Clinical trials: Treatment Naive
Asthma
BI 671800 ED in Steroid-naive Asthmatic Patients
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
- Trial name
- NCT01092143
- Testing
- BI 671800, Fluticasone propionate
- Where
- 92 sites in United States, Australia and 8 more
- Volunteers
- 389 people
- Sponsor
- Boehringer Ingelheim
Chronic Hepatitis C, Hepatitis C (HCV)
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults…
- Conditions
- Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1a
- Trial name
- NCT02476617
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Volunteers
- 25 people
- Sponsor
- AbbVie
Diabetic Retinopathy
A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic…
- Trial name
- CANBERRA (NCT04265261)
- Testing
- RG7774
- Where
- 68 sites in United States, Australia and 5 more
- Volunteers
- 139 people
- Sponsor
- Hoffmann-La Roche
Hepatitis, HIV/AIDS
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
Background: Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN and ribavirin. However, this treatment is not very effective in people with a serious type of HCV (HCV genotype 1) and also in…
- Trial name
- NCT01443923
- Testing
- Boceprevir, Peg-Interferon-alfa 2B, Ribavirin
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-associated Cognitive Impairment, HIV Infections
Minocycline for HIV+ Cognitive Impairment in Uganda
Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive impairment in Uganda.
- Trial name
- NCT00855062
- Testing
- minocycline
- Where
- Uganda
- Volunteers
- 73 people
- Sponsor
- Johns Hopkins University
Hepatitis C Virus
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than…
- Trial name
- HEPCAT (NCT01125189)
- Testing
- Daclatasvir, peg-interferon alfa-2a, ribavirin
- Where
- 64 sites in United States, Australia and 9 more
- Volunteers
- 558 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve…
- Trial name
- NCT01579474
- Testing
- BI 201335 high dose, BI 201335 low dose
- Where
- 24 sites in Japan
- Volunteers
- 131 people
- Sponsor
- Boehringer Ingelheim
Multiple Myeloma
Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185)
The purpose of this study is to compare the efficacy of lenalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of lenalidomide and low dose dexamethasone without pembrolizumab in terms of progression-free…
- Trial name
- NCT02579863
- Testing
- Pembrolizumab, Lenalidomide, Dexamethasone
- Volunteers
- 310 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).
- Trial name
- NCT01448044
- Testing
- BMS-790052 (NS5A Replication Complex Inhibitor), Pegylated-interferon alfa 2a, Ribavirin
- Where
- 26 sites in United States, France and 5 more
- Volunteers
- 152 people
- Sponsor
- Bristol-Myers Squibb
HIV-1 Infection
Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted…
- Trial name
- NCT00892437
- Testing
- COBI, RTV, ATV
- Where
- 31 sites in United States
- Volunteers
- 85 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C, Genotype 1
Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.
- Trial name
- OPTIMAL (NCT01405027)
- Testing
- Educational Intervention, Patient education and management skills training
- Where
- 43 sites in United States
- Volunteers
- 197 people
- Sponsor
- Chronic Liver Disease Foundation
HIV
Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment
The purpose of this research study is to compare changes in triglyceride and other lipids (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir 800/100 mg once daily versus…
- Trial name
- NCT00757783
- Testing
- ritonavir, darunavir, emtricitabine [FTC]/tenofovir [TDF]
- Where
- 15 sites in United States
- Volunteers
- 68 people
- Sponsor
- Tibotec, Inc
HIV-1-infection
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3 Protocol Number: FH-57 Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4…
- Trial name
- DOLCE (NCT04880395)
- Testing
- Intervention Arm: dolutegravir/lamivudine, Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
- Where
- 11 sites in Argentina, Brazil
- Volunteers
- 265 people
- Sponsor
- Fundación Huésped
Chronic Hepatitis C, Genotype 4 Chronic Hepatitis C
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control.
- Trial name
- NCT02250807
- Testing
- Simeprevir, Sofosbuvir
- Where
- 6 sites in Spain
- Volunteers
- 40 people
- Sponsor
- Janssen R&D Ireland
Type 2 Spinal Muscular Atrophy
Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)
This was a Phase III multi-center, single dose (1.2 x 10^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never…
- Trial name
- STEER (NCT05089656)
- Testing
- OAV101
- Where
- 42 sites in United States, Brazil and 11 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Human Immunodeficiency Virus Type 1
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
- Trial name
- NCT00110305
- Testing
- TMC278 25 mg, TMC278 75 mg, TMC278 150 mg
- Where
- 40 sites in United States, Argentina and 12 more
- Volunteers
- 368 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients.
- Trial name
- NCT00435929
- Testing
- Ritonavir, saquinavir [Invirase]
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r)
This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then de-intensification management strategy in adolescents with mild immunosuppression and compare changes in CD4% from baseline to week 48 and then…
- Trial name
- NCT00491556
- Testing
- Early Initiation of Highly Active Anti-Retroviral Therapy, Standard Care
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 102 people
- Sponsor
- University of North Carolina, Chapel Hill
Hepatitis C, Chronic
A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1…
- Trial name
- NCT01292239
- Testing
- TMC435, Peginterferon alfa-2a (pegIFN alfa-2a), Ribavirin (RBV)
- Where
- 28 sites in Japan
- Volunteers
- 183 people
- Sponsor
- Janssen Pharmaceutical K.K.
HIV Infections
BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada
The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV.
- Trial name
- NCT00272779
- Testing
- ATV, RTV, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- 79 sites in United States, Argentina and 27 more
- Volunteers
- 1,057 people
- Sponsor
- Bristol-Myers Squibb