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| Tracking Information | |||||
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| First Received Date ICMJE | May 5, 2006 | ||||
| Last Updated Date | November 12, 2008 | ||||
| Start Date ICMJE | April 2005 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00323492 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada | ||||
| Official Title ICMJE | Pilot Open-Label Randomized Multicentre Trial to Evaluate the Impact of the Substitution of the NRTIs With TRUVADA in a HAART Combination Over the Lipids Profile in HIV+ Infected Patients | ||||
| Brief Summary | This study looks at lipid changes in HIV infected patients when they are switched from existing HIV treatment to a treatment containing Truvada. |
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| Detailed Description | This is a Phase IV, multicenter (in France) and open label study. The study is conducted in two phases, a comparative randomized phase, which serves the primary objective of the study, and a follow up phase. Phase 1, Day-14 to Week12: patients will be, on a 1:1 basis, randomized to two arms: A. the TVD group (substitution of their current NRTIs by TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose) or B. a control group (continuation of previous HAART regimen). This phase of the study serves the Primary objective of the study. Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the TVD group (Arm A) continue with TVD + an NNRTI or PI. Patients who did not switch in Phase 1 to TVD (Arm B) will be proposed to switch in this phase of the study. Patients will be assessed for efficacy and safety during both phases of the study. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study | ||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00323492 | ||||
| Responsible Party | Camille Aubron-Olivier, Gilead Sciences | ||||
| Study ID Numbers ICMJE | GS-FR-164-0109 | ||||
| Study Sponsor ICMJE | Gilead Sciences | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Gilead Sciences | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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