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

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

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]
<=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

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 ]

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.