Clinical trials: Protease Inhibitor
HIV Seropositivity, Metabolic Syndrome
Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
This study will provide data on the switch from a protease inhibitor or efavirenz to the new formulation of raltegravir (RAL) dosed once daily.
- Conditions
- HIV Seropositivity, Metabolic Syndrome, Fatty Liver
- Trial name
- OBERAL (NCT03374358)
- Testing
- Raltegravir
- Where
- Finland
- Volunteers
- 45 people
- Sponsor
- Helsinki University Central Hospital
COVID-19
Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)
The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day…
- Trial name
- NCT04547140
- Testing
- Liquid Alpha1-Proteinase Inhibitor (Human), Standard Medical Treatment
- Where
- 20 sites in United States, Brazil and 3 more
- Volunteers
- 57 people
- Sponsor
- Grifols Therapeutics LLC
Type 1 Diabetes
Incretin Effect and Use After Clinical Islet Transplantation
We aim to study if the administration of medications to increase the secretion of hormones from the intestines can improve glycemic control, reduce insulin use and promote β-cell regeneration/expansion in subjects with type 1…
- Trial name
- NCT00768651
- Testing
- Pantoprazole, Sitagliptin
- Where
- Canada
- Volunteers
- 8 people
- Sponsor
- University of Alberta
Contraception, HIV
Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics
The project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking antiretroviral regimens that include ritonavir to those in women…
- Trial name
- NCT02531321
- Testing
- Levonorgestrel and Ethinyl Estradiol
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Southern California
Human Immunodeficiency Virus
Kaletra: Therapy With Double Protease Inhibitors
Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants
- Trial name
- NCT01075191
- Where
- 17 sites in Germany
- Volunteers
- 65 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
HIV/AIDS, HIV Infections
Treatment Options for Protease Inhibitor-exposed Children
The investigators hypothesize that switching to a regimen based on efavirenz will be as effective and safe as remaining on a regimen based on Lopinavir/ritonavir for HIV-infected children.
- Trial name
- NEVEREST-III (NCT01146873)
- Testing
- Efavirenz (EFV), Lopinavir/ritonavir (LPV/r), Stavudine (D4T)
- Where
- South Africa
- Volunteers
- 300 people
- Sponsor
- Columbia University
HIV Infections
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)
The aim of this study was to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a…
- Trial name
- NCT02422797
- Testing
- DTG 50 mg, RPV 25 mg, CAR
- Where
- 61 sites in United States, Argentina and 9 more
- Volunteers
- 518 people
- Sponsor
- ViiV Healthcare
Pancreatic Adenocarcinoma, Resectable Pancreatic Carcinoma
Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer
This phase II trial studies how well combination chemotherapy with or without oregovomab followed by stereotactic body radiation therapy (SBRT) and nelfinavir mesylate works in treating patients with pancreatic cancer that has…
- Conditions
- Pancreatic Adenocarcinoma, Resectable Pancreatic Carcinoma, Stage I Pancreatic Cancer, Stage IA Pancreatic Cancer
- Trial name
- NCT01959672
- Testing
- 4-Dimensional Computed Tomography, Fluorouracil, Gemcitabine Hydrochloride
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Nebraska
Hypertriglyceridemia, HIV Infection
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in…
- Trial name
- BuLLET (NCT01010399)
- Testing
- Lovaza, fosamprenavir/ritonavir
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Felizarta, Franco, M.D.
Alpha1-antitrypsin Deficiency
Aralast alpha1-proteinase Inhibitor Surveillance Study
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on…
- Trial name
- NCT00313144
- Testing
- ARALAST Alpha1-Proteinase Inhibitor
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Baxalta now part of Shire
Chronic Hepatitis C
Safety and PK Study of MP-424 to Treat Chronic Hepatitis C
The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.
- Trial name
- NCT00591214
- Testing
- MP-424 (Telaprevir)
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Tanabe Pharma Corporation
HIV-1
A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1
This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir…
- Trial name
- NCT00823979
- Testing
- UK-453,061 Dose 1, UK-453,061 Dose 2, Etravirine
- Where
- 63 sites in United States, Brazil and 11 more
- Volunteers
- 105 people
- Sponsor
- Pfizer
HIV Infections
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
To evaluate changes in renal function, efficacy, and safety when switching from a combination of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a combination of raltegravir (MK-0518) plus…
- Trial name
- RANIA (NCT02116660)
- Testing
- Raltegravir (MK-0518), Nevirapine, Lamivudine
- Volunteers
- 11 people
- Sponsor
- Merck Sharp & Dohme LLC
Aging-related Inflammation in HIV-infected Patients
Study of the Effect of Atorvastatin for Reducing Aging-related Complication in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen
Physicians in charge of HIV-infected patients are increasingly being faced to previously unrecognized comorbid conditions such as atherosclerosis and cardiovascular events, loss of renal function, osteopenia/osteoporosis and bone…
- Trial name
- NCT02577042
- Testing
- Raltegravir, PI-based regimen, Atorvastatin
- Where
- Spain
- Volunteers
- 42 people
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Infection, Human Immunodeficiency Virus I
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
- Trial name
- NCT00089583
- Testing
- LEXIVA (GW433908), Ritonavir
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 110 people
- Sponsor
- ViiV Healthcare
Pregnancy, HIV
The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception
The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower levels of a birth control medication called norethindrone.
- Conditions
- Pregnancy, HIV, AIDS
- Trial name
- NET (NCT01667978)
- Testing
- Norethindrone acetate
- Where
- 2 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Alpha1-Antitrypsin Deficiency
Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)
This is a multi-center, open-label study to evaluate the long-term safety of weekly intravenous (IV) infusions of 60 mg/kg alpha1-PI (human), modified process (Alpha-1 MP) in adult participants with Alpha1 Antitrypsin Deficiency…
- Trial name
- NCT02870348
- Testing
- Alpha-1 MP
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- Grifols Therapeutics LLC
Covid19
Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease
A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.
- Trial name
- NCT04723537
- Testing
- Part A: Upamostat 200 mg, Part A: Upamostat 400 mg, Part B: Upamostat 200 or 400 mg
- Where
- 17 sites in United States, South Africa
- Volunteers
- 61 people
- Sponsor
- RedHill Biopharma Limited
Type 2 Diabetes Mellitus
Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
The primary objectives of this study are to determine if sitagliptin treatment is not inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C) after 30 weeks of treatment, and if sitagliptin…
- Trial name
- NCT01189890
- Testing
- sitagliptin phosphate, Glimepiride
- Volunteers
- 480 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)
The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of…
- Trial name
- KALMAR (NCT01068873)
- Testing
- lopinavir/ritonavir plus maraviroc
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Temple University