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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:
Collaborator:
The Campbell Foundation
Information provided by (Responsible Party):
Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00414635
First received: December 20, 2006
Last updated: February 9, 2012
Last verified: February 2012

December 20, 2006
February 9, 2012
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: efavirenz
  • Drug: tenofovir
  • Drug: emtricitabine
Not Provided
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00414635
06-156
Not Provided
Cal Cohen, 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
February 2012

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