Clinical trials: Protease Inhibitor
Healthy Participants
A Study to Learn About the Medicine (PF-07321332 or Nirmatrelvir/Ritonavir) in Healthy Lactating Women
The main purpose of this study is to measure the level of active ingredient of the study medicine (nirmatrelvir) that is secreted in human breast milk when it is given to healthy breastfeeding women.
- Trial name
- NCT05441215
- Testing
- nirmatrelvir, ritonavir
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Type 2 Diabetes Mellitus
Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast…
- Trial name
- NCT01340768
- Testing
- Sitagliptin, Sulfonylurea, Metformin
- Volunteers
- 870 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors
The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to…
- Trial name
- NCT00002418
- Testing
- Emivirine, Hydroxyurea, Nevirapine
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Bristol-Myers Squibb
Emphysema, Alpha 1-antitrypsin Deficiency (AATD)
Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor [alpha1-PI] [Human]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with…
- Trial name
- SPARK (NCT01213043)
- Testing
- Prolastin-C, 60 mg/kg, Prolastin-C, 120 mg/kg
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Grifols Therapeutics LLC
HIV Infections
T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs
The purpose of this study is to compare the change in viral load (amount of HIV in the blood) of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs.
- Trial name
- NCT00008528
- Testing
- Enfuvirtide
- Where
- 37 sites in United States, Canada
- Volunteers
- 525 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C
A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone
The purpose of this study is to evaluate the effect of steady-state (constant concentration of medication in the blood) TMC435 (150 mg, once a day) on the steady state pharmacokinetics (what the body does to the medication) of R…
- Trial name
- NCT00915564
- Testing
- TMC435, Methadone
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infection
TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use
The purpose of this study is to determinate the effectiveness, safety and tolerability (how well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) called TMC125.
- Trial name
- NCT00225303
- Testing
- TMC125
- Volunteers
- 116 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV-1 Patients
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose…
- Trial name
- KaleEAST (NCT01379703)
- Where
- 103 sites in Czechia, Georgia and 10 more
- Volunteers
- 2,288 people
- Sponsor
- Abbott
Healthy Participants
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation…
- Trial name
- NCT01619527
- Testing
- darunavir, cobicistat
- Where
- Belgium
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
HIV Infections
Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor…
- Trial name
- NCT00002220
- Testing
- Indinavir sulfate, Efavirenz, Levocarnitine
- Where
- 11 sites in United States
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Prostate Cancer, Neuroendocrine Tumors
A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.
An open-label, multicenter, Phase 1b/2 study to identify the recommended Phase 2 dose and assess the efficacy and safety of BXCL701 administered orally, as monotherapy and in combination with PEMBRO, in patients with mCRPC.
- Conditions
- Prostate Cancer, Neuroendocrine Tumors, Small Cell Carcinoma
- Trial name
- NCT03910660
- Testing
- BXCL701 plus Pembrolizumab, BXCL701 monotherapy
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 98 people
- Sponsor
- BioXcel Therapeutics Inc
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
Hepatitis C, Chronic
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)
This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic…
- Trial name
- NCT01278134
- Testing
- RO5024048, danoprevir, peginterferon alfa-2a [Pegasys]
- Where
- 32 sites in United States, France and 2 more
- Volunteers
- 170 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
- Trial name
- NCT00004578
- Testing
- Lopinavir/Ritonavir, Lamivudine, Stavudine
- Where
- 10 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abbott
HIV-1 Infection
Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)
The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically…
- Trial name
- DRIVE-SHIFT (NCT02397096)
- Testing
- Doravirine, Tenofovir, Lamivudine, Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor, Baseline regimen of cobicistat-boosted elvitegravir
- Volunteers
- 673 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C
This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV)…
- Trial name
- NCT01500772
- Testing
- Alisporivir, Peginterferon alfa-2a, Ribavirin
- Where
- 60 sites in United States, Canada and 6 more
- Volunteers
- 6 people
- Sponsor
- Debiopharm International SA
COVID-19 SARS-CoV-2 Infection
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease.
- Trial name
- NCT06679140
- Testing
- ibuzatrelvir
- Where
- 256 sites in United States, Argentina and 17 more
- Volunteers
- 2,330 people
- Sponsor
- Pfizer
Alpha 1-Antitrypsin Deficiency
Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)
The purpose of this study is to evaluate the effects of weekly augmentation therapy with ARALAST Fraction IV-1 (Fr IV-1) on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor levels and other ELF analytes and to assess…
- Trial name
- NCT00396006
- Testing
- Alpha1-Proteinase Inhibitor
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 21 people
- Sponsor
- Baxalta now part of Shire
Sarcoma, Kaposi, HIV Infections
A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3
To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).
- Trial name
- NCT00002185
- Testing
- Nelfinavir mesylate
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Agouron Pharmaceuticals