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RANDOMIZED CONTROLLED TRIAL OF MARAVIROC FOR HIV-ASSOCIATED NEUROCOGNITIVE IMPAIRMENT
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CROI 2021 March 6-10 Reported by Jules Levin
Cecilia M . Shikuma, Lindsay Kohorn, Valerie Wojna, Bruce Shiramizu, Rosa J. Rodriguez-Benitez, Emilee H. Turner, Kalpana Kallianpur, Scott Souza, Andrew Belden, Jacob Bolzenius, Nancy Hanks, Miriam Matos, Lishomwa Ndhlovu, Robert Paul University of Hawaii at Manoa, Honolulu, HI, USA, UniversityofPuertoRico, San Juan, Puerto Rico, University of Missouri St Louis, St Louis, MO, USA
Background: It has been suggested that CCR5 antagonist maraviroc (MVC) improves HIV-associated neurocognitive impairment (NCI).
Methods: A double-blind, placebo-controlled, 48-week, randomized study of MVC vs placebo in people living with HIV (PLWH) on stable ART>1 year with plasma HIV RNA <50 copies/ml and at least mild neurocognitive impairment (NCI) defined as an overall or domain-specific (e.g., executive function, psychomotor speed, attention, and learning and memory) neuropsychological (NP) score < -0.5. Study participants, recruited from Hawaii (HI; n=26) and Puerto Rico (PR; n=22) (ClinicalTrials.gov NCT02159027), were randomized 2:1 to intensification of antiretroviral therapy (ART) with MVC vs with placebo. The primary endpoint was change in global and domain-specific NP Z scores (NPZ) modeled from study entry to week 48. Group comparisons were performed using a two-sample T-test.
Results: A total of 48 participants were entered into the study with 31 individuals randomized to MVC intensification and 17 to placebo. Study follow- up in PR was substantially impacted by Hurricane Maria leaving 39 evaluable subjects (HI 24; PR 15) who completed the final week 48 visit. At baseline, individuals randomized to the two arms were similar in age (median for both groups of 57), gender distribution (MVC vs placebo: 45% vs 53% male), current CD4 (667 vs 693 cells/mm3), self-reported nadir CD4 (150 vs 130 cells/mm3), years HIV positive (22 vs 17 years) and years on ART (17 yrs for both groups), but differed significantly by global NPZ score [MVC: -1.04 (0.62) vs placebo: -0.50 (0.44), p=0.002]. Comparison of change from baseline to week 48 in the two arms (table) revealed significant improvement in the MVC arm in the Learning and Memory NPZ domain, but not in the other domains or global NPZ. The group difference in the Learning and Memory domain score did not survive adjustment for multiple comparisons, although the effect size was 0.89.
Conclusion: This preliminary randomized controlled study found no definitive evidence in favor of MVC intensification for HIV-associated NCI. Blood biomarker analyses are pending.
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