A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
Anna Wimpelberg (Washington)
Ilene Wiggins, RN (Baltimore)
ACTG A5324 is a phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC) and Dolutegravir (DTG) to the current antiretroviral therapy (ART) of HIV-infected individuals with undetectable (<50 copies/mL) plasma HIV-1 RNA, who have mild to moderate neurocognitive impairment, with a primary outcome of improvement in neurocognitive performance.
Men and women > 18 years old who have HIV-associated neurocognitive disorder (HAND) as defined by the Frascati criteria, plasma HIV-1 RNA <50 copies/mL within 90 days prior to entry, and no more than one plasma HIV-1 RNA ≥50 and <200 copies/mL in the past 6 months prior to entry with a subsequent plasma HIV-1 RNA <50 copies/mL, and on stable ART for at least 12 months prior to entry with no plans to change treatment.