Evidence map›Paper›PMID 22309114›Full record

Trial reportAIDS research and human retroviruses2012

Effect modification by sex and baseline CD4+ cell count among adults receiving combination antiretroviral therapy in Botswana: results from a clinical trial.

C William Wester, Ori M Stitelman, Victor deGruttola, Hermann Bussmann, Richard G Marlink, Mark J van der Laan

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in AIDS research and human retroviruses, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 51% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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 at 2 institutions in 2 countries.

C William WesterHarvard School of Public Health, Boston, Massachusetts, USA. william.wester@vanderbilt.edu
Ori M Stitelman
Victor deGruttola
Hermann Bussmann
Richard G Marlink
Mark J van der Laan
Harvard University · USUniversity of California, Berkeley · US

Funding

The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI Daniel Lingwood · 2004 to 2026
$94.4M
Targeted Learning using adaptive designs for HIV Epidemic control in East AfricaR01AI074345 · NIAID · UNIVERSITY OF CALIFORNIA BERKELEY · PI PETERSEN, MAYA LIV, VANDERLAAN, MARK J · 2007 to 2023
$6.6M
Methods to Advance the HIV Prevention Research AgendaR37AI051164 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI DEGRUTTOLA, VICTOR GERARD · 2012 to 2019
$3.3M
Methods for Long-Term Follow-Up of HIV-Infected PatientsR01AI051164 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI DEGRUTTOLA, VICTOR GERARD · 2002 to 2011
$3.0M
Statistical Techniques for Complex Environmental Epidemiological StudiesR01ES015493 · NIEHS · UNIVERSITY OF CALIFORNIA BERKELEY · PI JEWELL, NICHOLAS P · 2007 to 2010
$1.1M
Risk Factors for the Development of Lactic Acidosis and Pancreatitis Among HAART-K23AI073141 · NIAID · VANDERBILT UNIVERSITY · PI WESTER, C. WILLIAM · 2007 to 2011
$643k
NIAID NIH HHS K23AI073141NIAID NIH HHS P30AI 060354NIAID NIH HHS R01 AI074345NIAID NIH HHS R01 AI074345-04NIAID NIH HHS R01 AI51164NIAID NIH HHS R37 AI051164NIEHS NIH HHS ES015493
6 · The paper itself

Abstract

The Tshepo study was the first clinical trial to evaluate outcomes of adults receiving nevirapine (NVP)-based versus efavirenz (EFV)-based combination antiretroviral therapy (cART) in Botswana. This was a 3 year study (n=650) comparing the efficacy and tolerability of various first-line cART regimens, stratified by baseline CD4(+): <200 (low) vs. 201-350 (high). Using targeted maximum likelihood estimation (TMLE), we retrospectively evaluated the causal effect of assigned NNRTI on time to virologic failure or death [intent-to-treat (ITT)] and time to minimum of virologic failure, death, or treatment modifying toxicity [time to loss of virological response (TLOVR)] by sex and baseline CD4(+). Sex did significantly modify the effect of EFV versus NVP for both the ITT and TLOVR outcomes with risk differences in the probability of survival of males versus the females of approximately 6% (p=0.015) and 12% (p=0.001), respectively. Baseline CD4(+) also modified the effect of EFV versus NVP for the TLOVR outcome, with a mean difference in survival probability of approximately 12% (p=0.023) in the high versus low CD4(+) cell count group. TMLE appears to be an efficient technique that allows for the clinically meaningful delineation and interpretation of the causal effect of NNRTI treatment and effect modification by sex and baseline CD4(+) cell count strata in this study. EFV-treated women and NVP-treated men had more favorable cART outcomes. In addition, adults initiating EFV-based cART at higher baseline CD4(+) cell count values had more favorable outcomes compared to those initiating NVP-based cART.

Indexed as

Acquired Immunodeficiency SyndromeAdolescentAdultAgedAlkynesAnti-HIV AgentsBenzoxazinesBotswanaCD4 Lymphocyte CountCyclopropanesDrug Administration ScheduleDrug Therapy, CombinationFemaleFollow-Up StudiesHumansLikelihood FunctionsAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenzNevirapine

Identifiers

PMID22309114
PMCPMC3423643
OpenAlexW2065551209

What OpenQuestion holds

Textmetadata
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.