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| Sponsors and Collaborators: |
Community Research Initiative of New England The Campbell Foundation |
| Information provided by: | Community Research Initiative of New England |
| ClinicalTrials.gov Identifier: | NCT00414635 |
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 IV |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Efavirenz Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 60 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| Orlando Immunology Center | |||||
| Orlando, Florida, United States, 32803 | |||||
| Steinhart Medical Associates | |||||
| Miami, Florida, United States, 33133 | |||||
| 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 | |||||
| Community Research Initiative of New England |
| The Campbell Foundation |
| Principal Investigator: | Calvin J Cohen, MD, MSc | CRI |
More Information
Web page of CRI, the nonprofit research group sponsoring the study 
  |
| Study ID Numbers: | 06-156 |
| First Received: | December 20, 2006 |
| Last Updated: | March 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00414635 |
| Health Authority: | United States: Institutional Review Board |
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