a5324

A5324:  the MIND Study

 

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

Design: This is a phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC) and Dolutegravir 9DTG) to the current antiretroviral therapy (ART) of HIV-infected individuals with undetectable HIV-1 RNA, who have mild to moderate neurocognitive impairment, with a primary outcome of improvement in neurocognitive performance.

Duration: 96 weeks, 186 participants total

Regimens allowed:

-          EFV + NRTI                                          Prohibitied: Lexiva, Kaletra, Atravirine, Stribild, Viramune

-          RPV + NRTI

-          PI/r + NRTIs

-          PI/r + NNRTI + NRTI

Population: subjects will 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 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 plan to chance regimen.

Inclusion:

-          HIV positive

-          On ART for at least 12 months

-          HIV RNA <50 copies/mL within 90 days of study

Exclusion:

-          Major depressive disorder

-          Traumatic Brain Injury with a clear impact on daily activities

-          Mendal retardation and/or severe educational disability resulting in some dependence for daily activities

-          Substance use with significant impact on daily activities

-          CNS infections or opportunistic conditions: brain abscess (bacterial, mycobacterial, funtal or toxoplasma), meningitis with neurologic impairment, progressive multifocal leukoencephalopathy (PML), or another structural brain lesion with neurological sequelae

-          Prior or current use of any integrase inhibitor or MVC

-          Active syphilis or syphilis treatment within 90 days

-          Current HCV within 90 days of the study, unless shown to be HCV RNS negative

-          Unstable and advanced liver disease

-          Presence of an AIDS-defining opportunistic infection within 180 days prior to entry