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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.
Study NCT00414635   Information provided by Community Research Initiative of New England
First Received: December 20, 2006   Last Updated: March 21, 2008   History of Changes

December 20, 2006
March 21, 2008
 
 
To evaluate virologic control with a 5 day on, 2 day off schedule
Same as current
Complete list of historical versions of study NCT00414635 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
HIV Infections
  • Drug: efavirenz
  • Drug: tenofovir
  • Drug: emtricitabine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
 

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
Community Research Initiative of New England
The Campbell Foundation
Principal Investigator: Calvin J Cohen, MD, MSc CRI
Community Research Initiative of New England
March 2008

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