
Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients...
BK Virus InfectionThis study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection. The study will also determine if immune monitoring tests can detect an association between BK virus infection and transplant rejection episodes, based on the specific BKV infection treatment regimen. The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and tacrolimus + prednisone in patients who have undergone renal transplantation and have active BKV infections.

A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection...
Hepatitis BDose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are required periodically through day 43. Subjects with sustained reductions in HbsAg will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments

Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic...
Hepatitis CThis is a research study to evaluate the safety, tolerability and anti-viral activity of GS-9669 in patients with Hepatitis C infection.

A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma
Nasopharyngeal CancerEpstein Barr Virus InfectionsThis clinical study is looking at a vaccine called MVA-EBNA1/LMP2. This is a new vaccine that has already been studied in small number of cancer patients. The vaccine is designed to boost a patient's immunity against a common virus. The virus is called Epstein Barr virus or EBV. EBV is sometimes found inside cancer cells and is commonly found in nasopharyngeal cancer cells.

A Study of Balapiravir in Patients With Dengue Virus Infection
DengueThis randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is <200

Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency...
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)Human Immunodeficiency Virus InfectionsThis study is a Phase 2/3, multicenter, double-blind, randomized, parallel-group, placebo-controlled, dose-finding trial of Serostim® (mammalian cell-derived recombinant human growth hormone, r-hGH) versus placebo in subjects with human immunodeficiency virus-associated adipose tissue redistribution syndrome (HARS). The primary study objective is to determine whether Serostim® treatment reduces adipose tissue maldistribution more effectively than placebo. The primary co-endpoints are derived from measures of visceral adipose tissue assessed by computerized tomography (CT) and the ratio of trunk; and limb fat assessed by dual-energy X-Ray absorptiometry (DXA) scans. Anthropometric measures, physical exams, quality of life assessments, serial photographs, and various laboratory measures will be used to address secondary objectives. These secondary objectives relate to the impact of Serostim® on Physician and subject assessments of change in body shape, health-related quality of life, attitude towards medication compliance, metabolic markers, fat redistribution, and safety. On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive daily Serostim®, Serostim® and placebo given on alternate days, or daily placebo. Serostim® doses will be based on body weight, with a maximum dose of 4 milligram (mg). Therapy will continue for 12 weeks. Treatment will then be altered and the new treatment will be continued through Week 24. Interim Study Visits will be required at Weeks 2 and 4 (Treatment Period 1) and at Weeks 14 and 16 (Treatment Period 2). Subjects will be offered to be enrolled into a maintenance Protocol (Study 23056) at Week 24.

Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.
Hepatitis CThe purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in patients with chronic hepatitis C after liver transplantation. The only approved drugs for treatment of hepatitis C are pegylated interferon and ribavirin.

Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients
Respiratory Syncytial Virus InfectionsThe purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients.

An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients...
HIV InfectionsCytopeniasTo determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.

Clinical Study of Efficacy and Safety of Raphamin in the Treatment of ARVI in Children 12-18 Years...
Acute Respiratory Viral InfectionThe multicenter double-blind placebo-controlled randomized in parallel-group. The objective of this study is to evaluate efficacy and safety of Raphamin in the treatment of acute respiratory viral infection (ARVI) in children aged 12-18 years old.