Evidence map›Paper›PMID 19123865›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2009

Incomplete reconstitution of T cell subsets on combination antiretroviral therapy in the AIDS Clinical Trials Group protocol 384.

Gregory K Robbins, John G Spritzler, Ellen S Chan, David M Asmuth, Rajesh T Gandhi, Benigno A Rodriguez, Gail Skowron, Paul R Skolnik, Robert W Shafer, Richard B Pollard and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 139 papers.

0numbers the graph read from it
0cells of the map it votes in
139citing 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.

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

139 citing papers in PubMed.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Gregory K RobbinsInfectious Diseases Unit, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA. grobbins@partners.org
John G Spritzler
Ellen S Chan
David M Asmuth
Rajesh T Gandhi
Benigno A Rodriguez
Gail Skowron
Paul R Skolnik
Robert W Shafer
Richard B Pollard
AIDS Clinical Trials Group 384 Team

Funding

WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI ROBERT A. PARKER · 2004 to 2026
$94.4M
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
WOMEN'S HEALTH AGENDAU01AI025879 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI LEDERMAN, MICHAEL MARCEL · 1987 to 2006
$14.0M
WOMEN'S HEALTH AGENDAU01AI027659 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI KURITZKES, DANIEL R · 1988 to 2006
$11.8M
WOMEN'S HEALTH AGENDAU01AI027666 · NIAID · STANFORD UNIVERSITY · PI ZOLOPA, ANDREW RICHARD · 1988 to 2006
$11.4M
Induction of HIV-specific Immune ResponsesR01AI066992 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI GANDHI, RAJESH T · 2006 to 2010
$2.7M
Bridging the Gap HIV Trials and Clinical PracticeK01AI062435 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI ROBBINS, GREGORY K · 2005 to 2009
$661k
NIAID NIH HHS AI066992NIAID NIH HHS AI25879NIAID NIH HHS AI27659NIAID NIH HHS AI27666NIAID NIH HHS AI38855NIAID NIH HHS AI38858NIAID NIH HHS IP30AI060354NIAID NIH HHS K01 AI062435NIAID NIH HHS K01AI062435NIAID NIH HHS P30 AI060354NIAID NIH HHS R01 AI066992NIAID NIH HHS U01 AI025879NIAID NIH HHS U01 AI027659NIAID NIH HHS U01 AI027666NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI038858
6 · The paper itself

Abstract

backgroundInitiation of combination antiretroviral therapy (ART) results in higher total CD4 cell counts, a surrogate for immune reconstitution. Whether the baseline CD4 cell count affects reconstitution of immune cell subsets has not been well characterized.

methodsUsing data from 978 patients (621 with comprehensive immunological assessments) from the AIDS [Acquired Immunodeficiency Syndrome] Clinical Trials Group protocol 384, a randomized trial of initial ART, we compared reconstitution of CD4(+), CD4(+) naive and memory, CD4(+) activation, CD8(+), CD8(+) activation, B, and natural killer cells among patients in different baseline CD4(+) strata. Reference ranges for T cell populations in control patients negative for human immunodeficiency virus (HIV) infection were calculated using data from AIDS Clinical Trials Group protocol A5113.

resultsPatients in the lower baseline CD4(+) strata did not achieve total CD4(+) cell counts similar to those of patients in the higher strata during 144 weeks of ART, although CD4(+) cell count increases were similar. Ratios of CD4(+) naive-memory cell counts and CD4(+):CD8(+) cell counts remained significantly reduced in patients with lower baseline CD4(+) cell counts (<or=350 cells/mm(3)). These immune imbalances were most notable for those initiating ART with a baseline CD4(+) cell count <or=200 cells/mm(3), even after adjustment for baseline plasma HIV RNA levels.

conclusionsAfter nearly 3 years of ART, T cell subsets in patients with baseline CD4(+) cell counts >350 cells/mm(3) achieved or approached the reference range those of control individuals without HIV infection. In contrast, patients who began ART with <or=350 CD4(+) cells/mm(3) generally did not regain normal CD4(+) naive-memory cell ratios. These results support current guidelines to start ART at a threshold of 350 cells/mm(3) and suggest that there may be immunological benefits associated with initiating therapy at even higher CD4(+) cell counts.

Indexed as

Antiretroviral Therapy, Highly ActiveAcquired Immunodeficiency SyndromeAdultB-LymphocytesCD4-CD8 RatioCD4 Lymphocyte CountFemaleHumansKiller Cells, NaturalMaleMiddle AgedT-Lymphocyte Subsets

Identifiers

PMID19123865
PMCPMC2676920

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Registered trials

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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.