Evidence map›Paper›PMID 20377413›Full record

Trial reportThe Journal of infectious diseases2010

Anti-HIV-1 activity of weekly or biweekly treatment with subcutaneous PRO 140, a CCR5 monoclonal antibody.

Jeffrey M Jacobson, Melanie A Thompson, Jacob P Lalezari, Michael S Saag, Barry S Zingman, Paul D'Ambrosio, Nancy Stambler, Yakov Rotshteyn, Andre J Marozsan, Paul J Maddon and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00642707 (A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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.

NCT00642707 phase2completednot on this map

A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection

TypeinterventionalSponsorCytoDyn, Inc.Ran2008 to 2008Enrolled44ConditionsHIV -1 Infection, HIV InfectionsArmsPRO 140 (humanized monoclonal antibody to CCR5), Placebo Comparator
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Review
  8. Clinical Characteristics and Outcomes of Coronavirus Disease 2019 Patients Who Received Compassionate-Use Leronlimab.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  9. Repurpose but also (nano)-reformulate! The potential role of nanomedicine in the battle against SARS-CoV2.Journal of controlled release : official journal of the Controlled Release Society · 2021
    Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Repurposing Anti-Cancer Drugs for COVID-19 Treatment.Drug design, development and therapy · 2020
    Review
  15. Review
  16. Genetic Strategies for HIV Treatment and Prevention.Molecular therapy. Nucleic acids · 2018
    Review
  17. Review
  18. Article
  19. Review
  20. New Drugs in the Pipeline for the Treatment of HIV: a Review.Current infectious disease reports · 2017
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Jeffrey M JacobsonDivision of Infectious Diseases and HIV Medicine, Drexel University College of Medicine, Philadelphia, Pennsylvania 19104, USA. jeffrey.jacobson@drexelmed.edu
Melanie A Thompson
Jacob P Lalezari
Michael S Saag
Barry S Zingman
Paul D'Ambrosio
Nancy Stambler
Yakov Rotshteyn
Andre J Marozsan
Paul J Maddon
Stephen A Morris
William C Olson
Progenics Pharmaceuticals (United States) · USAIDS Research Consortium of Atlanta · USDrexel University · USJohns Hopkins University Center for AIDS ResearchQuest Clinical Research (United States) · USUniversity of Alabama at Birmingham · US

Funding

Viral Host And Combinational Influences on PRO 140U19AI066329 · NIAID · PROGENICS PHARMACEUTICALS, INC. · PI OLSON, WILLIAM C · 2005 to 2010
$10.6M
NIAID NIH HHS AI066329NIAID NIH HHS U19 AI066329
6 · The paper itself

Abstract

backgroundPRO 140 is a humanized CCR5 monoclonal antibody that has demonstrated potent antiviral activity when it is administered intravenously to adults infected with CCR5-tropic (R5) human immunodeficiency virus type 1 (HIV-1). This study is the first to evaluate subcutaneous administration.

methodsA randomized, double-blind, placebo-controlled study was conducted among 44 subjects with HIV-1 RNA levels of >5000 copies/mL, CD4(+) cell counts of >300 cells/microL, no receipt of antiretroviral therapy for >or=12 weeks, and only R5 HIV-1 detectable. Subjects received placebo, 162 mg of PRO 140, or 324 mg of PRO 140 weekly for 3 weeks or 324 mg of PRO 140 every other week for 2 doses by means of subcutaneous infusion. Subjects were monitored for 58 days for safety, antiviral effects, and PRO 140 serum concentrations.

resultsSubcutaneous PRO 140 demonstrated potent and prolonged antiretroviral activity. Mean log(10) reductions in HIV-1 RNA level were 0.23, 0.99 (P=.009), 1.37 (P<.001), and 1.65 (P<.001) for the placebo, 162 mg weekly, 324 mg biweekly, and 324 mg weekly dose groups, respectively. Viral loads remained suppressed between successive doses. Treatment was generally well tolerated.

conclusionsThis trial demonstrates proof of concept for a monoclonal antibody administered subcutaneously in HIV-1 infected individuals. Subcutaneous PRO 140 offers the potential for significant dose-dependent HIV-1 RNA suppression and infrequent patient self-administration.

trial registrationClinicalTrials.gov identifier: NCT00642707 .

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDrug Administration ScheduleFemaleHIV-1HIV AntibodiesHIV Fusion InhibitorsHIV InfectionsHumansInjections, SubcutaneousMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedHIV AntibodiesHIV Fusion Inhibitorsleronlimab

Identifiers

PMID20377413
PMCPMC2856743
OpenAlexW2159409179

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.