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

Study Location:

BaltimoreWashington

Topic:

Cognitive Issues and HIV

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/NCT02406196?term=a5324&rank=1

IRB#:

IRB00050683

Coordinator:

Anna Wimpelberg (Washington)

​Ilene Wiggins, RN (Baltimore)

Enrollment:

Open

Trial Period:

Ongoing

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.

Anna Wimpelberg (Washington)
202-797-3589
awimpelberg@whitman-walker.org


​Ilene Wiggins, RN (Baltimore)
410-614-2766
iwiggin1@jhmi.edu 

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