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Generated: June 20, 2019

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CLINICAL TRIALS PROFILE FOR RILPIVIRINE HYDROCHLORIDE

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Clinical Trials for Rilpivirine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00537966 Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study Recruiting University of Zurich N/A Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
NCT00799864 A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Efficacy of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years Recruiting Janssen Sciences Ireland UC Phase 2 The purpose of this study is to evaluate the pharmacokinetics (what the body does to the drug), safety and effectiveness of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine [AZT]/lamivudine [3TC] or abacavir [ABC]/3TC) in antiretroviral (ARV) treatment.
NCT00855335 A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women Recruiting Janssen Scientific Affairs, LLC Phase 3 The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.
NCT00959894 Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection Completed Janssen Pharmaceuticals Phase 2 The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.
NCT00959894 Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection Completed University of North Carolina, Chapel Hill Phase 2 The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.
NCT01049932 Pre-Exposure Prophylaxis Using TMC278LA Terminated St Stephens Aids Trust Phase 1/Phase 2 Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV treatment. It is hoped that this drug may be used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has been developed. Long acting means that the drug will be present in the blood for longer. It is this formulation of the drug that will be investigated in this study. Subjects will receive the drug by injection. The purpose of this study is to investigate the safety of the drug and how well it is tolerated by the body. The study will look at the levels of the study drug in the subjects blood over the duration of the study.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Rilpivirine Hydrochloride

Condition Name

Condition Name for Rilpivirine Hydrochloride
Intervention Trials
HIV 12
Infection, Human Immunodeficiency Virus 10
HIV-1 Infection 9
HIV Infections 8
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Condition MeSH

Condition MeSH for Rilpivirine Hydrochloride
Intervention Trials
HIV Infections 28
Acquired Immunodeficiency Syndrome 20
Immunologic Deficiency Syndromes 19
Infection 5
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Clinical Trial Locations for Rilpivirine Hydrochloride

Trials by Country

Trials by Country for Rilpivirine Hydrochloride
Location Trials
United States 258
Canada 40
Germany 21
United Kingdom 18
Italy 16
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Trials by US State

Trials by US State for Rilpivirine Hydrochloride
Location Trials
Texas 18
California 16
Florida 15
New York 15
District of Columbia 14
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Clinical Trial Progress for Rilpivirine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Rilpivirine Hydrochloride
Clinical Trial Phase Trials
Phase 4 13
Phase 3 19
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Rilpivirine Hydrochloride
Clinical Trial Phase Trials
Completed 20
Active, not recruiting 14
Recruiting 12
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Clinical Trial Sponsors for Rilpivirine Hydrochloride

Sponsor Name

Sponsor Name for Rilpivirine Hydrochloride
Sponsor Trials
ViiV Healthcare 12
Gilead Sciences 10
St Stephens Aids Trust 6
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Sponsor Type

Sponsor Type for Rilpivirine Hydrochloride
Sponsor Trials
Industry 54
Other 44
NIH 7
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