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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: efavirenz
Drug: tenofovir
Drug: emtricitabine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Community Research Initiative of New England:

Primary Outcome Measures:
  • Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)


Secondary Outcome Measures:
  • Mean CD4+ T-cell Count Increases From Baseline to Week 24. [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml

  • Trough Blood Levels of Efavirenz in Both Arms [ Time Frame: 12 or 60 hours ] [ Designated as safety issue: No ]
    blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)

  • Self-reported Adherence Summary in Both Arms [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
    Percentage of participants who missed one or more doses in weekly regimen.

  • Deviation From FOTO Schedule by One Extra Dose [ Time Frame: 4, 12, 24 weeks ] [ Designated as safety issue: No ]
    Percentage of FOTO participants who took a dose during weekend planned interuption period


Enrollment: 60
Study Start Date: August 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414635

Locations
United States, District of Columbia
CARE-ID
Washington, District of Columbia, United States, 20037
Whitman-Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Steinhart Medical Associates
Miami, Florida, United States, 33133
Orlando Immunology Center
Orlando, Florida, United States, 32803
Treasure Chest Infectious Disease
Vero Beach, Florida, United States, 32960
United States, Massachusetts
Community Research Initiative of New England - Boston
Boston, Massachusetts, United States, 02215
Community Research Initiative of New England - West
Springfield, Massachusetts, United States, 01107
Sponsors and Collaborators
Community Research Initiative of New England
The Campbell Foundation
Investigators
Principal Investigator: Calvin J Cohen, MD, MSc CRI
  More Information

Additional Information:
No publications provided

Responsible Party: Cal Cohen, Director of Research, 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

Keywords provided by Community Research Initiative of New England:
HIV/AIDS
efavirenz
tenofovir
emtricitabine
FOTO
treatment interruption
Atripla
Truvada
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Efavirenz
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 20, 2014