Evidence map›Paper›PMID 24396625›Full record

ArticleISRN AIDS2013

Improvements in Immune Function and Activation with 48-Week Darunavir/Ritonavir-Based Therapy: GRACE Substudy.

Christos Tsoukas, Louise Gilbert, Trevor Lewis, George Hatzakis, Ron Falcon, Joseph Mrus

Registry-linked trialAbstract read
In one paragraph

Article in ISRN AIDS, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00381303 (GRACE), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT00381303 phase3completednot on this map

GRACE: An Open-label, Multicenter Trial to Compare the Efficacy, Safety, and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race, When Administered in Combination With an Individually Optimized Background Regimen Over a 48-week Treatment Period.

TypeinterventionalSponsorTibotec, IncRan2006 to 2008Enrolled429ConditionsHIV, InfectiousArmsdarunavir, ritonavir
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

6 authors.

Christos TsoukasDepartment of Microbiology and Immunology, McGill University Health Centre, Room A5-140, 1650 Cedar Avenue, Montreal, QC, Canada H3G 1A4.
Louise GilbertMontreal General Hospital, Flowcytometry Laboratory, 1650 Cedar Avenue, Room C10-166, Montreal, QC, Canada H3G 1A4.
Trevor LewisDepartment of Microbiology and Immunology, McGill University Health Centre, Room A5-140, 1650 Cedar Avenue, Montreal, QC, Canada H3G 1A4.
George HatzakisLAC+USC Medical Center, 1200 N State Street, Room IPT-C4E100, Los Angeles, CA 90033, USA.
Ron FalconJanssen Services, LLC, Clinical Affairs, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA.
Joseph MrusJanssen Services, LLC, Clinical Affairs, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective. During the course of HIV infection, progressive immune deficiency occurs. The aim of this prospective substudy was to evaluate the recovery of functional immunity in a subset of patients from the GRACE (Gender, Race, And Clinical Experience) study treated with a DRV/r-based regimen. Methods. The recovery of functional immunity with a darunavir/ritonavir-based regimen was assessed in a subset of treatment-experienced, HIV-1 infected patients from the GRACE study. Results. 19/32 patients (59%) enrolled in the substudy were virologically suppressed (<50 copies/mL). In these patients, median (range) CD4+ cell count increased from 222 (2, 398) cells/mm(3) at baseline to 398 (119, 812) cells/mm(3) at Week 48. CD8+% decreased significantly from baseline to Week 48 (P = .03). Proliferation of CD4+ lymphocytes in response to CD3+/CD28+, phytohemagglutinin, and pokeweed was significantly increased (P < .01) by Week 12. Proliferation in response to Candida and tetanus was significantly increased by Week 48 (P < .01 and P = .014, resp.). Staphylococcal enterotoxin B-stimulated tumor necrosis factor-alpha and interleukin-2 in CD4+ cells was significantly increased by Week 12 (P = .046) and Week 48 (P < .01), respectively. Conclusions. Darunavir/ritonavir-based therapy demonstrated improvements in CD4+ cell recovery and association with progressive functional immune recovery over 48 weeks. This trial is registered with NCT00381303.

Identifiers

PMID24396625
PMCPMC3874356

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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.