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| Name | Class |
|---|---|
| The Campbell Foundation | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. . |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean CD4+ T-cell Count Increases From Baseline to Week 24. | Baseline to Week 24 | |
| Quality of Life | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Calvin J Cohen, MD, MSc | CRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whitman-Walker Clinic | Washington D.C. | District of Columbia | 20009 | United States | ||
| CARE-ID |
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| Label | URL |
|---|---|
| Web page of CRI, the nonprofit research group sponsoring the study | View source |
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Recruitment took place between August 21, 2006 and November 9, 2007. Recruitment occured at multiple site locations (research clinics and private practice).
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| ID | Title | Description |
|---|---|---|
| FG000 | FOTO | Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay). |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| 4 weeks |
| Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks | Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml | Baseline to week 24 |
| Trough Blood Levels of Efavirenz in Both Arms | blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control) | 12 or 60 hours |
| Self-reported Adherence Summary in Both Arms | Percentage of participants who missed one or more doses in weekly regimen. | 4, 12 and 24 weeks |
| Deviation From FOTO Schedule by One Extra Dose | Percentage of FOTO participants who took a dose during weekend planned interuption period | 4, 12, 24 weeks |
| Washington D.C. |
| District of Columbia |
| 20037 |
| 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 |
Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FOTO | Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay). |
| BG001 | Control | Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Per protocol | Posted | May 2010 | Number | Percentage of Participants | 24 weeks |
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| Secondary | Mean CD4+ T-cell Count Increases From Baseline to Week 24. | Posted | May 2010 | Mean | 95% Confidence Interval | cells/ml | Baseline to Week 24 |
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| Secondary | Quality of Life | 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. | The questionnaire was only applicable to FOTO arm | Posted | May 2010 | Median | Inter-Quartile Range | Units on a Scale | 4 weeks |
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| Secondary | Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks | Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml | Posted | May 2010 | Number | blip events | Baseline to week 24 |
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| Secondary | Trough Blood Levels of Efavirenz in Both Arms | blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control) | Posted | May 2010 | Number | Percentage of Participants | 12 or 60 hours |
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| Secondary | Self-reported Adherence Summary in Both Arms | Percentage of participants who missed one or more doses in weekly regimen. | Posted | May 2010 | Number | percentage of participants | 4, 12 and 24 weeks |
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| Secondary | Deviation From FOTO Schedule by One Extra Dose | Percentage of FOTO participants who took a dose during weekend planned interuption period | Posted | May 2010 | Number | Percentage of Participants | 4, 12, 24 weeks |
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24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FOTO | Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay). | 0 | 30 | 6 | 30 | ||
| EG001 | Control | Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study. | 2 | 30 | 9 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| melonoma | Skin and subcutaneous tissue disorders |
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| hospitalization status post cardiac catherization | General disorders |
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| hospitalization status post gastric banding procedure | General disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | General disorders |
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| nightsweats | General disorders |
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| sinusitis | General disorders |
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| Fever | General disorders |
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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.
Site investigators agree not to individually publish the results of the study. They may participate in a joint publication of the study results with the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Calvin Cohen, MD | Community Research Initiative of New England (CRINE) | 617 502 1700 | ccohen@crine.org |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| >=65 years |
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| Male |
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