases</addtitle><addtitle>The Journal of Infectious Diseases</addtitle><description>BackgroundThe antiviral efficacy of didanosine in patients experiencing virological failure is not well known MethodsA total of 168 patients (139 men and 29 women) receiving stable antiretroviral therapy with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 1000–100,000 copies/mL were randomly assigned to have didanosine (n=111) or placebo (n=57) added to their currently failing regimen for 4 weeks. The primary efficacy end point was the change in HIV-1 RNA level from baseline to week 4 ResultsAt baseline, the median HIV-1 RNA level was 3.8 log10 copies/mL, the median CD4 cell count was 378 cells/mm3, and the median number of nucleoside reverse-transcriptase inhibitor–associated mutations (NAMs) was 4. At week 4, a significant decrease in the median HIV-1 RNA level was observed in the didanosine group, compared with that in the placebo group (−0.56 vs. +0.07 log10 copies/mL, respectively) (P<.0001). A total of 33 patients (31%) in the didanosine group, compared with 3 (6%) in the placebo group, had HIV-1 RNA levels <400 copies/mL (P<.001). Significant antiviral activity of didanosine was observed in patients with up to 5 NAMs at baseline. Diarrhea occurred in 5 patients (5%) in the didanosine group and 2 patients (4%) in the placebo group ConclusionsIn HIV-1–infected patients experiencing failure of antiretroviral therapy, didanosine retains short-term antiviral activity</description><subject>Adult</subject><subject>Aged</subject><subject>AIDS</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretrovirals</subject><subject>Antivirals</subject><subject>Biological and medical sciences</subject><subject>Didanosine - adverse effects</subject><subject>Didanosine - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Drug Resistance, Viral - genetics</subject><subject>Drug Therapy, Combination</subject><subject>Experimentation</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Genetic mutation</subject><subject>HIV 1</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - virology</subject><subject>HIV Reverse Transcriptase - genetics</subject><subject>HIV-1 - drug effects</subject><subject>HIV/AIDS</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medical treatment failures</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Mutation</subject><subject>Placebos</subject><subject>Reverse Transcriptase Inhibitors - adverse effects</subject><subject>Reverse Transcriptase Inhibitors - therapeutic use</subject><subject>RNA</subject><subject>RNA, Viral - blood</subject><subject>Statistical median</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10duK1DAYB_Agijuu-gZKFfSumlNz8G4Yd3YG1iPjAW9CmqaasZPUpJVdQfAdfEOfxCwddkDwKiHfj3-S7wPgLoJPEBTsKcUCSnoNzFBFeMkYItfBDEKMSySkPAK3UtpCCClh_CY4QhVHHFd8Bn4-d432ITlvC-eL1fp9if78-r32rTWDbYrXenDWD6k4Oe9tzFvj_OdiqV03RluEtpj7wUU7xPDdRd0Vmy826v7iWTEv3mrfhJ37cZnSaWPrUC6Cz7Lr8tEmOt3dBjda3SV7Z78eg3fLk81iVZ69Ol0v5meloYIMJZY11Uy2SFbSyvxP1LSSNVBQXRGBao5qxqxukKG1ZBpz20IMObMIYWOwJsfg8ZTbx_BttGlQO5eM7TrtbRiTQlwgCBnN8OE_cBvG6PPbFMZEQlEJckgzMaQUbav66HY6XigE1eU01DSNDO_v08Z6Z5sD27c_g0d7oJPRXRt17m86OMakxJBl92ByYez_f9m9yWzTEOKVIhByUVGY6-VUd2mw51d1Hb8qxgmv1OrjJ_XydPnhjSAvFCV_ARm1tAA</recordid><startdate>20050315</startdate><enddate>20050315</enddate><creator>Molina, Jean-Michel</creator><creator>Marcelin, Anne-Geneviève</creator><creator>Pavie, Juliette</creator><creator>Heripret, Laurence</creator><creator>De Boever, Corinne Merle</creator><creator>Troccaz, Martine</creator><creator>Leleu, Ghislaine</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>K9.</scope><scope>NAPCQ</scope><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>20050315</creationdate><title>Didanosine in HIV-1–Infected Patients Experiencing Failure of Antiretroviral Therapy: A Randomized Placebo-Controlled Trial</title><author>Molina, Jean-Michel ; Marcelin, Anne-Geneviève ; Pavie, Juliette ; Heripret, Laurence ; De Boever, Corinne Merle ; Troccaz, Martine ; Leleu, Ghislaine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c483t-29b4a69f1959e90941df96d084a5381b71b66ead1c4b96a27ef02076e112cc2a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Aged</topic><topic>AIDS</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretrovirals</topic><topic>Antivirals</topic><topic>Biological and medical sciences</topic><topic>Didanosine - adverse effects</topic><topic>Didanosine - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Drug Resistance, Viral - genetics</topic><topic>Drug Therapy, Combination</topic><topic>Experimentation</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Genetic mutation</topic><topic>HIV 1</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - virology</topic><topic>HIV Reverse Transcriptase - genetics</topic><topic>HIV-1 - drug effects</topic><topic>HIV/AIDS</topic><topic>Human immunodeficiency virus 1</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medical treatment failures</topic><topic>Microbiology</topic><topic>Middle Aged</topic><topic>Mutation</topic><topic>Placebos</topic><topic>Reverse Transcriptase Inhibitors - adverse effects</topic><topic>Reverse Transcriptase Inhibitors - therapeutic use</topic><topic>RNA</topic><topic>RNA, Viral - blood</topic><topic>Statistical median</topic><topic>Treatment Failure</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Molina, Jean-Michel</creatorcontrib><creatorcontrib>Marcelin, Anne-Geneviève</creatorcontrib><creatorcontrib>Pavie, Juliette</creatorcontrib><creatorcontrib>Heripret, Laurence</creatorcontrib><creatorcontrib>De Boever, Corinne Merle</creatorcontrib><creatorcontrib>Troccaz, Martine</creatorcontrib><creatorcontrib>Leleu, Ghislaine</creatorcontrib><creatorcontrib>AI454-176 JAGUAR Study Team</creatorcontrib><creatorcontrib>AI454-176 JAGUAR Study Team</creatorcontrib><creatorcontrib>AI454‐176 JAGUAR Study Team</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>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Molina, Jean-Michel</au><au>Marcelin, Anne-Geneviève</au><au>Pavie, Juliette</au><au>Heripret, Laurence</au><au>De Boever, Corinne Merle</au><au>Troccaz, Martine</au><au>Leleu, Ghislaine</au><aucorp>AI454-176 JAGUAR Study Team</aucorp><aucorp>AI454-176 JAGUAR Study Team</aucorp><aucorp>AI454‐176 JAGUAR Study Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Didanosine in HIV-1–Infected Patients Experiencing Failure of Antiretroviral Therapy: A Randomized Placebo-Controlled Trial</atitle><jtitle>The Journal of infectious diseases</jtitle><stitle>The Journal of Infectious Diseases</stitle><addtitle>The Journal of Infectious Diseases</addtitle><date>2005-03-15</date><risdate>2005</risdate><volume>191</volume><issue>6</issue><spage>840</spage><epage>847</epage><pages>840-847</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><coden>JIDIAQ</coden><abstract>BackgroundThe antiviral efficacy of didanosine in patients experiencing virological failure is not well known MethodsA total of 168 patients (139 men and 29 women) receiving stable antiretroviral therapy with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 1000–100,000 copies/mL were randomly assigned to have didanosine (n=111) or placebo (n=57) added to their currently failing regimen for 4 weeks. The primary efficacy end point was the change in HIV-1 RNA level from baseline to week 4 ResultsAt baseline, the median HIV-1 RNA level was 3.8 log10 copies/mL, the median CD4 cell count was 378 cells/mm3, and the median number of nucleoside reverse-transcriptase inhibitor–associated mutations (NAMs) was 4. At week 4, a significant decrease in the median HIV-1 RNA level was observed in the didanosine group, compared with that in the placebo group (−0.56 vs. +0.07 log10 copies/mL, respectively) (P<.0001). A total of 33 patients (31%) in the didanosine group, compared with 3 (6%) in the placebo group, had HIV-1 RNA levels <400 copies/mL (P<.001). Significant antiviral activity of didanosine was observed in patients with up to 5 NAMs at baseline. Diarrhea occurred in 5 patients (5%) in the didanosine group and 2 patients (4%) in the placebo group ConclusionsIn HIV-1–infected patients experiencing failure of antiretroviral therapy, didanosine retains short-term antiviral activity</abstract><cop>Chicago, IL</cop><pub>The University of Chicago Press</pub><pmid>15717257</pmid><doi>10.1086/428094</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged AIDS Anti-HIV Agents - adverse effects Anti-HIV Agents - therapeutic use Antiretrovirals Antivirals Biological and medical sciences Didanosine - adverse effects Didanosine - therapeutic use Double-Blind Method Drug Resistance, Viral - genetics Drug Therapy, Combination Experimentation Female Fundamental and applied biological sciences. Psychology Genetic mutation HIV 1 HIV Infections - drug therapy HIV Infections - virology HIV Reverse Transcriptase - genetics HIV-1 - drug effects HIV/AIDS Human immunodeficiency virus 1 Human viral diseases Humans Infectious diseases Male Medical sciences Medical treatment failures Microbiology Middle Aged Mutation Placebos Reverse Transcriptase Inhibitors - adverse effects Reverse Transcriptase Inhibitors - therapeutic use RNA RNA, Viral - blood Statistical median Treatment Failure Treatment Outcome Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
| title | Didanosine in HIV-1–Infected Patients Experiencing Failure of Antiretroviral Therapy: A Randomized Placebo-Controlled Trial |
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