Assessing risk of a short-term antiretroviral therapy discontinuation as a read-out of viral control in immune-based therapy.

Abstract:

:Although analytical treatment interruption is used as a strategy to test immunotherapeutic agents in HIV-infection, it may pose a risk for study participants. The potential risks of short-term interruption of antiretroviral therapy (ART) during treatment with an autologous dendritic cell immune-based therapy (AGS-004-001) were assessed using data from a subgroup of subjects in the strategies for management of antiretroviral therapy (SMART) study with matched eligibility criteria. A retrospective subgroup analysis of the SMART study population using the eligibility criteria and treatment stopping rules of AGS-004-001 study was analyzed. Key inclusion criteria for AGS-004-001 study were applied to the data collected from participants of the SMART study. There were 440 of 2,720 on the drug conservation arm and 436 of 2,752 on the viral suppression arm that matched the AGS-004-001 inclusion criteria and were used in the SMART subgroup analysis. In the first 16 weeks following randomization into the SMART study there were no deaths in either subgroup. There were two AIDS-related events in the drug conservation subgroup and one in the viral suppression subgroup, making the overall risk of AIDS-related events 2 per 100 person years (0.005%) and 1 per 100 person years (0.002%) in the two subgroups, respectively. There were 6/440 subjects (1.4%) in the drug conservation subgroup and 4/436 subjects (0.92%) in the viral suppression subgroup who experienced Grade 2 adverse events. These results demonstrated that analytical treatment interruption within the context of highly selective, closely monitored studies assessing the antiviral activity of immune-based agents should be an acceptable strategy for at least 16 weeks.

journal_name

J Med Virol

authors

Routy JP,Boulassel MR,Nicolette CA,Jacobson JM

doi

10.1002/jmv.23297

subject

Has Abstract

pub_date

2012-06-01 00:00:00

pages

885-9

issue

6

eissn

0146-6615

issn

1096-9071

journal_volume

84

pub_type

杂志文章,随机对照试验
  • Molecular characterization of human respiratory syncytial virus subtype B: a novel genotype of subtype B circulating in China.

    abstract::Human respiratory syncytial virus (HRSV) is major pathogen of lower respiratory tract infections in infants and young children worldwide. There have been many studies regarding HRSV subgroup A (HRSV-A) G protein genetic variability but little information about HRSV subtype B (HRSV-B) G protein genetic diversity and mo...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.23960

    authors: Ren L,Xiao Q,Zhou L,Xia Q,Liu E

    更新日期:2015-01-01 00:00:00

  • Neurotropism of a high-passage XJ strain of Junín virus.

    abstract::Guinea pig infection with a highly passaged XJ prototype strain of Junín virus by the intramuscular route (IM) was carried out in order to study viral tropism modification in this host. The neurotropism of this strain was demonstrated by viral isolation, meningitis, and by the presence of Junín antigens as shown by im...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1890150208

    authors: Oubiña JR,Carballal G

    更新日期:1985-02-01 00:00:00

  • Risk factors and clinical characteristics of patients with nosocomial influenza A infection.

    abstract::Influenza is a public health burden, responsible for more than half a million deaths worldwide each year and explosive outbreaks in-hospital care units. At present, little is known about clinical characteristics and outcomes with nosocomial influenza infection. To assess clinical characteristics and outcome between no...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.25652

    authors: Naudion P,Lepiller Q,Bouiller K

    更新日期:2020-08-01 00:00:00

  • Development of a reverse transcription-polymerase chain reaction assay for diagnosis of lymphocytic choriomeningitis virus infection and its use in a prospective surveillance study.

    abstract::Lymphocytic choriomeningitis virus (LCMV), which is one of several arenaviruses that are pathogenic for humans, causes encephalitis and meningitis in man. In this study, single-stage and nested reverse transcription-polymerase chain reaction (RT-PCR) assays were developed that targeted the GPC and N genes of LCMV. Bot...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:

    authors: Park JY,Peters CJ,Rollin PE,Ksiazek TG,Gray B,Waites KB,Stephensen CB

    更新日期:1997-02-01 00:00:00

  • Shedding of herpes simplex virus type 1 into saliva in patients with orofacial fracture.

    abstract::Shedding of herpes simplex virus type 1 (HSV-1) into saliva was studied in 83 patients with orofacial fractures. Infectious virus was isolated from 14 of 83 patients (16.8%) with no detectable herpetic lesion during hospitalization. Of the 83 patients, 44 (53%) had HSV-1 specific antibody. Virus shedding into saliva w...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1890280205

    authors: Kameyama T,Futami M,Nakayoshi N,Sujaku C,Yamamoto S

    更新日期:1989-06-01 00:00:00

  • Effect of Phyllanthus amarus on duck hepatitis B virus replication in vivo.

    abstract::Nine ducks congenitally infected with the duck hepatitis B virus (DHBV) were treated either orally (four ducks for 10 weeks) or intraperitoneally (five ducks for 12 weeks) with the Indian traditional herbal remedy Phyllanthus amarus. Compared to placebo-treated control ducks, these treatments did not result in a reduc...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1890320404

    authors: Niu JZ,Wang YY,Qiao M,Gowans E,Edwards P,Thyagarajan SP,Gust I,Locarnini S

    更新日期:1990-12-01 00:00:00

  • High prevalence of TT virus-related DNA (90%) and diverse viral genotypes in Norwegian blood donors.

    abstract::Early estimates of the prevalence of TTV viremia in healthy adults of developed countries were in the order of 1--10 %, while similar estimates in Third World countries were considerably higher. Using three different PCRs, TTV-related DNA was detected in serum from 180 out of the 201 Norwegian blood donors tested, ind...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1062

    authors: Huang LY,Oystein Jonassen T,Hungnes O,Grinde B

    更新日期:2001-07-01 00:00:00

  • Measles immunity and response to revaccination of a young adult population in Israel.

    abstract::In order to evaluate the true immune status and the effect of revaccination on a young adult population, we collected serum samples from 289 military recruits who were vaccinated during an outbreak in 1991. Most vaccinees, age 18-25 years, had apparently been immunized once before as infants. Sera collected just prior...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/(SICI)1096-9071(199611)50:3<249::AID-JMV7>

    authors: Mendelson E,Duvdevani P,Varsano N,Lerman Y,Slepon R,Dagan R,Cohen D,Danon Y,Shohat T

    更新日期:1996-11-01 00:00:00

  • Spectrum of hepatitis E virus infection in India.

    abstract::A solid phase enzyme linked immunosorbent assay (ELISA) that detects IgM and IgG to hepatitis E virus (HEV) was used to study seroepidemiology in 40 healthy subjects and 227 consecutive patients with liver diseases in an endemic area. Fifty-two of the liver diseases patients (22.9 percent) had acute hepatitis E. In co...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1890430316

    authors: Khuroo MS,Rustgi VK,Dawson GJ,Mushahwar IK,Yattoo GN,Kamili S,Khan BA

    更新日期:1994-07-01 00:00:00

  • Human bocavirus isolated from children with acute respiratory tract infections in Korea, 2010-2011.

    abstract::Human bocavirus (HBoV) was first recognized in respiratory samples in 2005. The clinical importance of HBoV infection remains unclear. This report describes the clinical features and molecular phylogeny of HBoV isolates in children with acute respiratory infections. Nasopharyngeal aspirates were obtained from 1,528 ch...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.23880

    authors: Ahn JG,Choi SY,Kim DS,Kim KH

    更新日期:2014-12-01 00:00:00

  • Outbreaks of hepatitis A in England and Wales associated with two co-circulating hepatitis A virus strains.

    abstract::During 2002, an upsurge in frequency of hepatitis A outbreaks among injecting drug users was observed in England and Wales. As lack of risk factor information and the high mobility of the cases made linkage of outbreaks difficult, the relationship of nucleotide sequences in the VP1/2PA junction of the hepatitis A viru...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.21207

    authors: Ngui SL,Granerod J,Jewes LA,Crowcroft NS,Teo CG,2002 Hepatitis A Outbreaks Investigation Network.

    更新日期:2008-07-01 00:00:00

  • South African G4P[6] asymptomatic and symptomatic neonatal rotavirus strains differ in their NSP4, VP8*, and VP7 genes.

    abstract::Over the past decade, a G4P[6] strain has been found to be circulating in different neonatal wards in the Pretoria area. This endemic strain was associated with both asymptomatic and symptomatic infection, providing the opportunity to undertake a molecular study of some of the putative "virulence" genes. The genes enc...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/1096-9071(200010)62:2<208::aid-jmv12>3.0.c

    authors: Pager CT,Alexander JJ,Steele AD

    更新日期:2000-10-01 00:00:00

  • Efficacy of low-dose intermittent interferon-alpha monotherapy in patients infected with hepatitis C virus genotype 1b who were predicted or failed to respond to pegylated interferon plus ribavirin combination therapy.

    abstract::The efficacy of interferon (IFN) monotherapy for non-responders to pegylated interferon (PEG-IFN) plus ribavirin (RBV) combination therapy is still unclear. To evaluate the impact of IFN monotherapy on biochemical response, 200 consecutive patients infected with HCV genotype 1b, who received low-dose intermittent IFN-...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.21224

    authors: Akuta N,Suzuki F,Kawamura Y,Yatsuji H,Sezaki H,Suzuki Y,Hosaka T,Kobayashi M,Kobayashi M,Arase Y,Ikeda K,Kumada H

    更新日期:2008-08-01 00:00:00

  • Epstein-Barr virus, B cell lymphoproliferative disease, and SCID mice: modeling T cell immunotherapy in vivo.

    abstract::Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disease (PTLD) arises in up to 10% of organ transplant recipients and is fatal in ∼50% of cases. PTLD can be modeled in SCID mice using EBV+ve human B lymphoblastoid cell lines (BLCLs), and the current study investigated intraperitoneal (ip) inocu...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.22164

    authors: Johannessen I,Bieleski L,Urquhart G,Watson SL,Wingate P,Haque T,Crawford DH

    更新日期:2011-09-01 00:00:00

  • Patterns of serum type 1 and type 2 immune markers in healthy carriers of HTLV-I.

    abstract::Type 1 immunity appears to be diminished in healthy Japanese carriers of human T-lymphotropic virus type I (HTLV-I), but type 2 status remains undetermined. To further examine the subclinical effect of HTLV-I on host immunity, we measured serum antibodies to the Epstein-Barr virus (EBV) in 415 healthy Japanese adults ...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.20633

    authors: Birmann BM,Mueller NE,Okayama A,Hsieh CC,Tsubouchi H,Harn D,Stuver SO

    更新日期:2006-06-01 00:00:00

  • Antibody assays for varicella-zoster virus: comparison of competitive enzyme-linked immunosorbent assay (ELISA), competitive radioimmunoassay (RIA), complement fixation, and indirect immunofluorescence assays.

    abstract::The competitive ELISA test was compared with competitive RIA, complement fixation, and indirect fluorescent antibody test for the detection of antibody to varicella-zoster virus (VZV). ELISA and RIA were the most sensitive tests, being tenfold as sensitive as indirect immunofluorescence and 20 times as sensitive as co...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1890130407

    authors: Wreghitt TG,Tedder RS,Nagington J,Ferns RB

    更新日期:1984-01-01 00:00:00

  • Early inhibition of nitric oxide production increases HSV-1 intranasal infection.

    abstract::Here, we studied the role of nitric oxide (NO) production during the first steps of the respiratory infection of BALB/c mice with herpes simplex virus type 1 (HSV-1), strain F. Nitric oxide synthase II (NOS-II) mRNA and protein were detected by reverse transcription (RT)-PCR and dot blot, respectively in samples of lu...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.20093

    authors: Gamba G,Cavalieri H,Courreges MC,Massouh EJ,Benencia F

    更新日期:2004-06-01 00:00:00

  • Comparison of the hypervariable region of hepatitis C virus genomes in plasma and liver.

    abstract::Nucleotide sequences of the hypervariable region of hepatitis C virus genomes obtained from plasma change rapidly during the course of infection and are believed to play a part in immunological escape and consequently in the development of persistent infection. It is not known, however, whether these changes also occu...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1890460103

    authors: Sakamoto N,Enomoto N,Kurosaki M,Asahina Y,Maekawa S,Koizumi K,Sakuma I,Murakami T,Marumo F,Sato C

    更新日期:1995-05-01 00:00:00

  • The mechanistic rationale of drugs, primary endpoints, geographical distribution of clinical trials against severe acute respiratory syndrome-related coronavirus-2: A systematic review.

    abstract::There are numerous ongoing studies assessing treatment options for preventing, treating, and managing complications of coronavirus disease-2019 disease. The objective of this study was to do a systematic review and critical appraisal of the ongoing clinical trials with an aim to provide insight into the various interv...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.26338

    authors: Venkatesulu BP,Thoguluva Chandrasekar V,Giridhar P,V P,Patel HK,Manteuffel J

    更新日期:2021-02-01 00:00:00

  • Preliminary characterization of murine cytomegaloviruses with insertional and deletional mutations in the M34 open reading frame.

    abstract::A viable virus could not be recovered from a mutant murine cytomegalovirus (MCMV) BAC in which the M34 ORF had been deleted (BACDeltaM34). In contrast, an M34 mutant virus (RcM34), in which the M34 ORF was interrupted by transposon insertion at nt 44,827 of the Smith MCMV BAC, was attenuated in replication both in tis...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.21211

    authors: Baluchova K,Kirby M,Ahasan MM,Sweet C

    更新日期:2008-07-01 00:00:00

  • Characterization of natural Epstein-Barr virus infection and replication in smooth muscle cells from a leiomyosarcoma.

    abstract::Cells from a leiomyosarcoma tumor (LMS-1) from a patient with the acquired immunodeficiency syndrome (AIDS) were explanted, cultured in vitro, and studied by phase-contrast microscopy for morphologic and growth characteristics, immunostaining for cell markers, EBER in situ hybridization and polymerase chain reaction f...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:

    authors: Jenson HB,Montalvo EA,McClain KL,Ench Y,Heard P,Christy BA,Dewalt-Hagan PJ,Moyer MP

    更新日期:1999-01-01 00:00:00

  • Repression of tax-mediated human t-lymphotropic virus type 1 transcription by inducible cAMP early repressor (ICER) protein in peripheral blood mononuclear cells.

    abstract::Human T-lymphotropic virus type 1 (HTLV-1) infection causes adult T-cell leukemia and is characterized by long periods of clinical latency with low levels of viral production. Transcription of HTLV-1 is controlled through sequences in the promoter and enhancer regions of the long terminal repeat of the integrated prov...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:

    authors: Newbound GC,O'Rourke JP,Collins ND,Andrews JM,DeWille J,Lairmore MD

    更新日期:2000-10-01 00:00:00

  • Hepatitis C virus genotype 4d in Southern Italy: reconstruction of its origin and spread by a phylodynamic analysis.

    abstract::Hepatitis C Virus (HCV) genotype 4 predominates in Middle East and Central Africa countries. Recently, it has become also prevalent in Southern European countries where it is thought to have been introduced through immigration and the movement of intravenous drug users. In Italy, the prevalence of genotype 4 is partic...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.23384

    authors: Ciccozzi M,Equestre M,Costantino A,Marascio N,Quirino A,Lo Presti A,Cella E,Bruni R,Liberto MC,Focà A,Pisani G,Zehender G,Ciccaglione AR

    更新日期:2012-10-01 00:00:00

  • A comparison of epidemiologic and immunologic features of bronchiolitis caused by influenza virus and respiratory syncytial virus.

    abstract::We studied epidemiologic and immunologic factors in infants with bronchiolitis caused by influenza virus. The proportion of these infants who were male and who had an immediate family member with a history of asthma was similar to that of a control group of infants with respiratory syncytial virus (RSV) bronchiolitis....

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.20268

    authors: Garofalo RP,Hintz KH,Hill V,Patti J,Ogra PL,Welliver RC Sr

    更新日期:2005-02-01 00:00:00

  • Altered patterns of norovirus GII.b recombinant forms in gastroenteritis outbreaks in Victoria, Australia, 2002-2005 compared to 2006-2011.

    abstract::GII.b norovirus is an obligatory recombinant with an open reading frame (ORF) 1 comprising the GII.b genotype and the ORF 2 region corresponding to one of a number of other norovirus genotypes. GII.b is the second most common genotype after GII.4 associated with gastroenteritis outbreaks in Victoria, Australia. The st...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.23633

    authors: Bruggink LD,Marshall JA

    更新日期:2013-08-01 00:00:00

  • Herd immunity and fatal cases of influenza among the population exposed to poultry and wild birds in Russian Asia in 2013-2014.

    abstract::In total 1,525 blood serum samples were collected in October, 2013 in Russian Asia from people who reside in territories that are at high risk for emergence of influenza viruses with pandemic potential. Presence of antibodies to influenza viruses in the sera was tested in hemagglutination inhibition test. None of the ...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.24301

    authors: Ilyicheva T,Abdurashitov M,Durymanov A,Susloparov I,Goncharova N,Kolosova N,Mikheev V,Ryzhikov A

    更新日期:2016-01-01 00:00:00

  • Significance of postnatal mother-to-child transmission of human T-lymphotropic virus type-I on the development of adult T-cell leukemia/lymphoma.

    abstract::In order to shed light on the mode of HTLV-I infection by mother-to-child transmission, we examined sera of school children in a highly endemic town on two separate occasions at a 6-year interval. The carrier rates in ages 15-17, 8.7 and 2.1%, were significantly higher than that in ages 6-8, 1.7 and 0.4%, in studies. ...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1890200307

    authors: Sugiyama H,Doi H,Yamaguchi K,Tsuji Y,Miyamoto T,Hino S

    更新日期:1986-11-01 00:00:00

  • Laboratory confirmation of congenital rubella syndrome in infants: an eye hospital based investigation.

    abstract::A total of 190 specimens from South Indian children aged 0-59 months with ocular anomalies consistent with suspected congenital rubella syndrome (CRS) were investigated. Twenty-six of the 65 infants (40%) were confirmed as CRS by detection of rubella specific IgM. Rubella RNA was detected in 41 samples from 26 infants...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.21097

    authors: Rajasundari TA,Sundaresan P,Vijayalakshmi P,Brown DW,Jin L

    更新日期:2008-03-01 00:00:00

  • Differential IgG avidity to rubella virus structural proteins.

    abstract::Avidity maturation of IgG antibody responses directed against the structural proteins of rubella virus (E1, E2, and C) as well as whole rubella virus (RV) was assessed at sequential time intervals in 7 individuals following serologically confirmed wild rubella infection. Individual structural proteins were purified fr...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.1890360310

    authors: Mauracher CA,Mitchell LA,Tingle AJ

    更新日期:1992-03-01 00:00:00

  • Epidemiology and clinical features of rotavirus, adenovirus, and astrovirus infections and coinfections in children with acute gastroenteritis prior to rotavirus vaccine introduction in Meerut, North India.

    abstract::There are limited reports on the etiology of multiple enteric viruses causing acute gastroenteritis (AGE) in North India. In the present study we have determined the prevalence of three enteric viruses, namely rotavirus, astrovirus (AstV) and adenovirus (AdV) in a total of 312 diarrheic children (<5 years) hospitalize...

    journal_title:Journal of medical virology

    pub_type: 杂志文章

    doi:10.1002/jmv.25645

    authors: Akdag AI,Gupta S,Khan N,Upadhayay A,Ray P

    更新日期:2020-08-01 00:00:00