Passive Immunotherapy in AIDS: A Double-Blind Randomized Study Based on Transfusions of Plasma Rich in Anti-Human Immunodeficiency Virus 1 Antibodies vs. Transfusions of Seronegative Plasma
A randomized double-blind controlled trial was conducted to determine the efficacy of passive immunotherapy in the treatment of symptomatic human immunodeficiency virus (HIV) infection. This trial included 86 symptomatic patients randomized to receive plasma rich in anti-HIV-1 antibody or standard s...
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| Veröffentlicht in: | Proceedings of the National Academy of Sciences - PNAS 1995-02, Vol.92 (4), p.1195-1199 |
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| creator | Vittecoq, D. Chevret, S. Morand-Joubert, L. Heshmati, F. Audat, F. Bary, M. Dusautoir, T. Bismuth, A. Viard, J. P. Barre-Sinoussi, F. Bach, J. F. Lefrere, J. J. |
| description | A randomized double-blind controlled trial was conducted to determine the efficacy of passive immunotherapy in the treatment of symptomatic human immunodeficiency virus (HIV) infection. This trial included 86 symptomatic patients randomized to receive plasma rich in anti-HIV-1 antibody or standard seronegative plasma. Each patient in both groups received a 300-ml infusion every 14 days over a 1-year period, and every 28 days thereafter, in addition to zidovudine and other conventional prophylactic treatments. Plasma donors were selected among symptomless seropositive individuals with a CD4 lymphocyte count ≥400 x 106cells per liter, a negative p24 antigen assay, and a high concentration of anti-p24 antibody. The plasmas were heat-inactivated before infusion. During the study period (day 28-day 365) scheduled by the protocol, clinical benefit from passive immunotherapy was observed in delaying the appearance of the first AIDS-defining event (P < 0.009) and reducing the cumulative incidence of such events, which was estimated 3-fold higher in the control group compared to the treatment group. Seven deaths occurred in the treatment group vs. 11 in the control group (P = 0.27). A total of 47 patients died or exhibited new AIDS-defining events, 18 in the treatment group and 29 in the control group (P = 0.009). No clinical benefit was observed after the 1-year period with infusions performed every 4 weeks. These results indicate a favorable effect of passive immunotherapy on the evolution of advanced AIDS. |
| doi_str_mv | 10.1073/pnas.92.4.1195 |
| format | Article |
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P. ; Barre-Sinoussi, F. ; Bach, J. F. ; Lefrere, J. J.</creator><creatorcontrib>Vittecoq, D. ; Chevret, S. ; Morand-Joubert, L. ; Heshmati, F. ; Audat, F. ; Bary, M. ; Dusautoir, T. ; Bismuth, A. ; Viard, J. P. ; Barre-Sinoussi, F. ; Bach, J. F. ; Lefrere, J. J.</creatorcontrib><description>A randomized double-blind controlled trial was conducted to determine the efficacy of passive immunotherapy in the treatment of symptomatic human immunodeficiency virus (HIV) infection. This trial included 86 symptomatic patients randomized to receive plasma rich in anti-HIV-1 antibody or standard seronegative plasma. Each patient in both groups received a 300-ml infusion every 14 days over a 1-year period, and every 28 days thereafter, in addition to zidovudine and other conventional prophylactic treatments. Plasma donors were selected among symptomless seropositive individuals with a CD4 lymphocyte count ≥400 x 106cells per liter, a negative p24 antigen assay, and a high concentration of anti-p24 antibody. The plasmas were heat-inactivated before infusion. During the study period (day 28-day 365) scheduled by the protocol, clinical benefit from passive immunotherapy was observed in delaying the appearance of the first AIDS-defining event (P < 0.009) and reducing the cumulative incidence of such events, which was estimated 3-fold higher in the control group compared to the treatment group. Seven deaths occurred in the treatment group vs. 11 in the control group (P = 0.27). A total of 47 patients died or exhibited new AIDS-defining events, 18 in the treatment group and 29 in the control group (P = 0.009). No clinical benefit was observed after the 1-year period with infusions performed every 4 weeks. These results indicate a favorable effect of passive immunotherapy on the evolution of advanced AIDS.</description><identifier>ISSN: 0027-8424</identifier><identifier>EISSN: 1091-6490</identifier><identifier>DOI: 10.1073/pnas.92.4.1195</identifier><identifier>PMID: 7862660</identifier><language>eng</language><publisher>United States: National Academy of Sciences of the United States of America</publisher><subject>Acquired immune deficiency syndrome ; Acquired Immunodeficiency Syndrome - therapy ; Adult ; AIDS ; AIDS/HIV ; Antibodies ; Blood donation ; Blood plasma ; Blood Transfusion ; Blood transfusions ; Control groups ; Double-Blind Method ; Female ; HIV ; HIV Antibodies - therapeutic use ; HIV Seronegativity ; Human immunodeficiency virus ; Humans ; Immunity (Disease) ; Immunoglobulins, Intravenous - therapeutic use ; Immunotherapy, Adoptive ; Lymphocytes ; Male ; Medical research ; Middle Aged ; Random allocation ; Viruses</subject><ispartof>Proceedings of the National Academy of Sciences - PNAS, 1995-02, Vol.92 (4), p.1195-1199</ispartof><rights>Copyright 1995 The National Academy of Sciences of the United States of America</rights><rights>Copyright National Academy of Sciences Feb 14, 1995</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4305-b4625429ba0faaaabab3be20923f7eb3f5e6341de68c0e211dd26f4766bf8f653</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Uhttp://www.pnas.org/content/92/4.cover.gif</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/2366745$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/2366745$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>230,314,723,776,780,799,881,27903,27904,53769,53771,57995,58228</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/7862660$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vittecoq, D.</creatorcontrib><creatorcontrib>Chevret, S.</creatorcontrib><creatorcontrib>Morand-Joubert, L.</creatorcontrib><creatorcontrib>Heshmati, F.</creatorcontrib><creatorcontrib>Audat, F.</creatorcontrib><creatorcontrib>Bary, M.</creatorcontrib><creatorcontrib>Dusautoir, T.</creatorcontrib><creatorcontrib>Bismuth, A.</creatorcontrib><creatorcontrib>Viard, J. P.</creatorcontrib><creatorcontrib>Barre-Sinoussi, F.</creatorcontrib><creatorcontrib>Bach, J. F.</creatorcontrib><creatorcontrib>Lefrere, J. J.</creatorcontrib><title>Passive Immunotherapy in AIDS: A Double-Blind Randomized Study Based on Transfusions of Plasma Rich in Anti-Human Immunodeficiency Virus 1 Antibodies vs. Transfusions of Seronegative Plasma</title><title>Proceedings of the National Academy of Sciences - PNAS</title><addtitle>Proc Natl Acad Sci U S A</addtitle><description>A randomized double-blind controlled trial was conducted to determine the efficacy of passive immunotherapy in the treatment of symptomatic human immunodeficiency virus (HIV) infection. This trial included 86 symptomatic patients randomized to receive plasma rich in anti-HIV-1 antibody or standard seronegative plasma. Each patient in both groups received a 300-ml infusion every 14 days over a 1-year period, and every 28 days thereafter, in addition to zidovudine and other conventional prophylactic treatments. Plasma donors were selected among symptomless seropositive individuals with a CD4 lymphocyte count ≥400 x 106cells per liter, a negative p24 antigen assay, and a high concentration of anti-p24 antibody. The plasmas were heat-inactivated before infusion. During the study period (day 28-day 365) scheduled by the protocol, clinical benefit from passive immunotherapy was observed in delaying the appearance of the first AIDS-defining event (P < 0.009) and reducing the cumulative incidence of such events, which was estimated 3-fold higher in the control group compared to the treatment group. Seven deaths occurred in the treatment group vs. 11 in the control group (P = 0.27). A total of 47 patients died or exhibited new AIDS-defining events, 18 in the treatment group and 29 in the control group (P = 0.009). No clinical benefit was observed after the 1-year period with infusions performed every 4 weeks. These results indicate a favorable effect of passive immunotherapy on the evolution of advanced AIDS.</description><subject>Acquired immune deficiency syndrome</subject><subject>Acquired Immunodeficiency Syndrome - therapy</subject><subject>Adult</subject><subject>AIDS</subject><subject>AIDS/HIV</subject><subject>Antibodies</subject><subject>Blood donation</subject><subject>Blood plasma</subject><subject>Blood Transfusion</subject><subject>Blood transfusions</subject><subject>Control groups</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>HIV</subject><subject>HIV Antibodies - therapeutic use</subject><subject>HIV Seronegativity</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Immunity (Disease)</subject><subject>Immunoglobulins, Intravenous - therapeutic use</subject><subject>Immunotherapy, Adoptive</subject><subject>Lymphocytes</subject><subject>Male</subject><subject>Medical research</subject><subject>Middle Aged</subject><subject>Random allocation</subject><subject>Viruses</subject><issn>0027-8424</issn><issn>1091-6490</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1995</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkk9v0zAYxiMEGmVw5QSSxWG3BP-Lk6Bdug1YpUlM6-BqOcnr1VViFzup6L7bvhvJWqoCEvhiS8_vefzaeqLoNcEJwRl7v7IqJAVNeEJIkT6JJgQXJBa8wE-jCcY0i3NO-fPoRQhLjHGR5vgoOspyQYXAk-jhWoVg1oBmbdtb1y3Aq9UGGYums4v5BzRFF64vG4jPGmNrdKNs7VpzDzWad329QWcqDGdn0a1XNug-GGcDchpdNyq0Ct2YavGYZjsTX_atsrubatCmMmCrDfpmfB8QeWRKVxsIaB2SvxLn4J2FO9WN427jX0bPtGoCvNrtx9HXTx9vzy_jqy-fZ-fTq7jiDKdxyQVNOS1KhbUaVqlKVgLFBWU6g5LpFATjpAaRVxgoIXVNheaZEKXOtUjZcXS6zV31ZQt1BbbzqpErb1rlN9IpI39XrFnIO7eWfPjl0X6ys3v3vYfQydaECppGWXB9kFlGuMCc_hckIsN5yrIBfPcHuHS9t8MfSIoJSxllYoCSLVR5F4IHvR-YYDmWR47lkQWVXI7lGQxvD5-5x3dtOdBH3y_10H_yL13qvmk6-NEN4JstuAyd83tyGFpkPGU_AZCd5Oo</recordid><startdate>19950214</startdate><enddate>19950214</enddate><creator>Vittecoq, D.</creator><creator>Chevret, S.</creator><creator>Morand-Joubert, L.</creator><creator>Heshmati, F.</creator><creator>Audat, F.</creator><creator>Bary, M.</creator><creator>Dusautoir, T.</creator><creator>Bismuth, A.</creator><creator>Viard, J. 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| ispartof | Proceedings of the National Academy of Sciences - PNAS, 1995-02, Vol.92 (4), p.1195-1199 |
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| source | MEDLINE; Jstor Complete Legacy; PubMed Central; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry |
| subjects | Acquired immune deficiency syndrome Acquired Immunodeficiency Syndrome - therapy Adult AIDS AIDS/HIV Antibodies Blood donation Blood plasma Blood Transfusion Blood transfusions Control groups Double-Blind Method Female HIV HIV Antibodies - therapeutic use HIV Seronegativity Human immunodeficiency virus Humans Immunity (Disease) Immunoglobulins, Intravenous - therapeutic use Immunotherapy, Adoptive Lymphocytes Male Medical research Middle Aged Random allocation Viruses |
| title | Passive Immunotherapy in AIDS: A Double-Blind Randomized Study Based on Transfusions of Plasma Rich in Anti-Human Immunodeficiency Virus 1 Antibodies vs. Transfusions of Seronegative Plasma |
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