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Sponsors and Collaborators: |
Community Research Initiative of New England The Campbell Foundation |
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Information provided by: | Community Research Initiative of New England |
ClinicalTrials.gov Identifier: | NCT00414635 |
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 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Calvin J Cohen, MD, MSc | CRI |
Study ID Numbers: | 06-156 |
Study First Received: | December 20, 2006 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00414635 |
Health Authority: | United States: Institutional Review Board |
HIV/AIDS efavirenz tenofovir emtricitabine FOTO |
treatment interruption Atripla Truvada Treatment Experienced |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Emtricitabine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |