FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
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| ClinicalTrials.gov Identifier: NCT00414635 |
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Recruitment Status
:
Completed
First Posted
: December 21, 2006
Results First Posted
: January 4, 2011
Last Update Posted
: September 25, 2017
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Sponsor:
Community Research Initiative of New England
Collaborator:
The Campbell Foundation
Information provided by (Responsible Party):
Community Research Initiative of New England
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Intermitent Dosing | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | 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 |
| Study Start Date : | August 2006 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Control Arm with Week 24 Crossover
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.
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Drug: Intermitent Dosing
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. .
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Experimental: 5/2 Intermitent Treatment Arm
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.
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Drug: Intermitent Dosing
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. .
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Primary Outcome Measures
:
- Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml) [ Time Frame: 24 weeks ]Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)
Secondary Outcome Measures
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- Mean CD4+ T-cell Count Increases From Baseline to Week 24. [ Time Frame: Baseline to Week 24 ]
- Quality of Life [ Time Frame: 4 weeks ]Participant preference of antiretroviral (ART) regimen determined on a scale ranging from 0 to 10. O was defined as "I Perfer taking HIV medications 7 days/week" and 10 was defined as "I perfer 5 days on and 2 days off". We present results of a single question on quality of life experienced while on their study ART regimen.
- Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks [ Time Frame: Baseline to week 24 ]Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml
- Trough Blood Levels of Efavirenz in Both Arms [ Time Frame: 12 or 60 hours ]blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)
- Self-reported Adherence Summary in Both Arms [ Time Frame: 4, 12 and 24 weeks ]Percentage of participants who missed one or more doses in weekly regimen.
- Deviation From FOTO Schedule by One Extra Dose [ Time Frame: 4, 12, 24 weeks ]Percentage of FOTO participants who took a dose during weekend planned interuption period
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414635
Locations
| United States, District of Columbia | |
| Whitman-Walker Clinic | |
| Washington, D.C., District of Columbia, United States, 20009 | |
| CARE-ID | |
| Washington, D.C., District of Columbia, United States, 20037 | |
| United States, Florida | |
| Steinhart Medical Associates | |
| Miami, Florida, United States, 33133 | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32803 | |
| 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 |
Additional Information:
| Responsible Party: | Community Research Initiative of New England |
| ClinicalTrials.gov Identifier: | NCT00414635 History of Changes |
| Other Study ID Numbers: |
06-156 |
| First Posted: | December 21, 2006 Key Record Dates |
| Results First Posted: | January 4, 2011 |
| Last Update Posted: | September 25, 2017 |
| Last Verified: | July 2017 |
Keywords provided by Community Research Initiative of New England:
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HIV/AIDS efavirenz tenofovir emtricitabine FOTO |
treatment interruption Atripla Truvada Treatment Experienced |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Emtricitabine Efavirenz Antiviral Agents |
Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |