Maraviroc and NeuroAIDS Pathogenesis (NCT02159027) | Clinical Trial Compass
CompletedPhase 2/3
Maraviroc and NeuroAIDS Pathogenesis
United States, Puerto Rico48 participantsStarted 2015-06
Plain-language summary
Maraviroc is an antiretroviral medication that may help in improving mental function in HIV infected patients with mental problems by decreasing inflammatory tendencies. We will test this in a clinical trial of 42 HIV infected individuals with some mild to moderate mental problems who are already on HIV medications and doing well. We will add Maraviroc or a sugar pill to their HIV medications and see if mental function improves over 48 weeks. This study will be conducted at 2 sites in Hawaii and Puerto Rico.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Documentation of HIV-1 infection by an FDA approved test at any time prior to study entry.
* Receipt of ARV medication uninterrupted for \> 1 year leading up to the screening period; brief interruptions for toxicity purposes will be evaluated on a case by case basis and may be allowed
* Screening plasma HIV RNA \< 50 copies/ml within 3 months of entry
* Willingness for both males and females of childbearing potential to utilize 2 effective contraception methods (2 separate forms, one of which must be an effective barrier method), be non-heterosexually active or have a an exclusive vasectomized partner from screening throughout the duration of the study treatment and for 30 days following the last dose of study drugs.
* Age between 18 to 70 years.
* Ability and willingness to provide written informed consent Mild to moderate cognitive impairment with global neuropsychological (NP) test (NPZglobal) score of \< -0.5 OR a neurocognitive abnormality (\< -0.5) in at least one cognitive domain known to be typically affected by HIV
Exclusion Criteria:
* Currently receiving or having used a CCR5 antagonist as part of an antiretroviral regimen within 6 months of study entry
* Plasma HIV RNA \> 100 copies/ml at any time within 6 months of study entry
* History of HIV-2
* Diagnosis of cirrhosis
* Active or inadequately treated tuberculosis (TB) infection, or inadequate treatment for a positive purified protein derivative (PPD) test. Adequate treatment is defined …