CLINICAL TRIALS PROFILE FOR EMTRICITABINE
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505(b)(2) Clinical Trials for emtricitabine
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Combination | NCT00641641 ↗ | The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection | Completed | Merck Sharp & Dohme Corp. | N/A | 2008-03-01 | The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system. |
| New Combination | NCT00641641 ↗ | The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection | Completed | Kirby Institute | N/A | 2008-03-01 | The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system. |
| New Formulation | NCT02583464 ↗ | Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. | Completed | Laboratorio Elea Phoenix S.A. | Phase 1 | 2014-09-01 | Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina. |
| New Formulation | NCT02583464 ↗ | Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. | Completed | Laboratorio Elea S.A.C.I.F. y A. | Phase 1 | 2014-09-01 | Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for emtricitabine
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00002335 ↗ | The Safety and Effectiveness of 524W91 | Completed | Glaxo Wellcome | Phase 1 | 1969-12-31 | To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients. To determine the effects of food on bioavailability of 524W91. |
| NCT00002362 ↗ | A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs | Suspended | Triangle Pharmaceuticals | Phase 3 | 1999-08-01 | This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs. |
| NCT00002416 ↗ | Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination | Completed | Triangle Pharmaceuticals | Phase 3 | 1969-12-31 | The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug. |
| NCT00006144 ↗ | A Study of HIV-Disease Development in Aging | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 2000-10-01 | The purpose of this study is to better understand the relationship between age and HIV disease progression. This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better. |
| NCT00006208 ↗ | A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs | Unknown status | Triangle Pharmaceuticals | Phase 3 | 2000-08-01 | The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients. |
| NCT00016718 ↗ | Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1/Phase 2 | 2001-08-01 | Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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