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

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

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.

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

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

Secondary outcome:

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

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.

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

CARE-ID, Washington, District of Columbia 20037, United States

Whitman-Walker Clinic, Washington, District of Columbia 20009, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

Steinhart Medical Associates, Miami, Florida 33133, 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

Web page of CRI, the nonprofit research group sponsoring the study

Last updated: March 21, 2008