Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016
Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 96 papers.
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.
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.
The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment
Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Substudy of A5257
Who cites it
96 citing papers in PubMed, 163 citations in OpenAlex.
- Once-weekly semaglutide in people with HIV-associated lipohypertrophy: a randomised, double-blind, placebo-controlled phase 2b single-centre clinical trial.The lancet. Diabetes & endocrinology · 2024Trial
- Limited Weight Impact After Switching From Boosted Protease Inhibitors to Dolutegravir in Persons With Human Immunodeficiency Virus With High Cardiovascular Risk: A Post Hoc Analysis of the 96-Week NEAT-022 Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Adipokines, Weight Gain and Metabolic and Inflammatory Markers After Antiretroviral Therapy Initiation: AIDS Clinical Trials Group (ACTG) A5260s.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Clinical Predictors of Liver Fibrosis Presence and Progression in Human Immunodeficiency Virus-Associated Nonalcoholic Fatty Liver Disease.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Antiretroviral Therapy Initiation Is Associated With Decreased Visceral and Subcutaneous Adipose Tissue Density in People Living With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Lower Pretreatment Gut Integrity Is Independently Associated With Fat Gain on Antiretroviral Therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- Trial
- Insulin-Like Growth Factor Is Associated with Changes in Body Composition with Antiretroviral Therapy Initiation.AIDS research and human retroviruses · 2017Trial
- Antiretroviral initiation is associated with increased skeletal muscle area and fat content.AIDS (London, England) · 2017Trial
- Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial.Journal of the American Heart Association · 2017Trial
- Improved adipose tissue function with initiation of protease inhibitor-only ART.The Journal of antimicrobial chemotherapy · 2016Trial
- Exploring the impact of Cabotegravir-Rilpivirine long-acting on weight gain, body composition and quality of life in adults living with HIV.HIV medicine · 2026Article
- Article
- Antiretroviral-specific associations between bone hormonal changes and treatment induced weight gain.AIDS (London, England) · 2025Article
- The heart and HIV therapy: exploring the dual cardiovascular impact of antiretroviral treatment - a narrative review.Annals of medicine and surgery (2012) · 2025Review
- Body weight changes in people with HIV starting dolutegravir versus efavirenz-based regimens in a large cohort in rural Tanzania.AIDS (London, England) · 2025Observational
- Article
- Single-Cell Analysis of Subcutaneous Fat Reveals Profibrotic Cells That Correlate With Visceral Adiposity in HIV.The Journal of clinical endocrinology and metabolism · 2024Article
- Sex Differences in Metabolic Disorders of Aging and Obesity in People with HIV.Current HIV/AIDS reports · 2024Review
- Weight Gain and Antiretroviral Therapy.Infectious disease clinics of North America · 2024Review
36 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundFat gain after antiretroviral therapy (ART) occurs, and its association with protease inhibitors (PIs) is unclear.
methodsPeripheral and central fat depots and lean mass were measured using standardized and centrally read abdominal CT scans and whole-body dual-energy absorptiometry scans over a 96-week period in human immunodeficiency virus (HIV)-infected treatment-naive participants. The patients were randomized to tenofovir-emtricitabine (TDF/FTC) plus atazanavir-ritonavir (ATV/r), darunavir-ritonavir (DRV/r), or raltegravir (RAL) in ACTG A5260s, a substudy of A5257. Within arm changes were assessed with signed-rank tests. The 96-week percentage changes in fat and lean mass in the 2 PI arms were not different, thus the PI arms were combined and compared to the RAL arm. Associations between baseline biomarkers and changes in body composition were assessed. All analyses used linear regression models.
results328 patients were randomized (90% male, 44% white non-Hispanic). The median age was 36 years, HIV-1 RNA 4.6 log10 copies/mL, and CD4 349 cells/μL. Overall, at week 96, increases in limb fat (13.4%), subcutaneous (19.9%) and visceral abdominal fat (25.8%), trunk fat (18%), and lean mass (1.8%) were apparent (P < .001 for changes within each arm). Changes for all fat and lean outcomes were not different between the PI arms or between the RAL and the combined PI arms. Higher baseline HIV-1 RNA levels were associated with greater gains in peripheral and central fat.
conclusionsIn treatment-naive participants initiating ART with TDF/FTC, no differences in lean mass and regional fat were found with RAL when compared with ATV/r or DRV/r over 96 weeks. CLINICAL TRIALS REGISTRATION: NCT00811954 and NCT00851799.
Indexed as
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What OpenQuestion holds
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.