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

This study has been completed.

Sponsor:

Collaborator:

The Campbell Foundation

Information provided by (Responsible Party):

Cal Cohen, Community Research Initiative of New England

ClinicalTrials.gov Identifier:

NCT00414635

First received: December 20, 2006

Last updated: February 9, 2012

Last verified: February 2012

History of Changes

Results First Received: July 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: efavirenz Drug: tenofovir Drug: emtricitabine

Participant Flow

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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

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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
Number of Participants [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

Outcome Measures

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1. Primary:

Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml) [ Time Frame: 24 weeks ]

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2. Secondary:

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

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3. Secondary:

Quality of Life [ Time Frame: 4 weeks ]

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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
e-mail: ccohen@crine.org

No publications provided

Responsible Party:	Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:	NCT00414635 History of Changes
Other Study ID Numbers:	06-156
Study First Received:	December 20, 2006
Results First Received:	July 22, 2010
Last Updated:	February 9, 2012
Health Authority:	United States: Institutional Review Board

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