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hepatitis b/protease

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Monovalent Recombinant COVID19 Vaccine

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Human infections with zoonotic coronaviruses including severe acute respiratory syndrome coronavirus (SARS CoV), Middle East respiratory syndrome-associated coronavirus (MERS CoV) and now 2019 SARS-CoV-2, all pose major human public health threats with high case fatality rates. The outbreak of

Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon

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Chronic delta hepatitis is a serious form of chronic liver disease caused by infection with the hepatitis D virus (HDV), a small RNA virus that requires farnesylation of its major structural protein (HDV antigen) for replication. Based on previous and ongoing clinical trials demonstrating

Impact of Different Integrase Inhibitor Based Regimen on Immune Activation Among HIV naïve Patient (INTATTI)

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INTRODUCTION AND BACKGROUND Combination antiretroviral therapy (cART) controls HIV-1 plasma viral load in most patients, leading to a reduction in morbidity and mortality [Egger M, BMJ 1997; Detels R, JAMA 1998]. Despite efficient treatment persistent low-level viral replication and immune

Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience

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The treatment of chronic Hepatitis C with combination directly acting antiviral agents (DAAs) represents a dramatic improvement over previous therapies in safety, tolerability and efficacy, but these therapies are not universally effective. Some patients fail to achieve sustained virologic response

Observational, Retrospective Analysis in HIV-1 Infected Patients. (ORASWIRAL)

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Adult, male and female HIV-1 infected subjects, who started an antiretroviral regimen of RALTEGRAVIR plus ABACAVIR and LAMIVUDINE after a different antiretroviral regimen. Subject Selection: Inclusion Criteria All consecutive patients fulfilling the following inclusion criteria will be considered: -

Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir

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Chronic delta hepatitis is a serious form of chronic liver disease caused by infection with the hepatitis D virus (HDV), a small RNA virus that requires farnesylation of its major structural protein (HDV antigen) for replication. We propose to treat 21 adult patients with chronic delta hepatitis

Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy

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Liver disease, especially viral hepatitis, is an important public health issue, which frequent leads to liver cirrhosis, hepatocellular carcinoma (HCC) and liver-related death. Around 340 to 400 million persons are infected with hepatitis B virus (HBV) and 130 to 210 million persons are infected

Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life Conditions

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In the last years, various clinical trials and studies have evaluated the incidence of hepatic toxicity (HT) associated with the commonly used antiretroviral drugs in the HIV/hepatitis C virus (HCV)-infected population. Unfortunately, clinical trials that compared hepatic safety of these

A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

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A5288 was an open-label phase IV, prospective interventional, strategy study in resource-limited settings (RLS) for HIV-1 infected participants with triple-class experience or resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-NRTIs (NNRTIs), and protease inhibitors (PIs) and who

Safety and Efficacy Study Comparing Raltegravir to a Protease Inhibitor in Treatment-naïve, HIV/Hepatitis C Drug Users

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Raltegravir is an HIV-1 integrase inhibitor that is currently licensed for use in treatment-experienced HIV-1 patients and recently approved for use in treatment-naïve patients. Recent data has shown that the virologic response in patients on raltegravir with no history of antiretroviral treatment

The St. Marys and The Mater Switch Study

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To assess the safety, changes in platelet reactivity, plasma cardiac biomarkers and metabolic parameters in HIV 1 infected subjects undergoing a switch in ART from a nucleoside containing regimen which includes abacavir and / or didanosine to a maraviroc containing regimen. 40 HIV-1 infected

An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects

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This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The study will have a screening visit, 3 treatment visits for pharmacokinetics (PK) sampling and a

A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults

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Background: Human papilloma virus (HPV) is one of the most common sexually transmitted diseases and a significant cause of cutaneous genital warts and anogenital cancer. Infection with high-risk, oncogenic HPV types, most commonly types 16 and 18, is associated with low and high-grade cervical

An Interaction Study to Assess Drug Levels in Healthy Adult Subjects

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This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The study will have a screening visit, 3 treatment visits for PK sampling and a follow-up visit. The

An Interaction Study to Assess Drug Levels in Healthy Adult Subjects

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This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The study will have a screening visit, 3 treatment visits for pharmacokinetics (PK) sampling and a
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