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

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ClinicalTrials.gov Identifier: NCT00414635
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : January 4, 2011
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
The Campbell Foundation
Information provided by (Responsible Party):
Community Research Initiative of New England

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Intermitent Dosing

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 		 30   30   60 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      30 100.0%      28  93.3%      58  96.7% 
>=65 years      0   0.0%      2   6.7%      2   3.3% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 42  (8.1)   47  (9.9)   44  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      5  16.7%      5  16.7%      10  16.7% 
Male      25  83.3%      25  83.3%      50  83.3% 
Region of Enrollment 
[Units: Participants]
 		     
United States   30   30   60 


  Outcome Measures

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 ]
  Show Outcome Measure 2

3.  Secondary:   Quality of Life   [ Time Frame: 4 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks   [ Time Frame: Baseline to week 24 ]
  Show Outcome Measure 4

5.  Secondary:   Trough Blood Levels of Efavirenz in Both Arms   [ Time Frame: 12 or 60 hours ]
  Show Outcome Measure 5

6.  Secondary:   Self-reported Adherence Summary in Both Arms   [ Time Frame: 4, 12 and 24 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Deviation From FOTO Schedule by One Extra Dose   [ Time Frame: 4, 12, 24 weeks ]
  Show Outcome Measure 7


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00414635     History of Changes
Other Study ID Numbers: 06-156
First Submitted: December 20, 2006
First Posted: December 21, 2006
Results First Submitted: July 22, 2010
Results First Posted: January 4, 2011
Last Update Posted: September 25, 2017