Conditions: HIV Infections
Keywords: HIV/AIDS efavirenz tenofovir emtricitabine FOTO treatment interruption Atripla Truvada Treatment Experienced
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 60
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Intermitent Dosing
Intervention descriptions: intervention 1: 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. .

Protocol document: