FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
This study has been completed.
Sponsor:
Community Research Initiative of New England
Collaborator:
The Campbell Foundation
Information provided by (Responsible Party):
Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00414635
First received: December 20, 2006
Last updated: February 9, 2012
Last verified: February 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: efavirenz Drug: tenofovir Drug: emtricitabine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Community Research Initiative of New England:
Primary Outcome Measures:
- Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)
Secondary Outcome Measures:
- Mean CD4+ T-cell Count Increases From Baseline to Week 24. [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Percentage of FOTO participants who took a dose during weekend planned interuption period
| Enrollment: | 60 |
| Study Start Date: | August 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414635
Locations
| United States, District of Columbia | |
| CARE-ID | |
| Washington, District of Columbia, United States, 20037 | |
| Whitman-Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Cal Cohen, Director of Research, Community Research Initiative of New England |
| ClinicalTrials.gov Identifier: | NCT00414635 History of Changes |
| Other Study ID Numbers: | 06-156 |
| Study First Received: | December 20, 2006 |
| Results First Received: | July 22, 2010 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Community Research Initiative of New England:
|
HIV/AIDS efavirenz tenofovir emtricitabine FOTO |
treatment interruption Atripla Truvada Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Tenofovir Tenofovir disoproxil |
Efavirenz Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 17, 2013