Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study

The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1...

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Veröffentlicht in:PloS one 2009-04, Vol.4 (4), p.e5272-e5272
Hauptverfasser: Lingappa, Jairam R, Kahle, Erin, Mugo, Nelly, Mujugira, Andrew, Magaret, Amalia, Baeten, Jared, Bukusi, Elizabeth A, Cohen, Craig R, Katabira, Elly, Ronald, Allan, Kiarie, James, Farquhar, Carey, Stewart, Grace John, Makhema, Joseph, Essex, M, Were, Edwin, Fife, Kenneth, Debruyn, Guy, Gray, Glenda, McIntyre, James, Manongi, Rachel, Kapiga, Saidi, Coetzee, David, Allen, Susan, Inambao, Mubiana, Kayitenkore, Kayitesi, Karita, Etienne, Kanweka, William, Delany, Sinead, Rees, Helen, Vwalika, Bellington, Coombs, Robert W, Morrow, Rhoda, Whittington, William, Corey, Lawrence, Wald, Anna, Celum, Connie
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container_issue 4
container_start_page e5272
container_title PloS one
container_volume 4
creator Lingappa, Jairam R
Kahle, Erin
Mugo, Nelly
Mujugira, Andrew
Magaret, Amalia
Baeten, Jared
Bukusi, Elizabeth A
Cohen, Craig R
Katabira, Elly
Ronald, Allan
Kiarie, James
Farquhar, Carey
Stewart, Grace John
Makhema, Joseph
Essex, M
Were, Edwin
Fife, Kenneth
Debruyn, Guy
Gray, Glenda
McIntyre, James
Manongi, Rachel
Kapiga, Saidi
Coetzee, David
Allen, Susan
Inambao, Mubiana
Kayitenkore, Kayitesi
Karita, Etienne
Kanweka, William
Delany, Sinead
Rees, Helen
Vwalika, Bellington
Coombs, Robert W
Morrow, Rhoda
Whittington, William
Corey, Lawrence
Wald, Anna
Celum, Connie
description The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort. HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed. Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (
doi_str_mv 10.1371/journal.pone.0005272
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We describe the baseline characteristics of this cohort. HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count &gt;or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed. Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (&lt;5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p&lt;0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and &gt;500 relative to &lt;350, respectively, p&lt;0.001). The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission. ClinicalTrials.gov NCT00194519.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0005272</identifier><identifier>PMID: 19404392</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acquired immune deficiency syndrome ; Acyclovir ; Acyclovir - administration &amp; dosage ; Adult ; Africa ; AIDS ; Antiretroviral agents ; Antiretroviral therapy ; Antiviral Agents - therapeutic use ; Behavior ; Cancer ; CD4 antigen ; CD4 Lymphocyte Count ; Chlamydia ; Cohort Studies ; Counseling ; Couples ; Demographics ; Disease transmission ; Epidemiology ; Female ; Follow-Up Studies ; Gender ; Gynecology ; Health aspects ; Health risks ; Herpes Genitalis - drug therapy ; Herpesvirus 2, Human ; Heterosexuality ; Highly active antiretroviral therapy ; HIV ; HIV (Viruses) ; HIV Infections - prevention &amp; control ; HIV Infections - transmission ; HIV-1 - genetics ; Hospitals ; Human immunodeficiency virus ; Humans ; Husband and wife ; Infectious diseases ; Infectious Diseases/HIV Infection and AIDS ; Infectious Diseases/Sexually Transmitted Diseases ; Laboratories ; Male ; Medicine ; Obstetrics ; Parasitic diseases ; Product development ; Public health ; Public Health and Epidemiology/Infectious Diseases ; Public Health and Epidemiology/Preventive Medicine ; Recruitment ; Reproductive health ; Ribonucleic acid ; RNA ; RNA, Viral - blood ; Sexual Partners ; Sexually Transmitted Diseases ; STD ; Studies</subject><ispartof>PloS one, 2009-04, Vol.4 (4), p.e5272-e5272</ispartof><rights>COPYRIGHT 2009 Public Library of Science</rights><rights>2009 Lingappa et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Lingappa et al. 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c690t-140f26462e320e28013e2c14ff07c1643d9de738acf66ea5c3279a3670e30c623</citedby><cites>FETCH-LOGICAL-c690t-140f26462e320e28013e2c14ff07c1643d9de738acf66ea5c3279a3670e30c623</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671170/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671170/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19404392$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lingappa, Jairam R</creatorcontrib><creatorcontrib>Kahle, Erin</creatorcontrib><creatorcontrib>Mugo, Nelly</creatorcontrib><creatorcontrib>Mujugira, Andrew</creatorcontrib><creatorcontrib>Magaret, Amalia</creatorcontrib><creatorcontrib>Baeten, Jared</creatorcontrib><creatorcontrib>Bukusi, Elizabeth A</creatorcontrib><creatorcontrib>Cohen, Craig R</creatorcontrib><creatorcontrib>Katabira, Elly</creatorcontrib><creatorcontrib>Ronald, Allan</creatorcontrib><creatorcontrib>Kiarie, James</creatorcontrib><creatorcontrib>Farquhar, Carey</creatorcontrib><creatorcontrib>Stewart, Grace John</creatorcontrib><creatorcontrib>Makhema, Joseph</creatorcontrib><creatorcontrib>Essex, M</creatorcontrib><creatorcontrib>Were, Edwin</creatorcontrib><creatorcontrib>Fife, Kenneth</creatorcontrib><creatorcontrib>Debruyn, Guy</creatorcontrib><creatorcontrib>Gray, Glenda</creatorcontrib><creatorcontrib>McIntyre, James</creatorcontrib><creatorcontrib>Manongi, Rachel</creatorcontrib><creatorcontrib>Kapiga, Saidi</creatorcontrib><creatorcontrib>Coetzee, David</creatorcontrib><creatorcontrib>Allen, Susan</creatorcontrib><creatorcontrib>Inambao, Mubiana</creatorcontrib><creatorcontrib>Kayitenkore, Kayitesi</creatorcontrib><creatorcontrib>Karita, Etienne</creatorcontrib><creatorcontrib>Kanweka, William</creatorcontrib><creatorcontrib>Delany, Sinead</creatorcontrib><creatorcontrib>Rees, Helen</creatorcontrib><creatorcontrib>Vwalika, Bellington</creatorcontrib><creatorcontrib>Coombs, Robert W</creatorcontrib><creatorcontrib>Morrow, Rhoda</creatorcontrib><creatorcontrib>Whittington, William</creatorcontrib><creatorcontrib>Corey, Lawrence</creatorcontrib><creatorcontrib>Wald, Anna</creatorcontrib><creatorcontrib>Celum, Connie</creatorcontrib><creatorcontrib>Partners HSV-2/HIV-1 Transmission Study Team</creatorcontrib><creatorcontrib>for the Partners HSV-2/HIV-1 Transmission Study Team</creatorcontrib><title>Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort. HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count &gt;or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed. Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (&lt;5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p&lt;0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and &gt;500 relative to &lt;350, respectively, p&lt;0.001). The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission. ClinicalTrials.gov NCT00194519.</description><subject>Acquired immune deficiency syndrome</subject><subject>Acyclovir</subject><subject>Acyclovir - administration &amp; dosage</subject><subject>Adult</subject><subject>Africa</subject><subject>AIDS</subject><subject>Antiretroviral agents</subject><subject>Antiretroviral therapy</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Behavior</subject><subject>Cancer</subject><subject>CD4 antigen</subject><subject>CD4 Lymphocyte Count</subject><subject>Chlamydia</subject><subject>Cohort Studies</subject><subject>Counseling</subject><subject>Couples</subject><subject>Demographics</subject><subject>Disease transmission</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gender</subject><subject>Gynecology</subject><subject>Health aspects</subject><subject>Health risks</subject><subject>Herpes Genitalis - drug therapy</subject><subject>Herpesvirus 2, Human</subject><subject>Heterosexuality</subject><subject>Highly active antiretroviral therapy</subject><subject>HIV</subject><subject>HIV (Viruses)</subject><subject>HIV Infections - prevention &amp; control</subject><subject>HIV Infections - transmission</subject><subject>HIV-1 - genetics</subject><subject>Hospitals</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Husband and wife</subject><subject>Infectious diseases</subject><subject>Infectious Diseases/HIV Infection and AIDS</subject><subject>Infectious Diseases/Sexually Transmitted Diseases</subject><subject>Laboratories</subject><subject>Male</subject><subject>Medicine</subject><subject>Obstetrics</subject><subject>Parasitic diseases</subject><subject>Product development</subject><subject>Public health</subject><subject>Public Health and Epidemiology/Infectious Diseases</subject><subject>Public Health and Epidemiology/Preventive Medicine</subject><subject>Recruitment</subject><subject>Reproductive health</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>RNA, Viral - blood</subject><subject>Sexual Partners</subject><subject>Sexually Transmitted 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of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study</title><author>Lingappa, Jairam R ; Kahle, Erin ; Mugo, Nelly ; Mujugira, Andrew ; Magaret, Amalia ; Baeten, Jared ; Bukusi, Elizabeth A ; Cohen, Craig R ; Katabira, Elly ; Ronald, Allan ; Kiarie, James ; Farquhar, Carey ; Stewart, Grace John ; Makhema, Joseph ; Essex, M ; Were, Edwin ; Fife, Kenneth ; Debruyn, Guy ; Gray, Glenda ; McIntyre, James ; Manongi, Rachel ; Kapiga, Saidi ; Coetzee, David ; Allen, Susan ; Inambao, Mubiana ; Kayitenkore, Kayitesi ; Karita, Etienne ; Kanweka, William ; Delany, Sinead ; Rees, Helen ; Vwalika, Bellington ; Coombs, Robert W ; Morrow, Rhoda ; Whittington, William ; Corey, Lawrence ; Wald, Anna ; Celum, Connie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c690t-140f26462e320e28013e2c14ff07c1643d9de738acf66ea5c3279a3670e30c623</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Acyclovir</topic><topic>Acyclovir - administration &amp; dosage</topic><topic>Adult</topic><topic>Africa</topic><topic>AIDS</topic><topic>Antiretroviral agents</topic><topic>Antiretroviral therapy</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Behavior</topic><topic>Cancer</topic><topic>CD4 antigen</topic><topic>CD4 Lymphocyte Count</topic><topic>Chlamydia</topic><topic>Cohort Studies</topic><topic>Counseling</topic><topic>Couples</topic><topic>Demographics</topic><topic>Disease transmission</topic><topic>Epidemiology</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gender</topic><topic>Gynecology</topic><topic>Health aspects</topic><topic>Health risks</topic><topic>Herpes Genitalis - drug therapy</topic><topic>Herpesvirus 2, Human</topic><topic>Heterosexuality</topic><topic>Highly active antiretroviral therapy</topic><topic>HIV</topic><topic>HIV (Viruses)</topic><topic>HIV Infections - prevention &amp; control</topic><topic>HIV Infections - transmission</topic><topic>HIV-1 - genetics</topic><topic>Hospitals</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Husband and wife</topic><topic>Infectious diseases</topic><topic>Infectious Diseases/HIV Infection and AIDS</topic><topic>Infectious Diseases/Sexually Transmitted Diseases</topic><topic>Laboratories</topic><topic>Male</topic><topic>Medicine</topic><topic>Obstetrics</topic><topic>Parasitic diseases</topic><topic>Product development</topic><topic>Public health</topic><topic>Public Health and Epidemiology/Infectious Diseases</topic><topic>Public Health and Epidemiology/Preventive Medicine</topic><topic>Recruitment</topic><topic>Reproductive health</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>RNA, Viral - blood</topic><topic>Sexual Partners</topic><topic>Sexually Transmitted Diseases</topic><topic>STD</topic><topic>Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lingappa, Jairam R</creatorcontrib><creatorcontrib>Kahle, Erin</creatorcontrib><creatorcontrib>Mugo, Nelly</creatorcontrib><creatorcontrib>Mujugira, Andrew</creatorcontrib><creatorcontrib>Magaret, Amalia</creatorcontrib><creatorcontrib>Baeten, Jared</creatorcontrib><creatorcontrib>Bukusi, Elizabeth A</creatorcontrib><creatorcontrib>Cohen, Craig R</creatorcontrib><creatorcontrib>Katabira, Elly</creatorcontrib><creatorcontrib>Ronald, Allan</creatorcontrib><creatorcontrib>Kiarie, James</creatorcontrib><creatorcontrib>Farquhar, Carey</creatorcontrib><creatorcontrib>Stewart, Grace John</creatorcontrib><creatorcontrib>Makhema, Joseph</creatorcontrib><creatorcontrib>Essex, M</creatorcontrib><creatorcontrib>Were, Edwin</creatorcontrib><creatorcontrib>Fife, Kenneth</creatorcontrib><creatorcontrib>Debruyn, Guy</creatorcontrib><creatorcontrib>Gray, Glenda</creatorcontrib><creatorcontrib>McIntyre, James</creatorcontrib><creatorcontrib>Manongi, Rachel</creatorcontrib><creatorcontrib>Kapiga, Saidi</creatorcontrib><creatorcontrib>Coetzee, David</creatorcontrib><creatorcontrib>Allen, Susan</creatorcontrib><creatorcontrib>Inambao, Mubiana</creatorcontrib><creatorcontrib>Kayitenkore, Kayitesi</creatorcontrib><creatorcontrib>Karita, Etienne</creatorcontrib><creatorcontrib>Kanweka, William</creatorcontrib><creatorcontrib>Delany, Sinead</creatorcontrib><creatorcontrib>Rees, Helen</creatorcontrib><creatorcontrib>Vwalika, Bellington</creatorcontrib><creatorcontrib>Coombs, Robert W</creatorcontrib><creatorcontrib>Morrow, Rhoda</creatorcontrib><creatorcontrib>Whittington, William</creatorcontrib><creatorcontrib>Corey, Lawrence</creatorcontrib><creatorcontrib>Wald, Anna</creatorcontrib><creatorcontrib>Celum, Connie</creatorcontrib><creatorcontrib>Partners HSV-2/HIV-1 Transmission Study Team</creatorcontrib><creatorcontrib>for the Partners HSV-2/HIV-1 Transmission Study Team</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing &amp; Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological &amp; Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science &amp; Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies &amp; Aerospace Collection</collection><collection>Agricultural &amp; Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research 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Database</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Advanced Technologies &amp; Aerospace Database</collection><collection>ProQuest Advanced Technologies &amp; Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lingappa, Jairam R</au><au>Kahle, Erin</au><au>Mugo, Nelly</au><au>Mujugira, Andrew</au><au>Magaret, Amalia</au><au>Baeten, Jared</au><au>Bukusi, Elizabeth A</au><au>Cohen, Craig R</au><au>Katabira, Elly</au><au>Ronald, Allan</au><au>Kiarie, James</au><au>Farquhar, Carey</au><au>Stewart, Grace John</au><au>Makhema, Joseph</au><au>Essex, M</au><au>Were, Edwin</au><au>Fife, Kenneth</au><au>Debruyn, Guy</au><au>Gray, Glenda</au><au>McIntyre, James</au><au>Manongi, Rachel</au><au>Kapiga, Saidi</au><au>Coetzee, David</au><au>Allen, Susan</au><au>Inambao, Mubiana</au><au>Kayitenkore, Kayitesi</au><au>Karita, Etienne</au><au>Kanweka, William</au><au>Delany, Sinead</au><au>Rees, Helen</au><au>Vwalika, Bellington</au><au>Coombs, Robert W</au><au>Morrow, Rhoda</au><au>Whittington, William</au><au>Corey, Lawrence</au><au>Wald, Anna</au><au>Celum, Connie</au><aucorp>Partners HSV-2/HIV-1 Transmission Study Team</aucorp><aucorp>for the Partners HSV-2/HIV-1 Transmission Study Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2009-04-30</date><risdate>2009</risdate><volume>4</volume><issue>4</issue><spage>e5272</spage><epage>e5272</epage><pages>e5272-e5272</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort. HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count &gt;or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed. Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (&lt;5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p&lt;0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and &gt;500 relative to &lt;350, respectively, p&lt;0.001). The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission. ClinicalTrials.gov NCT00194519.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>19404392</pmid><doi>10.1371/journal.pone.0005272</doi><tpages>e5272</tpages><oa>free_for_read</oa></addata></record>
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subjects Acquired immune deficiency syndrome
Acyclovir
Acyclovir - administration & dosage
Adult
Africa
AIDS
Antiretroviral agents
Antiretroviral therapy
Antiviral Agents - therapeutic use
Behavior
Cancer
CD4 antigen
CD4 Lymphocyte Count
Chlamydia
Cohort Studies
Counseling
Couples
Demographics
Disease transmission
Epidemiology
Female
Follow-Up Studies
Gender
Gynecology
Health aspects
Health risks
Herpes Genitalis - drug therapy
Herpesvirus 2, Human
Heterosexuality
Highly active antiretroviral therapy
HIV
HIV (Viruses)
HIV Infections - prevention & control
HIV Infections - transmission
HIV-1 - genetics
Hospitals
Human immunodeficiency virus
Humans
Husband and wife
Infectious diseases
Infectious Diseases/HIV Infection and AIDS
Infectious Diseases/Sexually Transmitted Diseases
Laboratories
Male
Medicine
Obstetrics
Parasitic diseases
Product development
Public health
Public Health and Epidemiology/Infectious Diseases
Public Health and Epidemiology/Preventive Medicine
Recruitment
Reproductive health
Ribonucleic acid
RNA
RNA, Viral - blood
Sexual Partners
Sexually Transmitted Diseases
STD
Studies
title Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study
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