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Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s
- Source :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, vol 62, iss 7
- Publication Year :
- 2016
- Publisher :
- Oxford University Press (OUP), 2016.
-
Abstract
- 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.
- Subjects :
- Male
0301 basic medicine
medicine.medical_treatment
limb fat
HIV Infections
Weight Gain
Medical and Health Sciences
Gastroenterology
Raltegravir Potassium
0302 clinical medicine
immune system diseases
Viral
030212 general & internal medicine
Articles and Commentaries
Lipoatrophy
lipoatrophy
virus diseases
Biological Sciences
Middle Aged
Viral Load
Infectious Diseases
6.1 Pharmaceuticals
Body Composition
HIV/AIDS
RNA, Viral
Female
Lipodystrophy
medicine.symptom
Viral load
medicine.drug
Adult
Microbiology (medical)
medicine.medical_specialty
lipodystrophy
Anti-HIV Agents
visceral fat
Clinical Trials and Supportive Activities
030106 microbiology
Abdominal Fat
Microbiology
03 medical and health sciences
Clinical Research
Internal medicine
medicine
Humans
Protease Inhibitors
body composition
Protease
business.industry
Evaluation of treatments and therapeutic interventions
medicine.disease
Raltegravir
Lean body mass
RNA
business
Weight gain
Subjects
Details
- ISSN :
- 15376591 and 10584838
- Volume :
- 62
- Database :
- OpenAIRE
- Journal :
- Clinical Infectious Diseases
- Accession number :
- edsair.doi.dedup.....f0f7f5f5056893b8a56176ca809f79ec