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

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

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

Baseline Characteristics

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