A Randomized Factorial Trial Comparing 4 Treatment Regimens in Treatment-Naive HIV-Infected Persons with AIDS and/or a CD4 Cell Count <200 Cells/μL in South Africa
Few randomized trials comparing antiretroviral therapy (ART) regimens have been conducted in resource-limited settings. In the Republic of South Africa, antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals >14 years old with a CD4 cell count
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| Veröffentlicht in: | The Journal of infectious diseases 2010-11, Vol.202 (10), p.1529-1537 |
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| container_title | The Journal of infectious diseases |
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| creator | Ratsela, Andrew Polis, Michael Dhlomo, Sibongiseni Emery, Sean Grandits, Greg Khabo, Paul Khanyile, Thandeka Komati, Stephanus Neaton, James D Naidoo, Lionel Chris David Magongoa, Daphne Qolohle, Duma |
| description | Few randomized trials comparing antiretroviral therapy (ART) regimens have been conducted in resource-limited settings.
In the Republic of South Africa, antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals >14 years old with a CD4 cell count |
| doi_str_mv | 10.1086/656718 |
| format | Article |
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In the Republic of South Africa, antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals >14 years old with a CD4 cell count <200 cells/μL or a prior AIDS diagnosis were randomized to receive efavirenz (EFV) or lopinavir/ritonavir (LPV/r) with either zidovudine (ZDV) plus didanosine (ddI) or stavudine (d4T) plus lamivudine (3TC) in an open-label, 2-by-2 factorial study and followed up for the primary outcome of AIDS or death and prespecified secondary outcomes, including CD4 cell count and viral load changes, treatment discontinuation, and grade 4 events.
In total, 1771 persons were randomized and followed up for a median of 24.7 months. AIDS or death occurred in (1) 163 participants assigned EFV and 157 assigned LPV/r (hazard ratio [HR], 1.04 [95% confidence interval {CI}, 0.84-1.30]) and in (2) 170 participants assigned ZDV+ddI and 150 assigned d4T+3TC (HR, 1.15 [95% CI, 0.93-1.44]). HIV RNA levels were lower (P < .001) and CD4 cell counts were greater (P < .01) over follow-up for d4T+3TC versus ZDV+ddI. Rates of potentially life-threatening adverse events and overall treatment discontinuation were similar for d4T+3TC and ZDV+ddI; however, more participants discontinued d4T because of toxicity (12.6%) than other treatments (<5%).
EFV and LPV/r are effective components of first-line ART. The poorer viral and immune responses with ZDV+ddI and the greater toxicity-associated discontinuation rate with d4T+3TC suggest that these treatments be used cautiously as initial therapy.
ClinicalTrials.gov identifier: NCT00342355.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1086/656718</identifier><identifier>PMID: 20942650</identifier><identifier>CODEN: JIDIAQ</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Acquired Immunodeficiency Syndrome - complications ; Acquired Immunodeficiency Syndrome - drug therapy ; Acquired Immunodeficiency Syndrome - immunology ; Acquired Immunodeficiency Syndrome - virology ; Adult ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Benzoxazines - therapeutic use ; Biological and medical sciences ; CD4 Lymphocyte Count ; Didanosine - adverse effects ; Didanosine - therapeutic use ; Drug Therapy, Combination ; Female ; HIV - genetics ; Human viral diseases ; Humans ; Infectious diseases ; Lamivudine - adverse effects ; Lamivudine - therapeutic use ; Lopinavir ; Male ; Medical sciences ; Pyrimidinones - therapeutic use ; Ritonavir - therapeutic use ; RNA, Viral - blood ; South Africa ; Stavudine - adverse effects ; Stavudine - therapeutic use ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Zidovudine - adverse effects ; Zidovudine - therapeutic use</subject><ispartof>The Journal of infectious diseases, 2010-11, Vol.202 (10), p.1529-1537</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c340t-65ed1f94ba78c81b426779c7c4ddc5bbf459c633d9d88d20f7b8d791d63af2663</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23393488$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20942650$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ratsela, Andrew</creatorcontrib><creatorcontrib>Polis, Michael</creatorcontrib><creatorcontrib>Dhlomo, Sibongiseni</creatorcontrib><creatorcontrib>Emery, Sean</creatorcontrib><creatorcontrib>Grandits, Greg</creatorcontrib><creatorcontrib>Khabo, Paul</creatorcontrib><creatorcontrib>Khanyile, Thandeka</creatorcontrib><creatorcontrib>Komati, Stephanus</creatorcontrib><creatorcontrib>Neaton, James D</creatorcontrib><creatorcontrib>Naidoo, Lionel Chris David</creatorcontrib><creatorcontrib>Magongoa, Daphne</creatorcontrib><creatorcontrib>Qolohle, Duma</creatorcontrib><creatorcontrib>Phidisa II Writing Team for Project Phidisa</creatorcontrib><title>A Randomized Factorial Trial Comparing 4 Treatment Regimens in Treatment-Naive HIV-Infected Persons with AIDS and/or a CD4 Cell Count <200 Cells/μL in South Africa</title><title>The Journal of infectious diseases</title><addtitle>J Infect Dis</addtitle><description>Few randomized trials comparing antiretroviral therapy (ART) regimens have been conducted in resource-limited settings.
In the Republic of South Africa, antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals >14 years old with a CD4 cell count <200 cells/μL or a prior AIDS diagnosis were randomized to receive efavirenz (EFV) or lopinavir/ritonavir (LPV/r) with either zidovudine (ZDV) plus didanosine (ddI) or stavudine (d4T) plus lamivudine (3TC) in an open-label, 2-by-2 factorial study and followed up for the primary outcome of AIDS or death and prespecified secondary outcomes, including CD4 cell count and viral load changes, treatment discontinuation, and grade 4 events.
In total, 1771 persons were randomized and followed up for a median of 24.7 months. AIDS or death occurred in (1) 163 participants assigned EFV and 157 assigned LPV/r (hazard ratio [HR], 1.04 [95% confidence interval {CI}, 0.84-1.30]) and in (2) 170 participants assigned ZDV+ddI and 150 assigned d4T+3TC (HR, 1.15 [95% CI, 0.93-1.44]). HIV RNA levels were lower (P < .001) and CD4 cell counts were greater (P < .01) over follow-up for d4T+3TC versus ZDV+ddI. Rates of potentially life-threatening adverse events and overall treatment discontinuation were similar for d4T+3TC and ZDV+ddI; however, more participants discontinued d4T because of toxicity (12.6%) than other treatments (<5%).
EFV and LPV/r are effective components of first-line ART. The poorer viral and immune responses with ZDV+ddI and the greater toxicity-associated discontinuation rate with d4T+3TC suggest that these treatments be used cautiously as initial therapy.
ClinicalTrials.gov identifier: NCT00342355.</description><subject>Acquired Immunodeficiency Syndrome - complications</subject><subject>Acquired Immunodeficiency Syndrome - drug therapy</subject><subject>Acquired Immunodeficiency Syndrome - immunology</subject><subject>Acquired Immunodeficiency Syndrome - virology</subject><subject>Adult</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Benzoxazines - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>CD4 Lymphocyte Count</subject><subject>Didanosine - adverse effects</subject><subject>Didanosine - therapeutic use</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>HIV - genetics</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Lamivudine - adverse effects</subject><subject>Lamivudine - therapeutic use</subject><subject>Lopinavir</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pyrimidinones - therapeutic use</subject><subject>Ritonavir - therapeutic use</subject><subject>RNA, Viral - blood</subject><subject>South Africa</subject><subject>Stavudine - adverse effects</subject><subject>Stavudine - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Zidovudine - adverse effects</subject><subject>Zidovudine - therapeutic use</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkElOwzAUhi0EgjIdAXkDu1A7djxIbKowVaoAlWFbOR7AqEkqOwXBeTgGZ-BMuC3D5k363v_0fgD2MTrGSLA-KxjHYg30cEF4xhgm66CHUJ5nWEi5BbZjfEYIUcL4JtjKkaQ5K1APfAzgWDWmrf27NfBc6a4NXk3h3TKWbT1TwTePkKaJVV1tmw6O7aNPRYS--Z9mV8q_WHg5fMiGjbO6S3I3NsQ2ca--e4KD4ektTKf6bYAKlqcUlna6ODFPkic5Qss-9r8-Rwvh23a-WHLBa7ULNpyaRrv3k3fA_fnZXXmZja4vhuVglGlCUZexwhrsJK0UF1rgKr3IudRcU2N0UVWOFlIzQow0QpgcOV4JwyU2jCiXM0Z2wNFKV4c2xmDdZBZ8rcLbBKPJwubJyuYEHqzA2byqrfnDfn1NwOEPoKJWUxdUo3385wiRhApBvgH3qIOU</recordid><startdate>20101115</startdate><enddate>20101115</enddate><creator>Ratsela, Andrew</creator><creator>Polis, Michael</creator><creator>Dhlomo, Sibongiseni</creator><creator>Emery, Sean</creator><creator>Grandits, Greg</creator><creator>Khabo, Paul</creator><creator>Khanyile, Thandeka</creator><creator>Komati, Stephanus</creator><creator>Neaton, James D</creator><creator>Naidoo, Lionel Chris David</creator><creator>Magongoa, Daphne</creator><creator>Qolohle, Duma</creator><general>Oxford University Press</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></search><sort><creationdate>20101115</creationdate><title>A Randomized Factorial Trial Comparing 4 Treatment Regimens in Treatment-Naive HIV-Infected Persons with AIDS and/or a CD4 Cell Count <200 Cells/μL in South Africa</title><author>Ratsela, Andrew ; Polis, Michael ; Dhlomo, Sibongiseni ; Emery, Sean ; Grandits, Greg ; Khabo, Paul ; Khanyile, Thandeka ; Komati, Stephanus ; Neaton, James D ; Naidoo, Lionel Chris David ; Magongoa, Daphne ; Qolohle, Duma</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c340t-65ed1f94ba78c81b426779c7c4ddc5bbf459c633d9d88d20f7b8d791d63af2663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Acquired Immunodeficiency Syndrome - complications</topic><topic>Acquired Immunodeficiency Syndrome - drug therapy</topic><topic>Acquired Immunodeficiency Syndrome - immunology</topic><topic>Acquired Immunodeficiency Syndrome - virology</topic><topic>Adult</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Benzoxazines - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>CD4 Lymphocyte Count</topic><topic>Didanosine - adverse effects</topic><topic>Didanosine - therapeutic use</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>HIV - genetics</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Lamivudine - adverse effects</topic><topic>Lamivudine - therapeutic use</topic><topic>Lopinavir</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Pyrimidinones - therapeutic use</topic><topic>Ritonavir - therapeutic use</topic><topic>RNA, Viral - blood</topic><topic>South Africa</topic><topic>Stavudine - adverse effects</topic><topic>Stavudine - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Zidovudine - adverse effects</topic><topic>Zidovudine - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ratsela, Andrew</creatorcontrib><creatorcontrib>Polis, Michael</creatorcontrib><creatorcontrib>Dhlomo, Sibongiseni</creatorcontrib><creatorcontrib>Emery, Sean</creatorcontrib><creatorcontrib>Grandits, Greg</creatorcontrib><creatorcontrib>Khabo, Paul</creatorcontrib><creatorcontrib>Khanyile, Thandeka</creatorcontrib><creatorcontrib>Komati, Stephanus</creatorcontrib><creatorcontrib>Neaton, James D</creatorcontrib><creatorcontrib>Naidoo, Lionel Chris David</creatorcontrib><creatorcontrib>Magongoa, Daphne</creatorcontrib><creatorcontrib>Qolohle, Duma</creatorcontrib><creatorcontrib>Phidisa II Writing Team for Project Phidisa</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><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ratsela, Andrew</au><au>Polis, Michael</au><au>Dhlomo, Sibongiseni</au><au>Emery, Sean</au><au>Grandits, Greg</au><au>Khabo, Paul</au><au>Khanyile, Thandeka</au><au>Komati, Stephanus</au><au>Neaton, James D</au><au>Naidoo, Lionel Chris David</au><au>Magongoa, Daphne</au><au>Qolohle, Duma</au><aucorp>Phidisa II Writing Team for Project Phidisa</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized Factorial Trial Comparing 4 Treatment Regimens in Treatment-Naive HIV-Infected Persons with AIDS and/or a CD4 Cell Count <200 Cells/μL in South Africa</atitle><jtitle>The Journal of infectious diseases</jtitle><addtitle>J Infect Dis</addtitle><date>2010-11-15</date><risdate>2010</risdate><volume>202</volume><issue>10</issue><spage>1529</spage><epage>1537</epage><pages>1529-1537</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><coden>JIDIAQ</coden><abstract>Few randomized trials comparing antiretroviral therapy (ART) regimens have been conducted in resource-limited settings.
In the Republic of South Africa, antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals >14 years old with a CD4 cell count <200 cells/μL or a prior AIDS diagnosis were randomized to receive efavirenz (EFV) or lopinavir/ritonavir (LPV/r) with either zidovudine (ZDV) plus didanosine (ddI) or stavudine (d4T) plus lamivudine (3TC) in an open-label, 2-by-2 factorial study and followed up for the primary outcome of AIDS or death and prespecified secondary outcomes, including CD4 cell count and viral load changes, treatment discontinuation, and grade 4 events.
In total, 1771 persons were randomized and followed up for a median of 24.7 months. AIDS or death occurred in (1) 163 participants assigned EFV and 157 assigned LPV/r (hazard ratio [HR], 1.04 [95% confidence interval {CI}, 0.84-1.30]) and in (2) 170 participants assigned ZDV+ddI and 150 assigned d4T+3TC (HR, 1.15 [95% CI, 0.93-1.44]). HIV RNA levels were lower (P < .001) and CD4 cell counts were greater (P < .01) over follow-up for d4T+3TC versus ZDV+ddI. Rates of potentially life-threatening adverse events and overall treatment discontinuation were similar for d4T+3TC and ZDV+ddI; however, more participants discontinued d4T because of toxicity (12.6%) than other treatments (<5%).
EFV and LPV/r are effective components of first-line ART. The poorer viral and immune responses with ZDV+ddI and the greater toxicity-associated discontinuation rate with d4T+3TC suggest that these treatments be used cautiously as initial therapy.
ClinicalTrials.gov identifier: NCT00342355.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>20942650</pmid><doi>10.1086/656718</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0022-1899 |
| ispartof | The Journal of infectious diseases, 2010-11, Vol.202 (10), p.1529-1537 |
| issn | 0022-1899 1537-6613 |
| language | eng |
| recordid | cdi_crossref_primary_10_1086_656718 |
| source | MEDLINE; Jstor Complete Legacy; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Acquired Immunodeficiency Syndrome - complications Acquired Immunodeficiency Syndrome - drug therapy Acquired Immunodeficiency Syndrome - immunology Acquired Immunodeficiency Syndrome - virology Adult Anti-HIV Agents - adverse effects Anti-HIV Agents - therapeutic use Benzoxazines - therapeutic use Biological and medical sciences CD4 Lymphocyte Count Didanosine - adverse effects Didanosine - therapeutic use Drug Therapy, Combination Female HIV - genetics Human viral diseases Humans Infectious diseases Lamivudine - adverse effects Lamivudine - therapeutic use Lopinavir Male Medical sciences Pyrimidinones - therapeutic use Ritonavir - therapeutic use RNA, Viral - blood South Africa Stavudine - adverse effects Stavudine - therapeutic use Treatment Outcome Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Zidovudine - adverse effects Zidovudine - therapeutic use |
| title | A Randomized Factorial Trial Comparing 4 Treatment Regimens in Treatment-Naive HIV-Infected Persons with AIDS and/or a CD4 Cell Count <200 Cells/μL in South Africa |
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