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| Tracking Information | |||||
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| First Received Date ICMJE | February 4, 2008 | ||||
| Last Updated Date | March 26, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary efficacy endpoint is the proportion of subjects who maintain pure virologic response at HIV 1 RNA threshold of 50 copies/mL (PVR50; lack of confirmed HIV 1 RNA level greater or equal to 50 copies/mL) through Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00615745 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ONCE - Only Nocturnal Combination Evaluation of Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla | ||||
| Official Title ICMJE | A Phase IV, Open-Label, Prospective Observational Study to Evaluate Virological Response in Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla (Efavirenz/Emtricitabine/Tenofovir DF) on an Empty Stomach | ||||
| Brief Summary | A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The individual components of this HAART regimen have demonstrated efficacy and safety in HIV treatment-naive patients and offer simplification that in turn may increase adherence and improve clinical outcomes. This study aims to evaluate the effectiveness (efficacy, safety and tolerability) of a STR simplification strategy in patients on HAART who have achieved viral suppression in a real world clinical setting. |
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| Detailed Description | This is a prospective study to evaluate pure virological response rates in antiretroviral-experienced HIV infected subjects initiating therapy with Atripla. Subjects will be switching to Atripla having already been established on the individual components of efavirenz, emtricitabine, and tenofovir DF. Within the Chelsea and Westminster hospital approximately 540 subjects have been identified who are currently receiving the individual components of Atripla and who would eventually switch to Atripla. The Royal Sussex County Hospital will be included to ensure that recruitment timelines are met. A minimum of 150 subjects will be switched within the first 6 months allowing initial 24 week data for these subjects to be available approximately 12 months post launch. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Drug: Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg | ||||
| Study Arms / Comparison Groups | Experimental: Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg as one tablet orally once daily taken on an empty stomach at bedtime. | ||||
| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | September 2010 | ||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00615745 | ||||
| Responsible Party | Cham Herath, Gilead Sciences | ||||
| Study ID Numbers ICMJE | GS-EU-177-0111, EudraCT Number 2007-005769-36 | ||||
| Study Sponsor ICMJE | Gilead Sciences | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Gilead Sciences | ||||
| Verification Date | March 2009 | ||||
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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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