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

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. Identifier: NCT00414635
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : January 4, 2011
Last Update Posted : September 25, 2017
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

  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.
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Reporting Groups
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 
[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% 
[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 ]

2.  Secondary:   Mean CD4+ T-cell Count Increases From Baseline to Week 24.   [ Time Frame: Baseline to Week 24 ]

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

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

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

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

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

  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