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

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Descriptive Information Fields

Brief Title ^†

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

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

HIV Infections

Intervention ^†

Drug: efavirenz
Drug: tenofovir
Drug: emtricitabine

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00414635

Organization ID

06-156

Secondary IDs ^††

Study Sponsor ^†

Community Research Initiative of New England

Collaborators ^††

The Campbell Foundation

Investigators ^†

Principal Investigator:

Calvin J Cohen, MD, MSc

CRI

Information Provided By

Community Research Initiative of New England

Verification Date

March 2008

First Received Date ^†

December 20, 2006

Last Updated Date

March 21, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.