Search for a trial

A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial

PrimaryIn HCV-infected subjects who have previously been treated with MK-5172 and received at least one dose:1. To evaluate the durability of SVR in subjects who remained HCV RNA LLoQ (either TND or TDu) throughout the follow-up period of the…

A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment

The primary objective of this study is:- To evaluate the effect of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) on renal parameters at Week 24The secondary objectives of this study are:- To…

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 phase 1 open-label study to characterize the metabolism and excretion of a single dose of radiolabeled AL-335 administered in combination with Odalasvir and Simeprevir and administered alone in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent AL-335 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). AL-335 to be administered will be labeled with 14-…

Immune phenotyping in chronic HCV patients treated with Sofosbuvir and Daclatasvir combination for 12 or 24 weeks * SODA study

Primary objectiveThe primary objective for this study is to analyse the impact of inhibition of viral replication by interferon-free therapy consisting of Sofosbuvir and Daclatasvir (±Ribavirin) on the phenotype and function of the innate immune…

Ledipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis. HepNed-001 study

To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotype 4 patients without cirrhosis.

Once daily DArunavir/ritonavir in HIV-infected children 6-12 years old: a PHarmacokiNEtic validation of model-based dosing recommendations (DAPHNE)

To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old

Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of ACUTE hepatitis C genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2)

The goal of this study is to document the efficacy of a shortened 8-week therapy with grazoprevir and elbasvir in patients with acute HCV genotype 1 or 4 infection.

An Open-Label Study of GS-7977+ Ribavirin with or without Peginterferon Alfa-2a in Subjects with Chronic HCV Infection who Participated in Prior Gilead HCV Studies

The primary objectives of this study are:* To determine the efficacy of GS-7977 + RBV with or without Peginterferon alfa-2a (PEG) as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (…

Efficacy of 12 week boceprevir in addition to standard of care therapy consisting of peginterferon-alpha-2b and ribavirin for the treatment of acute HCV genotype 1 in HIV co-infected patients. A proof of concept feasibility clinical trial.

Document the efficacy and tolerability of 12 weeks of Boceprevir (Victrelis®) therapy in addition to standard of care (SOC) therapy consisting of weekly weight based peginterferon alfa-2b (Pegintron®) SC and ribavirin PO BID, for the treatment of…

MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV;Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…

A pilot study on the efficacy and pharmacokinetics of a switch from nevirapine with emtricitabine, tenofovir or lamivudine, tenofovir or lamivudine, zidovudine to rilpivirine with emtricitabine, tenofovir in virologically suppressed HIV-1 infected patients.

Primary objective:To evaluate the efficacy of a RPV based HAART in patients that switch from NVP with FTC, TDF or lamivudine (3TC), TDF or 3TC, zidovudine (ZDV) to RPV/FTC/TDF.Secondary objectives:To measure the impact (strength and duration) of NVP…

Treatment adherence in patients treated with telaprevir for a chronic hepatitis C genotype 1 infection: an observational study

Primary objective To establish the mean level of adherence to telaprevir in chronic hepatitis C patients during treatment with telaprevir, pegylated-interferon-alfa and ribavirin.Secondary objectives• To establish the mean level of adherence to…

A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-8408 in Subjects with Hepatitis C Infection

-To identify a safe dose of MK-8408 in HCV infected patients that mediates a 3Log10 reduction-To evaluate safety and tolerability of MK-8408 administered for 5 consecutive days-To evaluate the plasma pharmacokinetic profile of multiple oral doses of…

An Open-Label, Single Dose, 4-Period, 4-Way Randomized Crossover Study to Evaluate the Pharmacokinetics of Preliminary Market Formulations of MK-8408 in Healthy Adult Subjects.

Primary:1. To assess the pharmacokinetic profiles following single dose administration of MK-8408 administered as a PMF1 tablet by means of AUC0-*, AUClast, AUC0-24, Cmax, C24, tmax, and t* under fed conditions, following a high fat meal. 2. To…

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-…

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…

An open-label trial with TMC278 25 mg q.d. in combination with a
background regimen containing 2 nucleoside/nucleotide reverse
transcriptase inhibitors in HIV-1 infected subjects, who participated in
TMC278 clinical trials.

Primary ObjectiveThe primary objective of the trial is to provide continued access to TMC278 for subjects who were randomized andtreated with TMC278 in the Phase IIb (e.g., TMC278-C204 [C204]) or Phase III trials (e.g., TMC278-TiDP6-C209[ECHO] and…

A ONE-WAY DRUG DRUG INTERACTION STUDY TO ASSESS THE EFFECT OF EFAVIRENZ ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF BMS-790052 IN HEALTHY SUBJECTS

Primary: To assess the effect of multiple oral doses of 600 mg efavirenz once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary: To assess the safety of multiple oral doses of BMS-790052 given alone and together with…

An Open-Label Two-Way Drug-Drug Interaction Study to Assess the Effect of Tenofovir on the Pharmacokinetics of BMS-790052 and the Effect of BMS-790052 on the Pharmacokinetics of Tenofovir in Healthy Subjects

The purpose of the study is to investigate the effect of multiple oral doses of Tenofovir on how quickly and to what extent BMS-790052 is absorbed and eliminated from the body and the effect of multiple oral doses of BMS-790052 on how quickly and to…