FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment

Phase 4

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Age 18 years or older
CD4 count > or = 200
Viral load < 50
Treatment with a regimen containing efavirenz and tenofovir and lamivudine or emtricitabine for at least 90 days prior to screening

Exclusion Criteria

Detectable HIV RNA on an ultrasensitive assay within the 90 days preceding screening
Prior evidence of intermediate or high level resistance to efavirenz, tenofovir or cytidine analogues
Hepatitis B infection

Arm && Interventions

Group	Intervention	Description
5/2 Intermitent Treatment Arm	Intermitent Dosing	Subjects randomized to the 5/2 intermittent dosing treatment schedule regimen will be prescribed the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mouth daily, for 5 consecutive days per week followed by 2 days off of these medications, 600 mg efavirenz, 300 mg tenoforvir dt and 200 mg emtricitabine, for 48 weeks.
Control Arm with Week 24 Crossover	Intermitent Dosing	Subjects randomized to the control arm will remain on daily dosing of the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mouth daily for 24 weeks. After 24 weeks of daily therapy subjects on this arm may be eligible to cross over to the experimental arm regimen of the coformulated single tablet of 600 mg efavirenz +300 mg tenofovir df +200 mg of emtricitabine on the 5/2 intermittent dosing treatment schedule for the remainder of the study.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)	24 weeks	Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)

Secondary Outcome Measures

Name	Time	Method
Mean CD4+ T-cell Count Increases From Baseline to Week 24.	Baseline to Week 24
Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks	Baseline to week 24	Total number of "blip" events in each arm. Blips are defined as HIV RNA \> 50 and \< 200 cps/ml
Quality of Life	4 weeks	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.
Self-reported Adherence Summary in Both Arms	4, 12 and 24 weeks	Percentage of participants who missed one or more doses in weekly regimen.
Deviation From FOTO Schedule by One Extra Dose	4, 12, 24 weeks	Percentage of FOTO participants who took a dose during weekend planned interuption period
Trough Blood Levels of Efavirenz in Both Arms	12 or 60 hours	blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)

Locations (7): Whitman-Walker Clinic
🇺🇸
Washington, D.C., District of Columbia, United States
Orlando Immunology Center
🇺🇸
Orlando, Florida, United States
CARE-ID
🇺🇸
Washington, D.C., District of Columbia, United States
Steinhart Medical Associates
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Miami, Florida, United States
Treasure Chest Infectious Disease
🇺🇸
Vero Beach, Florida, United States
Community Research Initiative of New England - West
🇺🇸
Springfield, Massachusetts, United States
Community Research Initiative of New England - Boston
🇺🇸
Boston, Massachusetts, United States