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A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

EARLY ORAL SWITCH THERAPY IN LOW-RISK
STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTION

The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…

Donor feces infusion for first episode of Clostridium difficile infection in patients at risk for recurrent infection

The primary objective of this study is to investigate whether FMT after antibiotic therapy is more effective than conventionalantibiotic therapy alone in patients with a first episode of CDI.

A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment

Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…

A Kaletra ONCE daily Randomised Trial of the
pharmacokinetics, safety and efficacy of twice-daily
versus once-daily lopinavir/ritonavir tablets dosed by
weight as part of combination antiretroviral therapy in
HIV-1 infected children (PENTA 18).

Evaluating the current dosing guidelines in children taking the half-strength paediatric tablets will provide reassurance that the recommended lopinavir/ritonavir dose provides adequate drug exposure and maintains efficacy.This trial will evaluate…

A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy-Experienced Adults.

Primary: Antiviral efficacy after 48 weeks of treatment. Secundary: Antiviral efficacy after 24 weeks, safety and tolerability, resistance development, PK, incidence of HIV-associated conditions, gender-, race-, and/or HIV-1 subtype on response to…

A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old men.

This study is designed to evaluate the immunogenicity and tolerability of V503 in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men, 16 to 26 years of age. The safety and immunogenicity data will be used to bridge GARDASIL®…

A Phase 3, Open Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically Suppressed, HIV 1 Positive Subjects

The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, and GT6 Infection

Primary Objective(s) & HypothesisObjective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy…

An open-label randomised two-year trial comparing two first-line regimens in HIV-infected antiretroviral naïve subjects:
darunavir/r + tenofovir/emtricitabine vs. darunavir/r + raltegravir

Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…

An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension

The primary objective of this study is to assess the comparative safety and efficacy ofAztreonam Lysine for Inhalation (AZLI) and Tobramycin Nebuliser Solution (TNS) in adultand pediatric cystic fibrosis (CF) patients aged 6 years or older with…

Preventive Antibiotics in Stroke Study

To investigate whether preventive use of the antibiotic ceftriaxone improves functional health outcomes in patients with stroke by preventing infection. This will be done in a large multi-centre randomized controlled trial. Within this trial we will…

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

* To demonstrate efficacy of the candidate vaccine in the prevention of (1) persistent infection (6-month definition) with HPV-16 or HPV-18 (by polymerase chain reaction [PCR]) and/or (2) histopathologically-confirmed CIN1+ associated with HPV-16 or…

High-dose versus standard-dose weight-based ribavirin in combination with peginterferon alfa-2a for patients infected with hepatitis C virus genotype 1 or 4

To investigate if high-dose ribavirin in combination with peginterferon alfa-2a can improve outcome in treatment naïve hepatitis C patients with genotype 1 or 4 and a high viral load (>400.000 IU/ml).

A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients with Chronic Genotype 2 or 3 HCV Infection

Primary:* To determine the efficacy of PSI-7977 in combination with RBV administered for 12 weeks compared with PEG/RBV administered for 24 weeks in treatment-naïve patients with HCV genotype 2 or 3 as assessed by the rate of SVR12 (HCV RNA of…

NAI114373: A Phase III international, randomized, doubleblind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza (NAI114373)

Primary: To assess the efficacy of treatment with 300 mg or 600 mg of intravenous (IV) zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily on time to clinical response. Secondary: reduction in viral load from nasopharyngeal swabs…

A phase 3, randomized, double-blind study to evaluate the safety and efficacy of GS-9350-boosted Atazanavir versus Ritonavir-boosted Atazanavir each administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naive adults.

The primary objective of this study is:To evaluate the efficacy of a regimen containing GS 9350-boosted Atazanavir versus ritonavir-boosted atazanavir each administered with emtricitabine/tenofovir disoproxil fumarate in HIV 1 infected,…

A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects (ING114467)

Primary: Antiviral efficacy of dolutagravir in combination with Kivexa (abacavir en lamivudine) after 48 weeks of treatment in comparison with Atripla (tenofovir, emtricitabine and efavirenz). Secondary: Antiviral efficacy after 96 and 144 weeks,…

A Phase 3, Randomized, Double-Blind Study to Evaluate the
Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/
Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/
Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1
Positive, Antiretroviral Treatment- Naïve Adults

The primary objective of this study is:• To evaluate the efficacy of a single-tablet regimen (STR) containingelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STRcontaining elvitegravir/cobicistat/emtricitabine/…

A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C who Achieve an Extended Rapid Viral Response (eRVR) While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

Primary:To estimate the difference in SVR rates between T12/PR24 and T12/PR48 treatment regimens in subjects who achieve eRVR.Secondary:To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naïve subjects with…