Evidence map›Paper›PMID 21199294›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2011

CD4+ cell count and risk for antiretroviral drug resistance among women using peripartum nevirapine for perinatal HIV prevention.

B J Dorton, J Mulindwa, M S Li, N T Chintu, C J Chibwesha, F Mbewe, L M Frenkel, J S A Stringer, B H Chi

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00204308 (Addition of Single-dose, Maternal Tenofovir and Emtricitabine to Reduce Non-nucleoside Reverse Transcriptase Inhibitor Resistance Mutations in the Setting of Zidovudine and Nevirapine for Prevention of Mother-to-child HIV Transmission), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 38% 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.

NCT00204308 phase2completednot on this map

Addition of Single-dose, Maternal Tenofovir and Emtricitabine to Reduce Non-nucleoside Reverse Transcriptase Inhibitor Resistance Mutations in the Setting of Zidovudine and Nevirapine for Prevention of Mother-to-child HIV Transmission

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2005 to 2007Enrolled400ConditionsHIV, PregnancyArmsCombination tenofovir-emtricitabine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Trial
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

9 authors at 4 institutions in 2 countries.

B J DortonCentre for Infectious Disease Research, Lusaka, Zambia. bdorts9@gmail.com
J Mulindwa
M S Li
N T Chintu
C J Chibwesha
F Mbewe
L M Frenkel
J S A Stringer
B H Chi
Centre for Infectious Disease Research in Zambia · ZMUniversity of Alabama · USAlabama Department of Public Health · USSeattle Children's Hospital · US

Funding

International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Fogarty International Clinical Research Scholars Support Center @ Vanderbilt-AAMCR24TW007988 · FIC · VANDERBILT UNIVERSITY · PI VERMUND, STEN H. · 2007 to 2011
$27.6M
Reservoirs of drug-resistant HIV-1R01AI058723 · NIAID · SEATTLE CHILDREN'S HOSPITAL · PI FRENKEL, LISA M · 2005 to 2009
$2.0M
A Training Program in International Women's HealthK01TW006670 · FIC · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CHI, BENJAMIN H. · 2005 to 2009
$512k
FIC NIH HHS K01 TW006670FIC NIH HHS R24 TW007988NIAID NIH HHS R01 AI058723NIAID NIH HHS U01 AI068632
6 · The paper itself

Abstract

objectiveTo determine the association between the antenatal CD4(+) cell count and the development of viral drug resistance following the use of peripartum nevirapine (NVP) for perinatal HIV prevention.

designSecondary analysis of data from a previously conducted randomised controlled trial.

settingLusaka, Zambia. POPULATION: HIV-positive pregnant women.

methodsWe analysed the data from a clinical trial of single-dose tenofovir/emtricitabine (TDF/FTC) to reduce viral drug resistance associated with peripartum NVP. The trial population was categorised according to antenatal CD4(+) cell count (200-350, 351-500 and >500 cells/μl).

main outcome measuresThe relative risk for acquiring drug resistance, determined by consensus sequencing and oligonucleotide ligation assay (OLA), was estimated using multivariable logistic regression.

resultsOf the 397 study participants, 119 (30%) had a CD4(+) count of 200-350 cells/μl, 135 (34%) had a CD4(+) count of 351-500 cells/μl and 143 (36%) had a CD4(+) count of >500 cells/μl. Among women receiving no intervention, the risk for drug resistance appeared to increase as the CD4(+) cell count decreased. Participants with CD4(+) cell counts of 200-350 cells/μl randomised to the study arm had the lowest risk, suggesting a higher efficacy of the intervention within this stratum. These results were consistent at 2 and 6 weeks, regardless of how drug resistance was measured.

conclusionsWomen with CD4(+) cell counts of 200-350 cells/μl may be at increased risk for viral drug resistance following the use of peripartum NVP. Given the high prevalence of NVP resistance and the clear benefits of treatment, antiretroviral therapy should be initiated among pregnant women with CD4(+) cell counts of ≤350 cells/μl.

Indexed as

Drug Resistance, ViralAnti-HIV AgentsCD4 Lymphocyte CountFemaleHIV InfectionsHIV SeropositivityHumansInfant, NewbornInfectious Disease Transmission, VerticalNevirapinePerinatal CarePregnancyPregnancy Complications, InfectiousRisk FactorsAnti-HIV AgentsNevirapine

Identifiers

PMID21199294
PMCPMC3076308
OpenAlexW1529596495

What OpenQuestion holds

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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.