Evidence map›Paper›PMID 19219022›Full record

Trial reportNature medicine2009

Phase 2 gene therapy trial of an anti-HIV ribozyme in autologous CD34+ cells.

Ronald T Mitsuyasu, Thomas C Merigan, Andrew Carr, Jerome A Zack, Mark A Winters, Cassy Workman, Mark Bloch, Jacob Lalezari, Stephen Becker, Lorna Thornton and 22 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Nature medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 130 papers.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed
9.3field-weighted citation impact, top 1% 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

130 citing papers in PubMed, 263 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Review
  11. Advances in HIV Gene Therapy.International journal of molecular sciences · 2024
    Review
  12. Article
  13. Review
  14. MicroRNAs in T Cell-Immunotherapy.International journal of molecular sciences · 2022
    Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Nanomedicine based approaches for combating viral infections.Journal of controlled release : official journal of the Controlled Release Society · 2021
    Review
  20. Review

70 more citing papers are in PubMed but not listed here.

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

32 authors at 13 institutions in 3 countries.

Ronald T MitsuyasuCenter for Clinical AIDS Research and Education, University of California-Los Angeles, 9911 West Pico Boulevard, Suite 980, Los Angeles, California 90035, USA. rmitsuya@mednet.ucla.edu
Thomas C Merigan
Andrew Carr
Jerome A Zack
Mark A Winters
Cassy Workman
Mark Bloch
Jacob Lalezari
Stephen Becker
Lorna Thornton
Bisher Akil
Homayoon Khanlou
Robert Finlayson
Robert McFarlane
Don E Smith
Roger Garsia
David Ma
Matthew Law
John M Murray
Christof von Kalle
Julie A Ely
Sharon M Patino
Alison E Knop
Philip Wong
Alison V Todd
Margaret Haughton
Caroline Fuery
Janet L Macpherson
Geoff P Symonds
Louise A Evans
Susan M Pond
David A Cooper
Johnson & Johnson (Australia) · AUSt Vincent's Hospital Sydney · AUNational Centre for Clinical Research on Emerging Drugs · AUStanford University · USAIDS Healthcare Foundation · USAlbion Centre · AUAPLA Health · USGerman Cancer Research Center · DEHealth Innovations (United States) · USQuest Clinical Research (United States) · USRoyal Prince Alfred Hospital · AUUniversity of California, Los Angeles · USUNSW Sydney · AU

Funding

ZDV &3TC NEVIRAPINE COMBINATION THERAPY IN HIV 1 INFECTED INFANTS &M01RR000865 · NCRR · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI WASHINGTON, ARNOLD E. · 1985 to 2011
$43.4M
Virology CoreP30AI028697 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ANTON, PETER A · 1991 to 2018
$39.9M
NCRR NIH HHS M01 RR000865NCRR NIH HHS M01-RR00865NIAID NIH HHS AI28697NIAID NIH HHS P30 AI028697
6 · The paper itself

Abstract

Gene transfer has potential as a once-only treatment that reduces viral load, preserves the immune system and avoids lifetime highly active antiretroviral therapy. This study, which is to our knowledge the first randomized, double-blind, placebo-controlled, phase 2 cell-delivered gene transfer clinical trial, was conducted in 74 HIV-1-infected adults who received a tat-vpr-specific anti-HIV ribozyme (OZ1) or placebo delivered in autologous CD34+ hematopoietic progenitor cells. There were no OZ1-related adverse events. There was no statistically significant difference in viral load between the OZ1 and placebo group at the primary end point (average at weeks 47 and 48), but time-weighted areas under the curve from weeks 40-48 and 40-100 were significantly lower in the OZ1 group. Throughout the 100 weeks, CD4+ lymphocyte counts were higher in the OZ1 group. This study indicates that cell-delivered gene transfer is safe and biologically active in individuals with HIV and can be developed as a conventional therapeutic product.

Indexed as

Genetic TherapyAdultAntigens, CD34Base SequenceDouble-Blind MethodFemaleHIV-1HIV InfectionsHumansMalePlacebosRNA, CatalyticViral LoadAntigens, CD34PlacebosRNA, Catalytic

Identifiers

PMID19219022
PMCPMC2768566
OpenAlexW2082371015

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.