Clinical trials: Treatment naïve
Infection, Human Immunodeficiency Virus, HIV Infections
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (Tenofovir…
- Trial name
- NCT02831673
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- Where
- 90 sites in United States, Argentina and 16 more
- Volunteers
- 719 people
- Sponsor
- ViiV Healthcare
Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
This phase II trial studies how well pembrolizumab works in treating patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer that have not received prior tyrosine kinase inhibitor therapy and has…
- Conditions
- Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- Trial name
- NCT02879994
- Testing
- Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Visceral Leishmaniasis
A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar
The purpose of this study is: 1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or…
- Trial name
- NCT00497601
- Testing
- Amphotericin B fat emulsion in visceral leishmaniasis, Amphotericin B fat emulsion, Amphotericin B in fat emulsion
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Banaras Hindu University
Crohn Disease, Colitis, Ulcerative
A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD)
The purpose of this non-interventional study (NIS) study is to assess further knowledge on the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in participants with CD and UC naive to biologics.
- Conditions
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
- Trial name
- CHRONOS (NCT02986724)
- Where
- Austria
- Volunteers
- 60 people
- Sponsor
- Takeda
Pompe Disease (Infantile-Onset), Glycogen Storage Disease Type II (GSD II)
A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease
A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who had been diagnosed with infantile-onset Pompe disease.
- Conditions
- Pompe Disease (Infantile-Onset), Glycogen Storage Disease Type II (GSD II), Glycogenosis 2, Acid Maltase Deficiency
- Trial name
- NCT01597596
- Testing
- alglucosidase alfa
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 4 people
- Sponsor
- Genzyme, a Sanofi Company
Acute Myeloid Leukemia, EBV-Positive Neoplastic Cells Present
Laboratory-Treated (Central Memory/Naive) CD8+ T Cells in Treating Patients With Newly Diagnosed or Relapsed Acute Myeloid Leukemia
This phase I/II trial studies the side effects of laboratory-treated (central memory/naive) cluster of differentiation 8+ T cells (autologous Wilms tumor [WT]1-T cell receptor [TCRc]4 gene-transduced CD8-positive central memory…
- Conditions
- Acute Myeloid Leukemia, EBV-Positive Neoplastic Cells Present, HLA-A*0201 Positive Cells Present, Blasts Under 5 Percent of Bone Marrow Nucleated Cells
- Trial name
- NCT02770820
- Testing
- Aldesleukin, Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Fred Hutchinson Cancer Center
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
- Trial name
- NCT02068222
- Testing
- ABT-450/ritonavir (r), ABT-530, Ribavirin (RBV)
- Volunteers
- 10 people
- Sponsor
- AbbVie
Non-small Cell Lung Cancer
mil60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer
This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in…
- Trial name
- NCT03196986
- Testing
- mil60, Bevacizumab
- Where
- 2 sites in China
- Volunteers
- 517 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Head and Neck Squamous Cell Carcinoma
A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).
This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies.
- Trial name
- NCT03022409
- Testing
- Ceralasertib, Olaparib
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 21 people
- Sponsor
- AstraZeneca
HIV Infections
Durability of Nevirapine-Based Antiretroviral Regimen
Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its…
- Trial name
- NCT00703898
- Testing
- nevirapine
- Where
- Thailand
- Volunteers
- 140 people
- Sponsor
- Bamrasnaradura Infectious Diseases Institute
HIV-1/HBV Co-Infection
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate…
- Trial name
- Alliance (NCT03547908)
- Testing
- B/F/TAF, DTG, F/TDF
- Where
- 69 sites in United States, China and 12 more
- Volunteers
- 244 people
- Sponsor
- Gilead Sciences
HIV Infection, Hepatitis C
A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects
The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir)…
- Trial name
- NCT00121017
- Testing
- Kaletra (lopinavir/ritonavir), Sustiva (efavirenz), Truvada (emtricitabine/tenofovir disoproxil fumarate)
- Volunteers
- 200 people
- Sponsor
- Abbott
HIV Infections
Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)
The goal of this study is to analyze in treatment-naïve HIV patients the antiviral activity, using a test and treat strategy, in real life of BIC/FTC/TAF.
- Trial name
- BIC-NOW (NCT06177574)
- Testing
- BIC/FTC/TAF
- Where
- 15 sites in Spain
- Volunteers
- 208 people
- Sponsor
- Carmen Hidalgo Tenorio
Chronic Hepatitis C Infection
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.
- Trial name
- MALACHITE 1 (NCT01854697)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin, Telaprevir
- Volunteers
- 311 people
- Sponsor
- AbbVie
AIDS, AIDS Vaccines
Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects
The purpose of this study is to investigate a combined set of parameters deemed to impact the quality of CMI analyses in terms of the proportion of viable lymphocytes in antiretroviral therapy-naïve HIV-1 infected subjects.
- Trial name
- NCT01610427
- Testing
- Blood sample collection
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
- Trial name
- NCT00412750
- Testing
- Telbivudine (LdT), peginterferon alpha-2a
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Novartis
Chronic Hepatitis C Virus
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in…
- Trial name
- NCT01726517
- Testing
- LDV/SOF, RBV
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4
To evaluate the safety and efficacy of a daily, fixed-dose, 8-week course combination of Elbasvir/Grazoprevir in treatment-naïve, non-cirrhotic patients who are mono-infected with hepatitis C, genotype 4.
- Trial name
- ELEGANT-4 (NCT03578640)
- Testing
- Elbasvir, Grazoprevir 50-100Mg Oral Tablet
- Where
- Saudi Arabia
- Volunteers
- 30 people
- Sponsor
- King Fahad Medical City
Critically Ill, Hyperglycemia
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2
The Purpose of this study is to: 1. Introduce the refined, validated, and safe computerized bedside decision support tool for blood glucose management in critically ill adult and pediatric ICU patients that was studied in Phase 1…
- Trial name
- NCT00654797
- Testing
- glucose control with computer generated recommendations
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Intermountain Health Care, Inc.
HIV Infections
Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an…
- Trial name
- INDUMA (NCT00207142)
- Testing
- Atazanavir + 2 NRTIs, Atazanavir + Ritonavir + 2 NRTIs
- Where
- 27 sites in Estonia, France and 8 more
- Volunteers
- 252 people
- Sponsor
- Bristol-Myers Squibb