CLINICAL TRIALS PROFILE FOR TENOFOVIR DISOPROXIL FUMARATE
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505(b)(2) Clinical Trials for 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 Tenofovir Disoproxil Fumarate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00002396 ↗ | The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients | Unknown status | Gilead Sciences | Phase 1 | 1969-12-31 | To evaluate the safety of single and multiple doses (28 daily doses) of 9-[2-(R)-[[bis[[(isopropoxycarbonyl)- oxy]methoxy]phosphinoyl]methoxy]propyl]adenine fumarate (PMPA) prodrug administered orally to HIV-infected patients. To determine the pharmacokinetics of single and multiple doses of PMPA prodrug when administered orally to HIV-infected patients. To evaluate the anti-HIV activity of PMPA prodrug, as demonstrated by increases in CD4 cell counts and decreases in HIV RNA, when administered orally as a single dose and daily for 4 weeks to HIV-infected patients with CD4 cell counts of 200 or more cells/mm3. |
| NCT00002415 ↗ | Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients | Completed | Gilead Sciences | Phase 2 | 1969-12-31 | The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied. |
| NCT00002450 ↗ | Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients | Completed | Gilead Sciences | Phase 3 | 1969-12-31 | The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective. |
| NCT00002453 ↗ | A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection | Completed | Gilead Sciences | N/A | 1999-12-01 | This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes. |
| NCT00007436 ↗ | The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients | Unknown status | Gilead Sciences | Phase 3 | 1969-12-31 | The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment. |
| NCT00011089 ↗ | Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations | Unknown status | Gilead Sciences | N/A | 2001-02-01 | The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to HIV-infected patients who have failed other anti-HIV drug combinations, who have few treatment choices available, and whose disease may get worse. This study will allow patients to obtain tenofovir DF before it is approved for marketing. |
| NCT00013520 ↗ | Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 | 1969-12-31 | The purpose of this study is to compare the effectiveness, safety, and tolerability of 3 anti-HIV combination treatments that do not use protease inhibitors (PIs). The current rule for starting treatment of HIV infection is to combine members from different classes of anti-HIV drugs, such as 2 nucleoside reverse transcriptase inhibitors (NRTIs) and either a PI or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, these combinations can be complicated and difficult to take, can cause a number of side effects, and may become ineffective. Combinations that are simpler, better tolerated, and more effective are needed. Because PIs can cause long-term side effects and because HIV can become resistant to many of them at the same time, anti-HIV combination treatments that do not use PIs are being tested. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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