Clinical trial NCT00414635: FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV/AIDS
efavirenz
tenofovir
emtricitabine
FOTO
treatment interruption
Atripla
Truvada
Treatment Experienced
Lead sponsor: Community Research Initiative of New England
Sponsor class: OTHER
Collaborators: name: The Campbell Foundation
First posted: 2006-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is designed to compare the control and the experimental arm groups for 24 weeks of treatment. After 24 weeks, subjects on the control arm then cross over to the experimental intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean CD4+ T-cell Count Increases From Baseline to Week 24.
timeFrame: Baseline to Week 24
measure: Quality of Life
timeFrame: 4 weeks
measure: Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks
timeFrame: Baseline to week 24
measure: Trough Blood Levels of Efavirenz in Both Arms
timeFrame: 12 or 60 hours
measure: Self-reported Adherence Summary in Both Arms
timeFrame: 4, 12 and 24 weeks
measure: Deviation From FOTO Schedule by One Extra Dose
timeFrame: 4, 12, 24 weeks
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Whitman-Walker Clinic
state: District of Columbia
city: Washington, D.C.
country: United States
facility: CARE-ID
state: District of Columbia
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Vero Beach
country: United States
facility: Treasure Chest Infectious Disease
state: Florida
city: Boston
country: United States
facility: Community Research Initiative of New England - Boston
state: Massachusetts
city: Springfield
country: United States
facility: Community Research Initiative of New England - West
state: Massachusetts
Study officials:
affiliation: CRI
name: Calvin J Cohen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: