For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.
The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. This is a larger study based on the results of our successful pilot study using the same protocol. The 48 week, phase IV trial addresses the issues of the high cost of HIV treatment, adherence problems associated with daily treatment, and cumulative toxicities. Virologic and immunologic parameters, drug levels of efavirenz, adherence, and toxicity will be measured. Subjects will have to be seen at CRI for 6 visits after randomization. Subjects randomized to daily therapy will cross over to 5/2 therapy at 24 weeks if their viral load remains undetectable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. .
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States
CARE-ID
Washington D.C., District of Columbia, United States
Steinhart Medical Associates
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)
Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)
Time frame: 24 weeks
Mean CD4+ T-cell Count Increases From Baseline to Week 24.
Time frame: Baseline to Week 24
Quality of Life
Participant preference of antiretroviral (ART) regimen determined on a scale ranging from 0 to 10. O was defined as "I Perfer taking HIV medications 7 days/week" and 10 was defined as "I perfer 5 days on and 2 days off". We present results of a single question on quality of life experienced while on their study ART regimen.
Time frame: 4 weeks
Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks
Total number of "blip" events in each arm. Blips are defined as HIV RNA \> 50 and \< 200 cps/ml
Time frame: Baseline to week 24
Trough Blood Levels of Efavirenz in Both Arms
blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)
Time frame: 12 or 60 hours
Self-reported Adherence Summary in Both Arms
Percentage of participants who missed one or more doses in weekly regimen.
Time frame: 4, 12 and 24 weeks
Deviation From FOTO Schedule by One Extra Dose
Percentage of FOTO participants who took a dose during weekend planned interuption period
Time frame: 4, 12, 24 weeks
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Treasure Chest Infectious Disease
Vero Beach, Florida, United States
Community Research Initiative of New England - Boston
Boston, Massachusetts, United States
Community Research Initiative of New England - West
Springfield, Massachusetts, United States