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

HIV Infections Clinical Trial

Official title:

A Randomized Controlled Trial of a Weekly Schedule of Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment (5/2 Intermittent Treatment Schedule) Versus Continuous Treatment in Individuals With Virologic Suppression on This Combination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414635
• Other study ID #: 06-156
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2006
• Last updated: August 24, 2017
• Start date: August 2006
• Est. completion date: December 2009

Study information

• Verified date: July 2017
• Source: Community Research Initiative of New England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.

Description:

The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. This is a larger study based on the results of our successful pilot study using the same protocol. The 48 week, phase IV trial addresses the issues of the high cost of HIV treatment, adherence problems associated with daily treatment, and cumulative toxicities. Virologic and immunologic parameters, drug levels of efavirenz, adherence, and toxicity will be measured. Subjects will have to be seen at CRI for 6 visits after randomization. Subjects randomized to daily therapy will cross over to 5/2 therapy at 24 weeks if their viral load remains undetectable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 years or older

• CD4 count > or = 200

• Viral load < 50

• Treatment with a regimen containing efavirenz and tenofovir and lamivudine or emtricitabine for at least 90 days prior to screening

Exclusion Criteria:

• Detectable HIV RNA on an ultrasensitive assay within the 90 days preceding screening

• Prior evidence of intermediate or high level resistance to efavirenz, tenofovir or cytidine analogues

• Hepatitis B infection

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Intermitent Dosing
Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. .

Locations

Country	Name	City	State
United States	Community Research Initiative of New England - Boston	Boston	Massachusetts
United States	Steinhart Medical Associates	Miami	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Community Research Initiative of New England - West	Springfield	Massachusetts
United States	Treasure Chest Infectious Disease	Vero Beach	Florida
United States	CARE-ID	Washington, D.C.	District of Columbia
United States	Whitman-Walker Clinic	Washington, D.C.	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Community Research Initiative of New England	The Campbell Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)	Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)	24 weeks
Secondary	Mean CD4+ T-cell Count Increases From Baseline to Week 24.		Baseline to Week 24
Secondary	Quality of Life	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.	4 weeks
Secondary	Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks	Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml	Baseline to week 24
Secondary	Trough Blood Levels of Efavirenz in Both Arms	blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)	12 or 60 hours
Secondary	Self-reported Adherence Summary in Both Arms	Percentage of participants who missed one or more doses in weekly regimen.	4, 12 and 24 weeks
Secondary	Deviation From FOTO Schedule by One Extra Dose	Percentage of FOTO participants who took a dose during weekend planned interuption period	4, 12, 24 weeks

External Links

•   Web page of CRI, the nonprofit research group sponsoring the study