FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
Information source: Community Research Initiative of New England
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: efavirenz (Drug); tenofovir (Drug); emtricitabine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Community Research Initiative of New England Official(s) and/or principal investigator(s): Calvin J Cohen, MD, MSc, Principal Investigator, Affiliation: CRI
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)
Secondary outcome: Mean CD4+ T-cell Count Increases From Baseline to Week 24.Quality of Life Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks Trough Blood Levels of Efavirenz in Both Arms Self-reported Adherence Summary in Both Arms Deviation From FOTO Schedule by One Extra Dose
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
CARE-ID, Washington, District of Columbia 20037, United States
Whitman-Walker Clinic, Washington, District of Columbia 20009, United States
Steinhart Medical Associates, Miami, Florida 33133, United States
Orlando Immunology Center, Orlando, Florida 32803, United States
Treasure Chest Infectious Disease, Vero Beach, Florida 32960, United States
Community Research Initiative of New England - Boston, Boston, Massachusetts 02215, United States
Community Research Initiative of New England - West, Springfield, Massachusetts 01107, United States
Additional Information
Web page of CRI, the nonprofit research group sponsoring the study
Starting date: August 2006
Last updated: February 9, 2012
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