Evidence map›Paper›PMID 24445367›Full record

Trial reportAIDS (London, England)2014

Renal events among women treated with tenofovir/emtricitabine in combination with either lopinavir/ritonavir or nevirapine.

Albert Mwafongo, Kondwani Nkanaunena, Yu Zheng, Evelyn Hogg, Wadzanai Samaneka, Lloyd Mulenga, Abraham Siika, Judith Currier, Shahin Lockman, Michael D Hughes and 2 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 20% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Kidney Disease in HIV: Moving beyond HIV-Associated Nephropathy.Journal of the American Society of Nephrology : JASN · 2017
    Review
  8. Article
  9. Article
  10. HIV Infection, Tenofovir, and Urine α1-Microglobulin: A Cross-sectional Analysis in the Multicenter AIDS Cohort Study.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2016
    Article
  11. Observational
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

12 authors at 8 institutions in 5 countries.

Albert MwafongoaUniversity of North Carolina Project, Kamuzu Central Hospital, Lilongwe bJohns Hopkins Project, Queen Elizabeth Central Hospital, Blantyre, Malawi cHarvard School of Public Health, Boston, Massachusetts dSocial & Scientific Systems, Inc., Silver Spring, Maryland, USA eUZ-UCSF Collaborative Research Programme, Harare, Zimbabwe fCenter for Infectious Disease Research, Lusaka, Zambia gMoi University (College of Health Sciences), Eldoret, Kenya hUniversity of California, Los Angeles, Los Angeles, California iBrigham and Women's Hospital, Boston, Massachusetts jUniversity of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.
Kondwani Nkanaunena
Yu Zheng
Evelyn Hogg
Wadzanai Samaneka
Lloyd Mulenga
Abraham Siika
Judith Currier
Shahin Lockman
Michael D Hughes
Mina Hosseinipour
AIDS Clinical Trial Group (ACTG) A5208 Team
Harvard University · USCentre for Infectious Disease Research in Zambia · ZMMinistry of Health · MWMoi University · KEQueen Elizabeth Central Hospital · MWSocial and Scientific Systems (United States) · USUniversity of California, Los Angeles · USUniversity of Zimbabwe-University of California San Francisco · ZW

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
United States Military HIV Research Program (MHRP) Clinical Trials UnitUM1AI108568 · NIAID · WALTER REED ARMY INSTITUTE OF RESEARCH · PI Julie A. Ake, Merlin L Robb · 2014 to 2026
$24.3M
Optimizing Antiretroviral Therapy in HIV K24AI056933 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CURRIER, JUDITH S. · 2003 to 2013
$1.4M
NIAID NIH HHS AI38838NIAID NIH HHS AI68634NIAID NIH HHS K24 AI056933NIAID NIH HHS K24 AI56933NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI108568
6 · The paper itself

Abstract

objectivesTenofovir disoproxil fumarate (TDF) has been associated with renal insufficiency. Co-administration with boosted protease inhibitors, which increases its exposure, may further increase the risk of renal insufficiency.

methodsWe compared the incidence of renal events among women taking TDF co-administered with lopinavir/ritonavir (LPV/r) versus those co-administering TDF with nevirapine (NVP). Renal events were defined as a confirmed drop in creatinine clearance associated with a serum creatinine grade 2 or higher, or that leading to treatment modification.

resultsOverall, 741 HIV-infected women were enrolled into the study. Of these, 24 (3.2%) had reportable renal events (18 in LPV/r arm, six in NVP arm). In multivariate analysis, renal events were significantly associated with the LPV/r arm [odds ratio (OR) 3.12, 95% confidence interval (CI) 1.21, 8.05; P = 0.019], baseline HIV-1 RNA (OR 2.65, 95% CI 1.23, 5.69 per 1 log10 copies/ml higher; P = 0.013) and baseline creatinine clearance (OR 0.83, 95% CI 0.70-0.98 per 10 ml/min higher; P = 0.030). In multivariate analysis evaluating renal events requiring treatment modification, only baseline HIV-1 RNA and creatinine clearance were significantly associated (OR 4.41, 95% CI 1.65, 11.78 per 1 log10 copies/ml higher; P = 0.003 and OR 0.80, 95% CI 0.64, 0.99 per 10 ml/min higher; P = 0.040, respectively).

conclusionThe rates of renal events were relatively low in the two treatment arms. However, patients taking TDF co-administered with LPV/r had significantly more renal events compared to those co-administered with NVP. Furthermore, higher baseline HIV RNA and lower creatinine clearance were associated with the development of renal insufficiency requiring treatment modification.

Indexed as

AdenineAdultAntiviral AgentsCreatinineDeoxycytidineDrug Therapy, CombinationEmtricitabineFemaleHIV-1HIV InfectionsHIV Protease InhibitorsHumansKidney DiseasesLopinavirNevirapineOrganophosphonatesAdenineAntiviral AgentsCreatinineDeoxycytidineEmtricitabineHIV Protease InhibitorsLopinavirNevirapineOrganophosphonatesReverse Transcriptase InhibitorsRitonavirRNA, ViralTenofovir

Identifiers

PMID24445367
PMCPMC4176616
OpenAlexW1252785832

What OpenQuestion holds

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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.