Evidence map›Paper›PMID 31606734›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

Weight Gain Following Initiation of Antiretroviral Therapy: Risk Factors in Randomized Comparative Clinical Trials.

Paul E Sax, Kristine M Erlandson, Jordan E Lake, Grace A Mccomsey, Chloe Orkin, Stefan Esser, Todd T Brown, Jürgen K Rockstroh, Xuelian Wei, Christoph C Carter and 8 more

2 registry-linked trialsOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 372 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
372citing papers in PubMed, 4 pooled it
84.5field-weighted citation impact, top 1% 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.

NCT04903847 phase4unknown statusnot on this mapstarted 2021, after this paper: background citation

Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2

TypeinterventionalSponsorThomas BenfieldRan2021 to 2023Enrolled126ConditionsHiv, HIV Infections, HIV Lipodystrophy, OsteoporosisArmsDolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO], Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
NCT04904406 phase4completednot on this map

Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1

TypeinterventionalSponsorThomas BenfieldRan2020 to 2023Enrolled81ConditionsHiv, HIV Infections, HIV Cardiomyopathy, Weight Change, BodyArmsDolutegravir / Lamivudine Oral Tablet
3 · Its place in the literature

Who cites it

372 citing papers in PubMed, 4 syntheses or guidelines pooled it, 732 citations in OpenAlex.

  1. Weight gain, obesity, and the impact of lifestyle factors among people living with HIV: A systematic review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2025
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  20. DEFINE: A Prospective, Randomized, Phase 4 Trial to Assess a Protease Inhibitor-Based Regimen Switch Strategy to Manage Integrase Inhibitor-Related Weight Gain.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
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312 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 3 countries.

Paul E SaxBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Kristine M ErlandsonUniversity of Colorado School of Medicine, Aurora, Colorado, USA.
Jordan E LakeUniversity of Texas Health Science Center, Houston, Texas, USA.
Grace A MccomseyUniversity Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio, USA.
Chloe OrkinBarts Health National Health Service Trust, London, United Kingdom.
Stefan EsserUniversity Hospital Essen, Essen, Germany.
Todd T BrownJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Jürgen K RockstrohUniversity Hospital Bonn, Bonn, Germany.
Xuelian WeiGilead Sciences, Inc, Foster City, California, USA.
Christoph C CarterGilead Sciences, Inc, Foster City, California, USA.
Lijie ZhongGilead Sciences, Inc, Foster City, California, USA.
Diana M BrainardGilead Sciences, Inc, Foster City, California, USA.
Kathleen MelbourneGilead Sciences, Inc, Foster City, California, USA.
Moupali DasGilead Sciences, Inc, Foster City, California, USA.
Hans-Jürgen StellbrinkInfectious Disease Medical Center, Hamburg, Germany.
Frank A PostKing's College Hospital National Health Service Foundation Trust, London, United Kingdom.
Laura WatersMortimer Market Center, London, United Kingdom.
John R KoetheVanderbilt University Medical Center, Nashville, Tennessee, USA.
Gilead Sciences (United States) · USNational Health Service · GBBrigham and Women's Hospital · USEssen University Hospital · DEJohns Hopkins University · USMortimer Surgery · GBThe University of Texas Health Science Center at Houston · USUniversity Hospital Bonn · DEUniversity Hospitals of Cleveland · USUniversity of Colorado Denver · USVanderbilt University Medical Center · US

Funding

PILOT STUDY--SUBSTRATE METABOLISM IN EXTREMELY LOW BIRTH WEIGHT INFANTSP30DK048520 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI Wendy M Kohrt · 1995 to 2026
$32.6M
NIDDK NIH HHS P30 DK048520
6 · The paper itself

Abstract

backgroundInitiation of antiretroviral therapy (ART) often leads to weight gain. While some of this weight gain may be an appropriate return-to-health effect, excessive increases in weight may lead to obesity. We sought to explore factors associated with weight gain in several randomized comparative clinical trials of ART initiation.

methodsWe performed a pooled analysis of weight gain in 8 randomized controlled clinical trials of treatment-naive people living with human immunodeficiency virus (HIV) initiating ART between 2003 and 2015, comprising >5000 participants and 10 000 person-years of follow-up. We used multivariate modeling to explore relationships between demographic factors, HIV disease characteristics, and ART components and weight change following ART initiation.

resultsWeight gain was greater in more recent trials and with the use of newer ART regimens. Pooled analysis revealed baseline demographic factors associated with weight gain including lower CD4 cell count, higher HIV type 1 RNA, no injection drug use, female sex, and black race. Integrase strand transfer inhibitor use was associated with more weight gain than were protease inhibitors or nonnucleoside reverse transcriptase inhibitors (NNRTIs), with dolutegravir and bictegravir associated with more weight gain than elvitegravir/cobicistat. Among the NNRTIs, rilpivirine was associated with more weight gain than efavirenz. Among nucleoside/nucleotide reverse transcriptase inhibitors, tenofovir alafenamide was associated with more weight gain than tenofovir disoproxil fumarate, abacavir, or zidovudine.

conclusionsWeight gain is ubiquitous in clinical trials of ART initiation and is multifactorial in nature, with demographic factors, HIV-related factors, and the composition of ART regimens as contributors. The mechanisms by which certain ART agents differentially contribute to weight gain are unknown.

Indexed as

Anti-HIV AgentsHIV InfectionsAnti-Retroviral AgentsFemaleHumansRisk FactorsTenofovirWeight GainAnti-HIV AgentsAnti-Retroviral AgentsTenofovirantiretroviral therapyARTHIVobesityweight gain

Identifiers

PMID31606734
PMCPMC7486849
OpenAlexW2979917028

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.