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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

Page last updated: August 23, 2015

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