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

Sponsors and Collaborators:	Community Research Initiative of New England The Campbell Foundation
Information provided by:	Community Research Initiative of New England
ClinicalTrials.gov Identifier:	NCT00414635

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 IV

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:

To evaluate virologic control with a 5 day on, 2 day off schedule

Secondary Outcome Measures:

To evaluate change in CD4+ T-cell counts in both arms
To evaluate quality of life in both arms
To evaluate antiretroviral toxicity in both arms
To evaluate change in viral resistance patterns in both arms
To evaluate levels of efavirenz in the blood in both arms
To evaluate adherence in both arms

Estimated Enrollment:

60

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

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
Orlando Immunology Center
Orlando, Florida, United States, 32803
Steinhart Medical Associates
Miami, Florida, United States, 33133
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

Web page of CRI, the nonprofit research group sponsoring the study This link exits the ClinicalTrials.gov site

Study ID Numbers:	06-156
Study First Received:	December 20, 2006
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00414635
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

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Emtricitabine
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Tenofovir
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009