Trial Outcomes & Findings for FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment (NCT NCT00414635)

NCT ID: NCT00414635

Last Updated: 2017-09-25

Results Overview

Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2017-09-25

Participant Flow

Recruitment took place between August 21, 2006 and November 9, 2007. Recruitment occured at multiple site locations (research clinics and private practice).

Participant milestones

Measure	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	25	28
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	FOTO n=30 Participants 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 n=30 Participants 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 n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 8.1 • n=5 Participants	47 years STANDARD_DEVIATION 9.9 • n=7 Participants	44 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Per protocol

Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)

Outcome measures

Measure	FOTO n=25 Participants 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 n=28 Participants 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.
Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)	100 Percentage of Participants	86 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Measure	FOTO n=25 Participants 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 n=28 Participants 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.
Mean CD4+ T-cell Count Increases From Baseline to Week 24.	-1.9 cells/ml Interval -50.6 to 46.9	-9.3 cells/ml Interval -57.9 to 39.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The questionnaire was only applicable to FOTO arm

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.

Outcome measures

Measure	FOTO n=25 Participants 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.
Quality of Life	9.5 Units on a Scale Interval 8.0 to 10.0	—

SECONDARY outcome

Timeframe: Baseline to week 24

Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml

Outcome measures

Measure	FOTO n=25 Participants 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 n=28 Participants 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.
Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks	8 blip events	10 blip events

SECONDARY outcome

Timeframe: 12 or 60 hours

blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)

Outcome measures

Measure	FOTO n=25 Participants 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 n=28 Participants 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.
Trough Blood Levels of Efavirenz in Both Arms >1000 nanograms/milliliter (ng/ml)	48 Percentage of Participants	90 Percentage of Participants
Trough Blood Levels of Efavirenz in Both Arms 500-999 nanograms/milliliter (ng/ml)	37 Percentage of Participants	1 Percentage of Participants
Trough Blood Levels of Efavirenz in Both Arms <500 nanograms/milliliter (ng/ml)	15 Percentage of Participants	9 Percentage of Participants

SECONDARY outcome

Timeframe: 4, 12 and 24 weeks

Percentage of participants who missed one or more doses in weekly regimen.

Outcome measures

Measure	FOTO n=25 Participants 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 n=28 Participants 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.
Self-reported Adherence Summary in Both Arms Week 4	10 percentage of participants	17 percentage of participants
Self-reported Adherence Summary in Both Arms Week 12	15 percentage of participants	7 percentage of participants
Self-reported Adherence Summary in Both Arms Week 24	8 percentage of participants	11 percentage of participants

SECONDARY outcome

Timeframe: 4, 12, 24 weeks

Percentage of FOTO participants who took a dose during weekend planned interuption period

Outcome measures

Measure	FOTO n=25 Participants 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.
Deviation From FOTO Schedule by One Extra Dose Week 24	8 Percentage of Participants	—
Deviation From FOTO Schedule by One Extra Dose Week 4	10 Percentage of Participants	—
Deviation From FOTO Schedule by One Extra Dose Week 12	4 Percentage of Participants	—

Adverse Events

FOTO

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	FOTO n=30 participants at risk 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 n=30 participants at risk 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.
Skin and subcutaneous tissue disorders melonoma	0.00% 0/30 • 24 weeks	3.3% 1/30 • Number of events 1 • 24 weeks
General disorders hospitalization status post cardiac catherization	0.00% 0/30 • 24 weeks	3.3% 1/30 • Number of events 1 • 24 weeks
General disorders hospitalization status post gastric banding procedure	0.00% 0/30 • 24 weeks	3.3% 1/30 • Number of events 1 • 24 weeks

Other adverse events

Measure	FOTO n=30 participants at risk 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 n=30 participants at risk 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.
General disorders Cough	6.7% 2/30 • Number of events 2 • 24 weeks	16.7% 5/30 • Number of events 5 • 24 weeks
General disorders nightsweats	0.00% 0/30 • 24 weeks	10.0% 3/30 • Number of events 3 • 24 weeks
General disorders sinusitis	13.3% 4/30 • Number of events 4 • 24 weeks	10.0% 3/30 • Number of events 3 • 24 weeks
General disorders Fever	10.0% 3/30 • Number of events 3 • 24 weeks	10.0% 3/30 • Number of events 3 • 24 weeks

Additional Information

Calvin Cohen, MD

Community Research Initiative of New England (CRINE)

Phone: 617 502 1700

Email: ccohen@crine.org

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER