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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by (Responsible Party): | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01309243 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infection |
Drug: emtricitabine/rilpivirine/tenofovir disoproxil fumarate Drug: efavirenz/emtricitabine/tenofovir disoproxil fumarate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 700 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: EFV/FTC/TDF single tablet regimen
Single tablet regimen of efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
|
Drug: efavirenz/emtricitabine/tenofovir disoproxil fumarate
Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg single tablet regimen administered orally on an empty stomach preferably at bedtime (QHS)
Other Name: Atripla®
|
|
Experimental: FTC/RPV/TDF single tablet regimen
Single tablet regimen of emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg
|
Drug: emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg single tablet regimen administered orally with a meal QD
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 149 Study Locations| Study Chair: | Todd Fralich, M.D. | Gilead Sciences |
More Information
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01309243 History of Changes |
| Other Study ID Numbers: | GS-US-264-0110 |
| Study First Received: | March 3, 2011 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV HIV-1 Antiretroviral Treatment-Naïve |
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir disoproxil Tenofovir Efavirenz |
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |