Finding studies
Finding studies
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Lead
University of Maryland, Baltimore
Description of the study design: The study will enroll 30 HIV-infected patients on a stable ART regimen with a suppressed HIV RNA \< 50 copies/ml for at least one year. Patients will be switched to the experimental regimen (maraviroc 300 mg twice a day plus either raltegravir 400 mg twice a day or dolutegravir 50 mg once a-day) and followed for 96 weeks. The decision to use raltegravir or dolutegravir will be left to investigator/subject preference, as the two integrate inhibitors are largely interchangeable aside from twice daily (raltegravir) vs. daily (dolutegravir) dosing. Primary endpoint: * The primary endpoint is the proportion of patients virologically suppressed (HIV RNA \< 50 copies/ml) at 48 weeks. Definitions: * Virologic suppression is an HIV RNA \< 50 copies/ml. * Virologic failure is an HIV RNA ≥ 50 copies/ml confirmed on 2 separate occasions, separated by \> 1 week after viral suppression. Secondary endpoints: * The percent change in total cholesterol, LDL, and HDL at 48 and 96 weeks. * The number of adverse events. * The proportion of patients who are virologically suppressed (HIV RNA \< 50 copies/ml) at 96 weeks. Exploratory endpoints: * Telomerase activity and telomere length measured at baseline and 24, 48, and 96 weeks.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
