Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults.
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01309243
First received: March 3, 2011
Last updated: May 2, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | March 3, 2011 | ||||
| Last Updated Date | May 2, 2012 | ||||
| Start Date ICMJE | February 2011 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary efficacy endpoint is the proportion of subjects who achieve HIV 1 RNA < 50 copies/mL at 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 NCT01309243 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults. | ||||
| Official Title ICMJE | A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults | ||||
| Brief Summary | The purpose of the study is to evaluate the safety and efficacy of a single tablet regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate compared with a single tablet regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults. The FTC/RPV/TDF single tablet regimen could offer an alternative treatment option to patients who wish to simplify or improve the tolerability of their treatment but want to avoid using efavirenz due to concerns about central nervous system side effects, rash, elevations in plasma lipids as well as to women of childbearing potential. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | HIV-1 Infection | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 700 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | July 2012 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Portugal, Puerto Rico, Spain, Switzerland, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01309243 | ||||
| Other Study ID Numbers ICMJE | GS-US-264-0110 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gilead Sciences | ||||
| Study Sponsor ICMJE | Gilead Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Gilead Sciences | ||||
| Verification Date | April 2012 | ||||
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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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