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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

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Clinical Trials for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate

Trial ID Title Status Sponsor Phase Summary
NCT01252940 Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF Completed Gilead Sciences Phase 3 The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.
NCT01286740 Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR Completed Gilead Sciences Phase 2 The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.
NCT01309243 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, Antiretr Completed Gilead Sciences Phase 3 The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications. Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.
NCT01500616 Telaprevir Open-Label Study in Co-Infected Patients Completed Janssen-Cilag International NV Phase 3 The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg‑IFN‑alfa and RBV in patients with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment into an ongoing clinical study of telaprevir.
NCT01709084 A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment Active, not recruiting Janssen-Cilag International NV Phase 3 The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).
NCT01777997 FTC/RPV/TDF on T-Cell Activation, CD4 Cell Count, Inflammatory Biomarkers and Viral Reservoir Active, not recruiting National Institute of Allergy and Infectious Diseases (NIAID) Phase 4 This study is being done with people who are infected with HIV, but do not show any signs of having HIV. They are also feeling well without taking HIV medication and have low or undetectable levels of the virus in the blood. The purpose of this study is to see if taking HIV medication (antiretroviral therapy [ART]) will reduce immune activation (a signal that the body is fighting an infection) in people who have HIV, but do not show symptoms. Also this study will help determine how safe the drug is and how well people react to the drug. For this study, the following antiretroviral therapy (ART) will be provided in the form of a single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF). These drugs are combined as one tablet which is approved by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV medication provided is one of the recommended treatments for HIV, including people with low viral loads (how much HIV you have in your body) who are taking HIV drugs for the first time. The risks seen with this HIV medication are the same that one would encounter when taking these drugs outside of the study.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate

Condition Name

Condition Name for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Intervention Trials
HIV-1 Infection 7
Poor Quality Sleep 1
Impaired Cognition 1
Human Immunodeficiency Virus-type 1 Infection 1
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Condition MeSH

Condition MeSH for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Intervention Trials
HIV Infections 1
Acquired Immunodeficiency Syndrome 1
Hepatitis C, Chronic 1
Hepatitis C 1
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Clinical Trial Locations for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Location Trials
United States 121
Canada 16
Germany 7
United Kingdom 6
Italy 5
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Trials by US State

Trials by US State for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Location Trials
Texas 6
Massachusetts 6
Illinois 6
Georgia 6
District of Columbia 6
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Clinical Trial Progress for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate

Clinical Trial Phase

Clinical Trial Phase for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Completed 5
Active, not recruiting 4
Unknown status 1
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Clinical Trial Sponsors for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Sponsor Trials
Gilead Sciences 6
Janssen-Cilag International NV 2
Janssen Pharmaceutical K.K. 1
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Sponsor Type

Sponsor Type for Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Sponsor Trials
Industry 9
Other 2
NIH 1
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