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rdf:type |
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lifeskim:mentions |
umls-concept:C0019682,
umls-concept:C0035173,
umls-concept:C0039593,
umls-concept:C0042210,
umls-concept:C0042960,
umls-concept:C0205390,
umls-concept:C0301521,
umls-concept:C0378079,
umls-concept:C1414406,
umls-concept:C1549078,
umls-concept:C1997894
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|
pubmed:issue |
3
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|
pubmed:dateCreated |
2000-4-27
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|
pubmed:abstractText |
A phase II efficacy trial was conducted with recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein gp160 (rgp160) in 608 HIV-infected, asymptomatic volunteers with CD4+ cell counts >400 cells/mm3. During a 5-year study, volunteers received a 6-shot primary series of immunizations with either rgp160 or placebo over 6 months, followed by booster immunizations every 2 months. Repeated vaccination with rgp160 was safe and persistently immunogenic. Adequate follow-up and acquisition of endpoints allowed for definitive interpretation of the trial results. There was no evidence that rgp160 has efficacy as a therapeutic vaccine in early-stage HIV infection, as measured at primary endpoints (50% decline in CD4+ cell count or disease progression to Walter Reed stage 4, 5, or 6) or secondary endpoints. A transient improvement was seen in the secondary CD4 endpoint for the vaccination compared with the placebo arm, but this did not translate into improved clinical outcome.
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pubmed:language |
eng
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pubmed:journal |
|
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pubmed:citationSubset |
AIM
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|
pubmed:chemical |
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|
pubmed:status |
MEDLINE
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pubmed:month |
Mar
|
|
pubmed:issn |
0022-1899
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pubmed:author |
pubmed-author:AronsonNN,
pubmed-author:BirxD LDL,
pubmed-author:BrundageJJ,
pubmed-author:DavisCC,
pubmed-author:DeytonLL,
pubmed-author:Foster PiercePP,
pubmed-author:GarnerRR,
pubmed-author:GordinFF,
pubmed-author:HenryDD,
pubmed-author:HollowayWW,
pubmed-author:KerkeringTT,
pubmed-author:Loomis-PriceL DLD,
pubmed-author:Luskin-HawkRR,
pubmed-author:McNeilJJ,
pubmed-author:MichaelNN,
pubmed-author:PoretzDD,
pubmed-author:Ratto-KimSS,
pubmed-author:RedfieldR RRR,
pubmed-author:RenzulloPP,
pubmed-author:RuizNN,
pubmed-author:SitzKK,
pubmed-author:SmithGG,
pubmed-author:TacketCC,
pubmed-author:ThompsonMM,
pubmed-author:TramontEE,
pubmed-author:YangcoBB,
pubmed-author:YarrishRR
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pubmed:issnType |
Print
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|
pubmed:volume |
181
|
|
pubmed:owner |
NLM
|
|
pubmed:authorsComplete |
Y
|
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pubmed:pagination |
881-9
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|
pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:10720508-AIDS Vaccines,
pubmed-meshheading:10720508-Acquired Immunodeficiency Syndrome,
pubmed-meshheading:10720508-Adolescent,
pubmed-meshheading:10720508-Adult,
pubmed-meshheading:10720508-CD4 Lymphocyte Count,
pubmed-meshheading:10720508-Double-Blind Method,
pubmed-meshheading:10720508-Female,
pubmed-meshheading:10720508-HIV Envelope Protein gp160,
pubmed-meshheading:10720508-HIV-1,
pubmed-meshheading:10720508-Humans,
pubmed-meshheading:10720508-Male,
pubmed-meshheading:10720508-Middle Aged,
pubmed-meshheading:10720508-RNA, Viral,
pubmed-meshheading:10720508-Recombinant Proteins,
pubmed-meshheading:10720508-Vaccines, Synthetic
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pubmed:year |
2000
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|
pubmed:articleTitle |
Efficacy testing of recombinant human immunodeficiency virus (HIV) gp160 as a therapeutic vaccine in early-stage HIV-1-infected volunteers. rgp160 Phase II Vaccine Investigators.
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|
pubmed:affiliation |
Walter Reed Army Institute of Research, Division of Retrovirology, Rockville, MD 20850, USA. dbirx@hiv.hjf.org
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Research Support, U.S. Gov't, Non-P.H.S.,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Multicenter Study,
Clinical Trial, Phase II
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