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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
History of Changes
Results First Received: July 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: efavirenz
Drug: tenofovir
Drug: emtricitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place between August 21, 2006 and November 9, 2007. Recruitment occured at multiple site locations (research clinics and private practice).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FOTO Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
Control Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.

Participant Flow:   Overall Study
    FOTO     Control  
STARTED     30     30  
COMPLETED     25     28  
NOT COMPLETED     5     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FOTO Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
Control Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
Total Total of all reporting groups

Baseline Measures
    FOTO     Control     Total  
Number of Participants  
[units: participants]
 		  30     30     60  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     30     28     58  
>=65 years     0     2     2  
Age  
[units: years]
Mean (Standard Deviation) 		  42  (8.1)     47  (9.9)     44  (9.4)  
Gender  
[units: participants]
 		     
Female     5     5     10  
Male     25     25     50  
Region of Enrollment  
[units: participants]
 		     
United States     30     30     60  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)   [ Time Frame: 24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Mean CD4+ T-cell Count Increases From Baseline to Week 24.   [ Time Frame: Baseline to Week 24 ]
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3.  Secondary:   Quality of Life   [ Time Frame: 4 weeks ]
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4.  Secondary:   Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks   [ Time Frame: Baseline to week 24 ]
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5.  Secondary:   Trough Blood Levels of Efavirenz in Both Arms   [ Time Frame: 12 or 60 hours ]
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6.  Secondary:   Self-reported Adherence Summary in Both Arms   [ Time Frame: 4, 12 and 24 weeks ]
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7.  Secondary:   Deviation From FOTO Schedule by One Extra Dose   [ Time Frame: 4, 12, 24 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Conclusions are limited by the small "n" studied. The results are only applicable to the specific drug regimen studied and thus can not be generalized to all ART. We only studied individuals already virologically undetectable.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Calvin Cohen, MD
Organization: Community Research Initiative of New England (CRINE)
phone: 617 502 1700
e-mail: ccohen@crine.org



Responsible Party: Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00414635     History of Changes
Other Study ID Numbers: 06-156
Study First Received: December 20, 2006
Results First Received: July 22, 2010
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board