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A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

The primary objective of this Registry is:• To evaluate HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral containing regimen…

Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men

The objective of the current proposal is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and intra-anal high-grade, HPV16 positive AIN, who failed on…

A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection

The primary objective of this Registry is:*To evaluate the long term effects of Hepatitis B Virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144 The secondary objective of this Registry is :*To evaluate the long…

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…

Immunogenicity and safety of an adjuvant hepatitis B vaccine (fendrix) compared to Engerix in non-responding HIV-infected patients

To study the immunogenicity and safety of adjuvanrt hepatitis B vaccin (Fendrix) compared to double-dosage of Engerix vaccination in HIV infected patients, previously failing HBV vaccinations.

TREATMENT WITH CMV PP65 SPECIFIC T CELLS GENERATED BY USE OF A CMV PP65 PROTEIN-SPANNING PEPTIDE POOL IN PATIENTS WITH CMV REACTIVATION OR CMV DISEASE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION

• To assess the feasibility, tolerability and safety of administration of donor or patient derived CMV pp65-specific T cells in patients with CMV reactivation or CMV disease after alloSCT.• To determine the presence of CMV specific T cells at…

A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylaat Administered with Ribavirin

- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…

An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals' candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older.

The purpose of this long-term follow-up (LTFU) study (ZOSTER-024) is to evaluate the cell-mediated and humoral immune responses of subjects who previously participated in study ZOSTER-003 and who were in the group receiving 2 doses of 50µg gE/AS01B…

An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon *-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study

The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study…

The role of paroxetine in patients taking telaprevir-based HCV therapy: lack of a drug-drug interaction? (ROLEX)

Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…

An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

Primary ObjectiveTo assess the efficacy based on the proportion of subjects with SVR12, defined as HCV RNAgenotype 1 who are prior non-responders to pegIFNα-2a/RBV.Secondary Objectives• To assess efficacy, as determined by the proportion of subjects…

Pharmacokinetic and safety pilotstudy of RAltegravir and atazanavir in a once DAily dose regimen in HIV-1 in-fected patients (PRADA)

Primary: To compare the pharmacokinetics of raltegravir 400 mg twice daily vs. ralte-gravir 800 mg once daily (QD) by intrasubject comparison. Secondary: To determine the efficacy of an antiretroviral regimen consisting of raltegravir 800mg QD,…

A Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin with Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects

Primary: To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy(i.e. amantadine and ribavirin co-administered with oseltamivir) compared to oseltamivirmonotherapy in immunocompromised subjects diagnosed with Influenza…

Achieving appropriate exposuRe to RIBAvirin after a dose advise based on an abbreviated AUC of a first dose of ribavirin (ARRIBA)

Primary objective: To evaluate if adequate exposure to ribavirin can be achieved after a dose adjustment based on the AUC0-4h from a first dose of ribavirin.Secondary:• To evaluate how many patients need a dose adjustment to achieve adequate…

A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C (CHC) Infected With Genotype 1

The primary objective of this study is to evaluate the efficacy of SCH 503034800 mg TID PO in combination with PegIntron 1.5 *g/kg QW SC plus ribavirin (800 - 1400 mg/day) in previously untreated adult chronic hepatitis C (CHC) subjects infected…

Immunogenicity and safety of intradermal injection of reduced dose Inactivated Poliovirus vaccine (IPV) with a jet injector in healthy adults

The primary objective of this trial is to compare the immunogenicity and safety (local and systemic reactions) of a reduced dose intradermal IPV (NVI) booster vaccination administered with a jet injector to a standard full dose intramuscular IPV (…

A Phase II, open-label trial to evaluate the safety, tolerability and
antiviral activity of TMC125 in antiretroviral experienced HIV-1
infected children and adolescents.

This study is a Phase II, non-randomized, open label trial to evaluate Safety and Antiviral activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents.

A Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106 Who did not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

To provide access to a telaprevir-based treatment to subjects of the Control Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate response to treatment (according to treatment stopping rules). Safety, tolerability, and HCV…

A Phase IIa randomized, open-label study of telaprevir (VX-950) administered every 12 or every 8 hours in combination with either Peg-IFN alfa2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment naive subjects with chronic genotype 1 hepatitis C infection.

The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…

A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

The primary objective of this Registry is:• To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored hepatitis C study.The secondary objectives of this Registry are:• To determine whether subsequent…