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

NCT00414635 | Completed Phase 4 Results

• 1 other identifier: 06-156
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

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.

Conditions

HIV Infections

Keywords

HIV/AIDS; efavirenz; tenofovir; emtricitabine; FOTO; treatment interruption; Atripla; Truvada; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)

  Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)

  24 weeks

Secondary Outcomes (6)

• Mean CD4+ T-cell Count Increases From Baseline to Week 24.

  Baseline to Week 24

• Quality of Life

  4 weeks

• Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks

  Baseline to week 24

• Trough Blood Levels of Efavirenz in Both Arms

  12 or 60 hours

• Self-reported Adherence Summary in Both Arms

  4, 12 and 24 weeks

Study Arms (2)

Control Arm with Week 24 Crossover

OTHER

Subjects randomized to the control arm will remain on daily dosing of the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mouth daily for 24 weeks. After 24 weeks of daily therapy subjects on this arm may be eligible to cross over to the experimental arm regimen of the coformulated single tablet of 600 mg efavirenz +300 mg tenofovir df +200 mg of emtricitabine on the 5/2 intermittent dosing treatment schedule for the remainder of the study.

Drug: Intermitent Dosing

5/2 Intermitent Treatment Arm

EXPERIMENTAL

Subjects randomized to the 5/2 intermittent dosing treatment schedule regimen will be prescribed the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mouth daily, for 5 consecutive days per week followed by 2 days off of these medications, 600 mg efavirenz, 300 mg tenoforvir dt and 200 mg emtricitabine, for 48 weeks.

Drug: Intermitent Dosing

Interventions

Intermitent Dosing DRUG

Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. .

5/2 Intermitent Treatment Arm; Control Arm with Week 24 Crossover

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Community Research Initiative of New England: lead
• The Campbell Foundation: collaborator

Study Sites (7)

Whitman-Walker Clinic

Washington D.C., District of Columbia, 20009, United States

Location

CARE-ID

Washington D.C., District of Columbia, 20037, United States

Location

Steinhart Medical Associates

Miami, Florida, 33133, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Treasure Chest Infectious Disease

Vero Beach, Florida, 32960, United States

Location

Community Research Initiative of New England - Boston

Boston, Massachusetts, 02215, United States

Location

Community Research Initiative of New England - West

Springfield, Massachusetts, 01107, United States

Location

Related Links

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

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Limitations and Caveats

Conclusions are limited by the small "n" studied. The results are only applicable to the specific drug regimen studied and thus can not be generalized to all ART. We only studied individuals already virologically undetectable.

Results Point of Contact

• Title: Calvin Cohen, MD
• Organization: Community Research Initiative of New England (CRINE)

ccohen@crine.org

617 502 1700

Study Officials

• Calvin J Cohen, MD, MSc

  CRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed to compare the control and the experimental arm groups for 24 weeks of treatment. After 24 weeks, subjects on the control arm then cross over to the experimental intervention.

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 21, 2006
• Study Start: August 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 25, 2017
• Results First Posted: January 4, 2011

Record last verified: 2017-07

Locations

US (7)