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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
Enrollment 60

Recruitment Details 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  
Arm/Group Title FOTO Control
Hide Arm/Group Description 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). 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.
Period Title: Overall Study
Started 30 30
Completed 25 28
Not Completed 5 2
Arm/Group Title FOTO Control Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
42  (8.1) 47  (9.9) 44  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
5
  16.7%
5
  16.7%
10
  16.7%
Male
25
  83.3%
25
  83.3%
50
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)
Hide Description Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title FOTO Control
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 25 28
Measure Type: Number
Unit of Measure: Percentage of Participants
100 86
2.Secondary Outcome
Title Mean CD4+ T-cell Count Increases From Baseline to Week 24.
Hide Description [Not Specified]
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOTO Control
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 25 28
Mean (95% Confidence Interval)
Unit of Measure: cells/ml
-1.9
(-50.6 to 46.9)
-9.3
(-57.9 to 39.3)
3.Secondary Outcome
Title Quality of Life
Hide Description 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.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The questionnaire was only applicable to FOTO arm
Arm/Group Title FOTO Control
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 25 0
Median (Inter-Quartile Range)
Unit of Measure: Units on a Scale
9.5
(8 to 10)
4.Secondary Outcome
Title Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks
Hide Description Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOTO Control
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 25 28
Measure Type: Number
Unit of Measure: blip events
8 10
5.Secondary Outcome
Title Trough Blood Levels of Efavirenz in Both Arms
Hide Description blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)
Time Frame 12 or 60 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOTO Control
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 25 28
Measure Type: Number
Unit of Measure: Percentage of Participants
>1000 nanograms/milliliter (ng/ml) 48 90
500-999 nanograms/milliliter (ng/ml) 37 1
<500 nanograms/milliliter (ng/ml) 15 9
6.Secondary Outcome
Title Self-reported Adherence Summary in Both Arms
Hide Description Percentage of participants who missed one or more doses in weekly regimen.
Time Frame 4, 12 and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOTO Control
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 25 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 10 17
Week 12 15 7
Week 24 8 11
7.Secondary Outcome
Title Deviation From FOTO Schedule by One Extra Dose
Hide Description Percentage of FOTO participants who took a dose during weekend planned interuption period
Time Frame 4, 12, 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOTO Control
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 25 0
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 10
Week 12 4
Week 24 8
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FOTO Control
Hide Arm/Group Description 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). 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.
All-Cause Mortality
FOTO Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FOTO Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      2/30 (6.67%)    
General disorders     
hospitalization status post cardiac catherization  0/30 (0.00%)  0 1/30 (3.33%)  1
hospitalization status post gastric banding procedure  0/30 (0.00%)  0 1/30 (3.33%)  1
Skin and subcutaneous tissue disorders     
melonoma  0/30 (0.00%)  0 1/30 (3.33%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOTO Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/30 (20.00%)      9/30 (30.00%)    
General disorders     
Cough  2/30 (6.67%)  2 5/30 (16.67%)  5
nightsweats  0/30 (0.00%)  0 3/30 (10.00%)  3
sinusitis  4/30 (13.33%)  4 3/30 (10.00%)  3
Fever  3/30 (10.00%)  3 3/30 (10.00%)  3
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.
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.
Site investigators agree not to individually publish the results of the study. They may participate in a joint publication of the study results with the sponsor.
Results Point of Contact
Name/Title: Calvin Cohen, MD
Organization: Community Research Initiative of New England (CRINE)
Phone: 617 502 1700
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