We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414635
First Posted: December 21, 2006
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Campbell Foundation
Information provided by (Responsible Party):
Community Research Initiative of New England
December 20, 2006
December 21, 2006
July 22, 2010
January 4, 2011
September 22, 2017
August 2006
December 2009   (Final data collection date for primary outcome measure)
Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml) [ Time Frame: 24 weeks ]
Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)
To evaluate virologic control with a 5 day on, 2 day off schedule
Complete list of historical versions of study NCT00414635 on ClinicalTrials.gov Archive Site
  • Mean CD4+ T-cell Count Increases From Baseline to Week 24. [ Time Frame: Baseline to Week 24 ]
  • Quality of Life [ Time Frame: 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.
  • Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks [ Time Frame: Baseline to week 24 ]
    Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml
  • Trough Blood Levels of Efavirenz in Both Arms [ Time Frame: 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)
  • Self-reported Adherence Summary in Both Arms [ Time Frame: 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 [ Time Frame: 4, 12, 24 weeks ]
    Percentage of FOTO participants who took a dose during weekend planned interuption period
  • To evaluate change in CD4+ T-cell counts in both arms
  • To evaluate quality of life in both arms
  • To evaluate antiretroviral toxicity in both arms
  • To evaluate change in viral resistance patterns in both arms
  • To evaluate levels of efavirenz in the blood in both arms
  • To evaluate adherence in both arms
Not Provided
Not Provided
 
FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
A Randomized Controlled Trial of a Weekly Schedule of Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment (5/2 Intermittent Treatment Schedule) Versus Continuous Treatment in Individuals With Virologic Suppression on This Combination
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This study is designed to compare the control and the experimental arm groups for 24 weeks of treatment. After 24 weeks, subjects on the control arm then cross over to the experimental intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: Intermitent Dosing
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. .
  • Control Arm with Week 24 Crossover
    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.
    Intervention: Drug: Intermitent Dosing
  • Experimental: 5/2 Intermitent Treatment Arm
    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.
    Intervention: Drug: Intermitent Dosing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00414635
06-156
Not Provided
Not Provided
Not Provided
Community Research Initiative of New England
Community Research Initiative of New England
The Campbell Foundation
Principal Investigator: Calvin J Cohen, MD, MSc CRI
Community Research Initiative of New England
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
To Top