Evidence map›Paper›PMID 21765918›Full record

ArticlePloS one2011

Does HAART efficacy translate to effectiveness? Evidence for a trial effect.

Prema Menezes, William C Miller, David A Wohl, Adaora A Adimora, Peter A Leone, William C Miller, Joseph J Eron

Abstract read
In one paragraph

Article in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–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

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Drug-Placebo Additivity in Randomized Clinical Trials.Clinical pharmacology and therapeutics · 2019
    Article
  6. Cohort Profile: The Women's Interagency HIV Study (WIHS).International journal of epidemiology · 2018
    Article
  7. Observational
  8. Article
  9. Article
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

7 authors.

Prema MenezesDivision of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
William C Miller
David A Wohl
Adaora A Adimora
Peter A Leone
William C Miller
Joseph J Eron

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MUENZER, JOSEPH J. · 1985 to 2008
$38.5M
University of North Carolina AIDS Clinical Trials Unit (UNC ACTU)U01AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ERON, JOSEPH J · 2007 to 2011
$21.8M
K24 Mentoring Junior Faculty: The Minority ImperativeK24HD059358 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ADIMORA, ADAORA A · 2008 to 2012
$836k
NCRR NIH HHS M01 RR000046NCRR NIH HHS RR00046NIAID NIH HHS AI 69423NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI50410NIAID NIH HHS U01 AI069423NIAID NIH HHS UM1 AI069423NICHD NIH HHS K24 HD059358NICHD NIH HHS K24HD059358-01
6 · The paper itself

Abstract

backgroundPatients who participate in clinical trials may experience better clinical outcomes than patients who initiate similar therapy within clinical care (trial effect), but no published studies have evaluated a trial effect in HIV clinical trials.

methodsTo examine a trial effect we compared virologic suppression (VS) among patients who initiated HAART in a clinical trial versus in routine clinical care. VS was defined as a plasma HIV RNA ≤ 400 copies/ml at six months after HAART initiation and was assessed within strata of early (1996-99) or current (2000-06) HAART periods. Risk ratios (RR) were estimated using binomial models.

resultsOf 738 persons initiating HAART, 30.6% were women, 61.7% were black, 30% initiated therapy in a clinical trial and 67% (n =  496) had an evaluable six month HIV RNA result. HAART regimens differed between the early and current periods (p < 0.001); unboosted PI regimens (55.6%) were more common in the early and NNRTI regimens (46.4%) were more common in the current period. Overall, 78% (95%CI 74, 82%) of patients achieved VS and trial participants were 16% more likely to achieve VS (unadjusted RR 1.16, 95%CI 1.06, 1.27). Comparing trial to non-trial participants, VS differed by study period. In the early period, trial participants initiating HAART were significantly more likely to achieve VS than non-trial participants (adjusted RR 1.33; 95%CI 1.15, 1.54), but not in the current period (adjusted RR 0.98; 95%CI 0.87, 1.11).

conclusionsA clear clinical trial effect on suppression of HIV replication was observed in the early HAART period but not in the current period.

Indexed as

Antiretroviral Therapy, Highly ActiveClinical Trials as TopicAdultAnti-Retroviral AgentsFemaleHIV InfectionsHumansMaleRisk FactorsRNA, ViralSensitivity and SpecificityTreatment OutcomeAnti-Retroviral AgentsRNA, Viral

Identifiers

PMID21765918
PMCPMC3135599

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.