CLINICAL TRIALS PROFILE FOR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
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505(b)(2) Clinical Trials for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
| 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 AND TENOFOVIR DISOPROXIL FUMARATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00039741 ↗ | Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2/Phase 3 | 2002-08-01 | Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications. |
| NCT00039741 ↗ | Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children | Completed | PENTA Foundation | Phase 2/Phase 3 | 2002-08-01 | Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications. |
| NCT00039741 ↗ | Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2/Phase 3 | 2002-08-01 | Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications. |
| NCT00051831 ↗ | Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults | Completed | AIDS Clinical Trials Group | N/A | 2003-10-01 | HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV. |
| NCT00051831 ↗ | Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | N/A | 2003-10-01 | HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV. |
| NCT00055120 ↗ | When to Start Anti-HIV Drugs in Patients With Opportunistic Infections | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 4 | 2003-03-01 | The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
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Clinical Trial Sponsors for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
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