Body composition changes after initiation of raltegravir or protease inhibitors: ACTG A5260s

Grace A. McComsey, Carlee Moser, Judith Currier, Heather J. Ribaudo, Pawel Paczuski, Michael P. Dubé, Theodoros Kelesidis, Jennifer Rothenberg, James H. Stein, Todd T. Brown

Research output: Contribution to journalArticle


Background. Fat gain after antiretroviral therapy (ART) occurs, and its association with protease inhibitors (PIs) is unclear. Methods. Peripheral 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. Results. 328 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. Conclusions. In 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.

Original languageEnglish (US)
Pages (from-to)853-862
Number of pages10
JournalClinical Infectious Diseases
Issue number7
StatePublished - Apr 1 2016


  • body composition
  • limb fat
  • lipoatrophy
  • lipodystrophy
  • visceral fat

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Fingerprint Dive into the research topics of 'Body composition changes after initiation of raltegravir or protease inhibitors: ACTG A5260s'. Together they form a unique fingerprint.

  • Cite this

    McComsey, G. A., Moser, C., Currier, J., Ribaudo, H. J., Paczuski, P., Dubé, M. P., Kelesidis, T., Rothenberg, J., Stein, J. H., & Brown, T. T. (2016). Body composition changes after initiation of raltegravir or protease inhibitors: ACTG A5260s. Clinical Infectious Diseases, 62(7), 853-862.