Evidence map›Paper›PMID 24169120›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2013

Safety, tolerability, and immunogenicity of repeated doses of dermavir, a candidate therapeutic HIV vaccine, in HIV-infected patients receiving combination antiretroviral therapy: results of the ACTG 5176 trial.

Benigno Rodriguez, David M Asmuth, Roy M Matining, John Spritzler, Jeffrey M Jacobson, Robbie B Mailliard, Xiao-Dong Li, Ana I Martinez, Allan R Tenorio, Franco Lori and 4 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 53 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Application of Nanotechnology in the COVID-19 Pandemic.International journal of nanomedicine · 2021
    Review
  6. Review
  7. Review
  8. In vivo gene delivery mediated by non-viral vectors for cancer therapy.Journal of controlled release : official journal of the Controlled Release Society · 2020
    Review
  9. Review
  10. Article
  11. Nanomedicine applications in women's health: state of the art.International journal of nanomedicine · 2018
    Review
  12. Article
  13. The role of nanotechnology in the treatment of viral infections.Therapeutic advances in infectious disease · 2017
    Review
  14. Article
  15. Review
  16. Novel immunological strategies for HIV-1 eradication.Journal of virus eradication · 2015
    Review
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 1 country.

Benigno Rodriguez*Division of Infectious Diseases and Center for AIDS Research, Case Western Reserve University/University Hospitals of Cleveland, Cleveland, OH; †Division of Infectious Diseases, University of California Davis Medical Center, Sacramento, CA; ‡Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA; §Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine, Philadelphia, PA; ‖University of Pittsburgh, Pittsburgh, PA; ¶Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD; #Department of Medicine, Rush University Medical Center, Chicago, IL; **ViroStatics srl, Sassari, Italy; ††Genetic Immunity, Budapest, Hungary; ‡‡Genetic Immunity, McLean, VA; and §§Social & Scientific Systems, Inc, Silver Spring, MD.
David M Asmuth
Roy M Matining
John Spritzler
Jeffrey M Jacobson
Robbie B Mailliard
Xiao-Dong Li
Ana I Martinez
Allan R Tenorio
Franco Lori
Julianna Lisziewicz
Suria Yesmin
Charles R Rinaldo
Richard B Pollard
University of California Davis Medical Center · USHarvard University · USUniversity of Pittsburgh · USDrexel University · USNational Institute of Allergy and Infectious Diseases · USRush University Medical Center · USSocial and Scientific Systems (United States) · USUniversity Hospitals of Cleveland · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Sharon L. Hillier, JONATHAN KARN · 1994 to 2026
$50.0M
Case Clinical Trials Unit: Administrative Supplement NOSI AI-20-031.UM1AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI George Yendewa · 2012 to 2026
$40.4M
Northwestern University Clinical Trial UnitUM1AI069471 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Chad J Achenbach · 2012 to 2026
$24.6M
Case AIDS Clinical Trials UnitU01AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI LEDERMAN, MICHAEL MARCEL · 2007 to 2011
$14.7M
Northwestern University Clinical Trial UnitU01AI069471 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MURPHY, ROBERT LEO · 2007 to 2011
$12.0M
NIAID NIH HHS AI-069501NIAID NIH HHS AI-36219NIAID NIH HHS AI-68634NIAID NIH HHS AI-68636NIAID NIH HHS P30 AI036219NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI-069471NIAID NIH HHS U01 AI069501NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069501
6 · The paper itself

Abstract

backgroundHIV-specific cellular immune responses are associated with control of viremia and delayed disease progression. An effective therapeutic vaccine could mimic these effects and reduce the need for continued antiretroviral therapy. DermaVir, a topically administered plasmid DNA-nanomedicine expressing HIV (CladeB) virus-like particles consisting of 15 antigens, induces predominantly central memory T-cell responses.

methodsTreated HIV-infected adults (HIV RNA <50 and CD4 >350) were randomized to placebo or escalating DermaVir doses (0.1 or 0.4 mg of plasmid DNA at weeks 1, 7, and 13 in the low- and intermediate-dose groups and 0.8 mg at weeks 0, 1, 6, 7, 12, and 13 in the high-dose group), n = 5-6 evaluable subjects per group. Immunogenicity was assessed by a 12-day cultured interferon-γ enzyme-linked immunosorbent spot assay at baseline and at weeks 9, 17, and 37 using 1 Tat/Rev and 3 overlapping Gag peptide pools (p17, p24, and p15).

resultsGroups were comparable at baseline. The study intervention was well tolerated, without dose-limiting toxicities. Most responses were highest at week 17 (4 weeks after last vaccination) when Gag p24 responses were significantly greater among intermediate-dose group compared with control subjects [median (IQR): 67,600 (5633-74,368) versus 1194 (9-1667)] net spot-forming units per million cells, P = 0.032. In the intermediate-dose group, there was also a marginal Gag p15 response increase from baseline to week 17 [2859 (1867-56,933), P = 0.06], and this change was significantly greater than in the placebo group [0 (-713 to 297), P = 0.016].

conclusionsDermaVir administration was associated with a trend toward greater HIV-specific, predominantly central memory T-cell responses. The intermediate DermaVir dose tended to show the greatest immunogenicity, consistent with previous studies in different HIV-infected patient populations.

Indexed as

AIDS VaccinesAnti-HIV AgentsCD4 Lymphocyte CountCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesDrug Therapy, CombinationHumansImmunization ScheduleRNA, ViralViral LoadViremiaAIDS VaccinesAnti-HIV AgentsDermaVirRNA, Viral

Identifiers

PMID24169120
PMCPMC3858388
OpenAlexW2043212172

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.