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A Randomized Trial of Raltegravir Replacement for Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor in Human Immunodeficiency Virus-Infected Women with Lipohypertrophy

  • Author(s): Lake, Jordan Elizabeth
  • Advisor(s): Elashoff, Robert M
  • et al.

Raltegravir (RAL) is not known to induce adipose tissue (AT) changes or severe metabolic perturbations in HIV-infected patients. HIV-infected women with central adiposity and HIV-1 RNA <50 copies/mL on ART continued their NRTIs and were randomized to switch NNRTI or PI to open label RAL immediately or after 24 weeks. The primary endpoint was 24-week between-group change in CT-quantified visceral AT volume. Metabolic parameters, anthropometrics, and patient-reported quality of life assessments were also measured. Thirty-six subjects provided 80% power to detect a 10%, 24-week, between-group difference in visceral AT. Thirty-seven of 39 enrolled subjects completed Week 24. No statistically significant changes in visceral or subcutaneous AT, anthropometrics, glucose, or CRP were observed. Significant improvements in total and LDL cholesterol (p=0.04), self-reported belly size (p=0.02), and composite body size (p = 0.02) were observed in RAL-treated subjects. Body size changes correlated with percent visceral AT change. No RAL-related adverse events occurred.

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