Clinical toxicity of highly active antiretroviral therapy in a home-based AIDS care program in rural Uganda
We evaluated clinical toxicity in HIV-infected persons receiving antiretroviral therapy (ART) in Uganda. From May 2003 through December 2004, adults with a CD4 cell count < or =250 cells/microL or World Health Organization stage 3/4 HIV disease were prescribed ART. We calculated probabilities for...
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| Veröffentlicht in: | Journal of acquired immune deficiency syndromes (1999) 2007-04, Vol.44 (4), p.456-462 |
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| container_title | Journal of acquired immune deficiency syndromes (1999) |
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| creator | FORNA, Fatu LIECHTY, Cheryl A SOLBERG, Peter ASIIMWE, Fred WERE, Willy MERMIN, Jonathan BEHUMBIIZE, Prosper TONG, Tony BROOKS, John T WEIDLE, Paul J |
| description | We evaluated clinical toxicity in HIV-infected persons receiving antiretroviral therapy (ART) in Uganda.
From May 2003 through December 2004, adults with a CD4 cell count < or =250 cells/microL or World Health Organization stage 3/4 HIV disease were prescribed ART. We calculated probabilities for time to toxicity and single-drug substitution as well as multivariate-adjusted hazard ratios for development of toxicity.
ART (stavudine plus lamivudine with nevirapine [96%] or efavirenz [4%]) was prescribed for 1029 adults, contributing 11,268 person-months of observation. Toxicities developed in 543 instances in 411 (40%) patients (incidence rate = 4.47/100 person-months): 36% peripheral neuropathy (9% severe); 6% rash (2% severe); 2% hypersensitivity reaction; < or =0.5% acute hepatitis, anemia, acute pancreatitis, or lactic acidosis; and 13% other. Probabilities of remaining free from any toxicity at 6, 12, and 18 months were 0.76, 0.59, and 0.47 and from any severe toxicity at 6, 12, and 18 months were 0.92, 0.86, and 0.85, respectively. For 217 patients (21%), 222 single-drug substitutions were made, mostly because of peripheral neuropathy or rash.
Clinical toxicities were common, but no patients discontinued ART because of toxicity. The most common toxicities, peripheral neuropathy and rash, were managed with single-drug substitutions. In resource-limited settings, toxicity from ART regimens containing stavudine or nevirapine is manageable but more tolerable regimens are needed. |
| doi_str_mv | 10.1097/QAI.0b013e318033ffa1 |
| format | Article |
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From May 2003 through December 2004, adults with a CD4 cell count < or =250 cells/microL or World Health Organization stage 3/4 HIV disease were prescribed ART. We calculated probabilities for time to toxicity and single-drug substitution as well as multivariate-adjusted hazard ratios for development of toxicity.
ART (stavudine plus lamivudine with nevirapine [96%] or efavirenz [4%]) was prescribed for 1029 adults, contributing 11,268 person-months of observation. Toxicities developed in 543 instances in 411 (40%) patients (incidence rate = 4.47/100 person-months): 36% peripheral neuropathy (9% severe); 6% rash (2% severe); 2% hypersensitivity reaction; < or =0.5% acute hepatitis, anemia, acute pancreatitis, or lactic acidosis; and 13% other. Probabilities of remaining free from any toxicity at 6, 12, and 18 months were 0.76, 0.59, and 0.47 and from any severe toxicity at 6, 12, and 18 months were 0.92, 0.86, and 0.85, respectively. For 217 patients (21%), 222 single-drug substitutions were made, mostly because of peripheral neuropathy or rash.
Clinical toxicities were common, but no patients discontinued ART because of toxicity. The most common toxicities, peripheral neuropathy and rash, were managed with single-drug substitutions. In resource-limited settings, toxicity from ART regimens containing stavudine or nevirapine is manageable but more tolerable regimens are needed.</description><identifier>ISSN: 1525-4135</identifier><identifier>EISSN: 1944-7884</identifier><identifier>DOI: 10.1097/QAI.0b013e318033ffa1</identifier><identifier>PMID: 17279048</identifier><identifier>CODEN: JDSRET</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Acquired Immunodeficiency Syndrome - drug therapy ; Acquired Immunodeficiency Syndrome - immunology ; Adult ; Aged ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Antiretroviral drugs ; Antiretroviral Therapy, Highly Active - adverse effects ; Antiretroviral Therapy, Highly Active - statistics & numerical data ; Benzoxazines - adverse effects ; Benzoxazines - therapeutic use ; Biological and medical sciences ; CD4 Lymphocyte Count ; Chemical and Drug Induced Liver Injury - etiology ; Drug therapy ; Exanthema - chemically induced ; Female ; Fundamental and applied biological sciences. Psychology ; HIV ; HIV Infections - drug therapy ; HIV Infections - immunology ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Infectious diseases ; Lamivudine - adverse effects ; Lamivudine - therapeutic use ; Male ; Medical sciences ; Microbiology ; Middle Aged ; Miscellaneous ; Multivariate Analysis ; Nevirapine - adverse effects ; Nevirapine - therapeutic use ; Pancreatitis - chemically induced ; Peripheral Nervous System Diseases - chemically induced ; Proportional Hazards Models ; Rural Health - statistics & numerical data ; Stavudine - adverse effects ; Stavudine - therapeutic use ; Survival Analysis ; Toxicity ; Uganda ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Virology ; Wellness programs</subject><ispartof>Journal of acquired immune deficiency syndromes (1999), 2007-04, Vol.44 (4), p.456-462</ispartof><rights>2007 INIST-CNRS</rights><rights>Copyright Lippincott Williams & Wilkins Apr 1, 2007</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c408t-c878965b5d1961ffd7f556460f6db5de1e2d8b56c9acf8df4675566e8273e1d3</citedby><cites>FETCH-LOGICAL-c408t-c878965b5d1961ffd7f556460f6db5de1e2d8b56c9acf8df4675566e8273e1d3</cites></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=18611658$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17279048$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>FORNA, Fatu</creatorcontrib><creatorcontrib>LIECHTY, Cheryl A</creatorcontrib><creatorcontrib>SOLBERG, Peter</creatorcontrib><creatorcontrib>ASIIMWE, Fred</creatorcontrib><creatorcontrib>WERE, Willy</creatorcontrib><creatorcontrib>MERMIN, Jonathan</creatorcontrib><creatorcontrib>BEHUMBIIZE, Prosper</creatorcontrib><creatorcontrib>TONG, Tony</creatorcontrib><creatorcontrib>BROOKS, John T</creatorcontrib><creatorcontrib>WEIDLE, Paul J</creatorcontrib><title>Clinical toxicity of highly active antiretroviral therapy in a home-based AIDS care program in rural Uganda</title><title>Journal of acquired immune deficiency syndromes (1999)</title><addtitle>J Acquir Immune Defic Syndr</addtitle><description>We evaluated clinical toxicity in HIV-infected persons receiving antiretroviral therapy (ART) in Uganda.
From May 2003 through December 2004, adults with a CD4 cell count < or =250 cells/microL or World Health Organization stage 3/4 HIV disease were prescribed ART. We calculated probabilities for time to toxicity and single-drug substitution as well as multivariate-adjusted hazard ratios for development of toxicity.
ART (stavudine plus lamivudine with nevirapine [96%] or efavirenz [4%]) was prescribed for 1029 adults, contributing 11,268 person-months of observation. Toxicities developed in 543 instances in 411 (40%) patients (incidence rate = 4.47/100 person-months): 36% peripheral neuropathy (9% severe); 6% rash (2% severe); 2% hypersensitivity reaction; < or =0.5% acute hepatitis, anemia, acute pancreatitis, or lactic acidosis; and 13% other. Probabilities of remaining free from any toxicity at 6, 12, and 18 months were 0.76, 0.59, and 0.47 and from any severe toxicity at 6, 12, and 18 months were 0.92, 0.86, and 0.85, respectively. For 217 patients (21%), 222 single-drug substitutions were made, mostly because of peripheral neuropathy or rash.
Clinical toxicities were common, but no patients discontinued ART because of toxicity. The most common toxicities, peripheral neuropathy and rash, were managed with single-drug substitutions. In resource-limited settings, toxicity from ART regimens containing stavudine or nevirapine is manageable but more tolerable regimens are needed.</description><subject>Acquired Immunodeficiency Syndrome - drug therapy</subject><subject>Acquired Immunodeficiency Syndrome - immunology</subject><subject>Adult</subject><subject>Aged</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral drugs</subject><subject>Antiretroviral Therapy, Highly Active - adverse effects</subject><subject>Antiretroviral Therapy, Highly Active - statistics & numerical data</subject><subject>Benzoxazines - adverse effects</subject><subject>Benzoxazines - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>CD4 Lymphocyte Count</subject><subject>Chemical and Drug Induced Liver Injury - etiology</subject><subject>Drug therapy</subject><subject>Exanthema - chemically induced</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - immunology</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Lamivudine - adverse effects</subject><subject>Lamivudine - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Multivariate Analysis</subject><subject>Nevirapine - adverse effects</subject><subject>Nevirapine - therapeutic use</subject><subject>Pancreatitis - chemically induced</subject><subject>Peripheral Nervous System Diseases - chemically induced</subject><subject>Proportional Hazards Models</subject><subject>Rural Health - statistics & numerical data</subject><subject>Stavudine - adverse effects</subject><subject>Stavudine - therapeutic use</subject><subject>Survival Analysis</subject><subject>Toxicity</subject><subject>Uganda</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Virology</subject><subject>Wellness programs</subject><issn>1525-4135</issn><issn>1944-7884</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkNtKAzEURYMo3v9AJAg-Ts2ZXOex1FtBEFGfh0wubWo7U5NpsX9vioWCTwnJ2vscFkJXQAZAKnn3NhwPSEOAOgqKUOq9hgN0ChVjhVSKHeY7L3nBgPITdJbSjBAQjFXH6ARkKSvC1Cn6Gs1DG4ye4777CSb0G9x5PA2T6XyDtenD2mHd9iG6PnbrELfg1EW93ODQYo2n3cIVjU7O4uH4_h0bHR1exm4S9WJLxNU28jnRrdUX6MjreXKXu_McfTw-fIyei5fXp_Fo-FIYRlRfGCVVJXjDLVQCvLfScy6YIF7Y_OjAlVY1XJhKG6-sZ0Lmf-FUKakDS8_RzV9tXuN75VJfz7pVbPPEuqRUMC45ZIj9QSZ2KUXn62UMCx03NZB667fOfuv_fnPsete9ahbO7kM7oRm43QE6Zas-6taEtOeUABBc0V-HsoUA</recordid><startdate>20070401</startdate><enddate>20070401</enddate><creator>FORNA, Fatu</creator><creator>LIECHTY, Cheryl A</creator><creator>SOLBERG, Peter</creator><creator>ASIIMWE, Fred</creator><creator>WERE, Willy</creator><creator>MERMIN, Jonathan</creator><creator>BEHUMBIIZE, Prosper</creator><creator>TONG, Tony</creator><creator>BROOKS, John T</creator><creator>WEIDLE, Paul J</creator><general>Lippincott Williams & Wilkins</general><general>Lippincott Williams & Wilkins Ovid Technologies</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>7T2</scope><scope>7T5</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope></search><sort><creationdate>20070401</creationdate><title>Clinical toxicity of highly active antiretroviral therapy in a home-based AIDS care program in rural Uganda</title><author>FORNA, Fatu ; LIECHTY, Cheryl A ; SOLBERG, Peter ; ASIIMWE, Fred ; WERE, Willy ; MERMIN, Jonathan ; BEHUMBIIZE, Prosper ; TONG, Tony ; BROOKS, John T ; WEIDLE, Paul J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c408t-c878965b5d1961ffd7f556460f6db5de1e2d8b56c9acf8df4675566e8273e1d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Acquired Immunodeficiency Syndrome - drug therapy</topic><topic>Acquired Immunodeficiency Syndrome - immunology</topic><topic>Adult</topic><topic>Aged</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral drugs</topic><topic>Antiretroviral Therapy, Highly Active - adverse effects</topic><topic>Antiretroviral Therapy, Highly Active - statistics & numerical data</topic><topic>Benzoxazines - adverse effects</topic><topic>Benzoxazines - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>CD4 Lymphocyte Count</topic><topic>Chemical and Drug Induced Liver Injury - etiology</topic><topic>Drug therapy</topic><topic>Exanthema - chemically induced</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - immunology</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Lamivudine - adverse effects</topic><topic>Lamivudine - therapeutic use</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Multivariate Analysis</topic><topic>Nevirapine - adverse effects</topic><topic>Nevirapine - therapeutic use</topic><topic>Pancreatitis - chemically induced</topic><topic>Peripheral Nervous System Diseases - chemically induced</topic><topic>Proportional Hazards Models</topic><topic>Rural Health - statistics & numerical data</topic><topic>Stavudine - adverse effects</topic><topic>Stavudine - therapeutic use</topic><topic>Survival Analysis</topic><topic>Toxicity</topic><topic>Uganda</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Virology</topic><topic>Wellness programs</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>FORNA, Fatu</creatorcontrib><creatorcontrib>LIECHTY, Cheryl A</creatorcontrib><creatorcontrib>SOLBERG, Peter</creatorcontrib><creatorcontrib>ASIIMWE, Fred</creatorcontrib><creatorcontrib>WERE, Willy</creatorcontrib><creatorcontrib>MERMIN, Jonathan</creatorcontrib><creatorcontrib>BEHUMBIIZE, Prosper</creatorcontrib><creatorcontrib>TONG, Tony</creatorcontrib><creatorcontrib>BROOKS, John T</creatorcontrib><creatorcontrib>WEIDLE, Paul J</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>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>FORNA, Fatu</au><au>LIECHTY, Cheryl A</au><au>SOLBERG, Peter</au><au>ASIIMWE, Fred</au><au>WERE, Willy</au><au>MERMIN, Jonathan</au><au>BEHUMBIIZE, Prosper</au><au>TONG, Tony</au><au>BROOKS, John T</au><au>WEIDLE, Paul J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical toxicity of highly active antiretroviral therapy in a home-based AIDS care program in rural Uganda</atitle><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle><addtitle>J Acquir Immune Defic Syndr</addtitle><date>2007-04-01</date><risdate>2007</risdate><volume>44</volume><issue>4</issue><spage>456</spage><epage>462</epage><pages>456-462</pages><issn>1525-4135</issn><eissn>1944-7884</eissn><coden>JDSRET</coden><abstract>We evaluated clinical toxicity in HIV-infected persons receiving antiretroviral therapy (ART) in Uganda.
From May 2003 through December 2004, adults with a CD4 cell count < or =250 cells/microL or World Health Organization stage 3/4 HIV disease were prescribed ART. We calculated probabilities for time to toxicity and single-drug substitution as well as multivariate-adjusted hazard ratios for development of toxicity.
ART (stavudine plus lamivudine with nevirapine [96%] or efavirenz [4%]) was prescribed for 1029 adults, contributing 11,268 person-months of observation. Toxicities developed in 543 instances in 411 (40%) patients (incidence rate = 4.47/100 person-months): 36% peripheral neuropathy (9% severe); 6% rash (2% severe); 2% hypersensitivity reaction; < or =0.5% acute hepatitis, anemia, acute pancreatitis, or lactic acidosis; and 13% other. Probabilities of remaining free from any toxicity at 6, 12, and 18 months were 0.76, 0.59, and 0.47 and from any severe toxicity at 6, 12, and 18 months were 0.92, 0.86, and 0.85, respectively. For 217 patients (21%), 222 single-drug substitutions were made, mostly because of peripheral neuropathy or rash.
Clinical toxicities were common, but no patients discontinued ART because of toxicity. The most common toxicities, peripheral neuropathy and rash, were managed with single-drug substitutions. In resource-limited settings, toxicity from ART regimens containing stavudine or nevirapine is manageable but more tolerable regimens are needed.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>17279048</pmid><doi>10.1097/QAI.0b013e318033ffa1</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of acquired immune deficiency syndromes (1999), 2007-04, Vol.44 (4), p.456-462 |
| issn | 1525-4135 1944-7884 |
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| subjects | Acquired Immunodeficiency Syndrome - drug therapy Acquired Immunodeficiency Syndrome - immunology Adult Aged Anti-HIV Agents - adverse effects Anti-HIV Agents - therapeutic use Antiretroviral drugs Antiretroviral Therapy, Highly Active - adverse effects Antiretroviral Therapy, Highly Active - statistics & numerical data Benzoxazines - adverse effects Benzoxazines - therapeutic use Biological and medical sciences CD4 Lymphocyte Count Chemical and Drug Induced Liver Injury - etiology Drug therapy Exanthema - chemically induced Female Fundamental and applied biological sciences. Psychology HIV HIV Infections - drug therapy HIV Infections - immunology Human immunodeficiency virus Human viral diseases Humans Infectious diseases Lamivudine - adverse effects Lamivudine - therapeutic use Male Medical sciences Microbiology Middle Aged Miscellaneous Multivariate Analysis Nevirapine - adverse effects Nevirapine - therapeutic use Pancreatitis - chemically induced Peripheral Nervous System Diseases - chemically induced Proportional Hazards Models Rural Health - statistics & numerical data Stavudine - adverse effects Stavudine - therapeutic use Survival Analysis Toxicity Uganda Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Virology Wellness programs |
| title | Clinical toxicity of highly active antiretroviral therapy in a home-based AIDS care program in rural Uganda |
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