Product Name: Fuzeon [enfuvirtide]
Date of Report: 9/19/2001
Phase: II
A Controlled Phase II Trial Assessing 3 Doses of T-20 in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-Infected Adults
Product Name: Fuzeon [enfuvirtide]
Date of Report: 10/8/2001
Phase: II
A Phase II Rollover Protocol for HIV-Infected Adults with Prior Fuzeon Treatment
Product Name: Fuzeon [enfuvirtide]
Date of Report: 10/19/2001
Phase: II
Tolerance and Pharmacokinetics (PK) of Carbonate and TRIS Buffer High-Strength (100mg/mL) Formulations of T 20/Ro29-9800 (HIV 1 Fusion Inhibitor) Compared to the Current Carbonate Formulation (50mg/mL), Each at Doses of 75 and 100mg bid, in Treatment-Experienced HIV-Infected Patients
Product Name: Fuzeon [enfuvirtide]
Date of Report: 6/18/2002
Phase: II
Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Antiretroviral Regimen in HIV Infected Children and Adolescents
Product Name: Fuzeon [enfuvirtide]
Date of Report: 6/27/2002
Phase: III
A Phase III, Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20/Ro 29-9800 (HIV-1 Fusion Inhibitor) in Combination with an Optimized Background Regimen Versus Optimized Background Regimen Alone in Patients with Prior Experience and/or Prior Documented Resistance to Each of the 3 Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-nucleoside Reverse Transcriptase, and Protease Inhibitors)
Product Name: Fuzeon [enfuvirtide]
Date of Report: 7/30/2002
Phase: III
A Phase III, Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20/Ro 29-9800 (HIV-1 Fusion Inhibitor) in Combination with an Optimized Background Regimen Versus Optimized Background Regimen Alone in Patients with Prior Experience and/or Prior Documented Resistance to Each of the 3 Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-nucleoside Reverse Transcriptase, and Protease Inhibitors)
Product Name: Fuzeon [enfuvirtide]
Date of Report: 8/15/2003
Phase: III
A Phase III, Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T 20/Ro 29 9800 (enfuvirtide; HIV 1 Fusion Inhibitor) in Combination with an Optimized Background Regimen versus Optimized Background Regimen Alone in Patients with Prior Experience and/or Prior Documented Resistance to Each of the 3 Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-nucleoside Reverse Transcriptase, and Protease Inhibitors)
Product Name: Fuzeon [enfuvirtide]
Date of Report: 8/15/2003
Phase: III
A Phase III, Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T 20/Ro 29 9800 (enfuvirtide; HIV 1 Fusion Inhibitor) in Combination with an Optimized Background Regimen versus Optimized Background Regimen Alone in Patients with Prior Experience and/or Prior Documented Resistance to Each of the 3 Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-nucleoside Reverse Transcriptase, and Protease Inhibitors)
Product Name: Fuzeon [enfuvirtide]
Date of Report: 6/21/2004
Phase: III
Multicenter, open-label, early-access program of Fuzeon (enfuvirtide) (T-20/Ro 29-9800, HIV-1 fusion inhibitor) in combination with free choice antiretroviral regimen to assess serious adverse events, serious AIDS-defining events, and tolerability in patients with advanced HIV infection
Product Name: Fuzeon [enfuvirtide]
Date of Report: 4/11/2005
Phase: IV
An open-label, randomized, crossover study in HIV-positive subjects to determine and compare the single-dose pharmacokinetics of enfuvirtide (Fuzeon) after a single 90 mg sc administration with the Biojector 2000 Needle-Free Injection System and a 27G ½-inch (12.7 mm) needle/syringe
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: III
Injection Site Reaction Sub-study of Fuzeon
Product Name: Fuzeon [enfuvirtide]
Date of Report: 6/1/2005
Phase: III
A phase 3, open-label, randomized, active-controlled study assessing the efficacy and safety of T20/RO29-9800 (enfuvirtide [ENF]; HIV-1 Fusion Inhibitor) in combination with an optimized background regimen versus optimum background regimen alone in patients with prior experience and/or prior documented resistance to each of the three classes of approved antiretrovirals (nucleoside reverse transcriptase, non-nucleoside reverse transcriptase, and protease inhibitors).
Product Name: Fuzeon [enfuvirtide]
Date of Report: 6/1/2005
Phase: III
A phase 3, open-label, randomized, active-controlled study assessing the efficacy and safety of T20/RO29-9800 (enfuvirtide [ENF]; HIV-1 Fusion Inhibitor) in combination with an optimized background regimen versus optimum background regimen alone in patients with prior experience and/or prior documented resistance to each of the three classes of approved antiretrovirals (nucleoside reverse transcriptase, non-nucleoside reverse transcriptase, and protease inhibitors).
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: III
Open-label, randomised and multi-center study evaluating the efficacy and safety of an optimised background antiretroviral regimen (OB) compared to OB associated with enfuvirtide in previously treated HIV-1 infected patients in virological success after a 28-week induction treatment with enfuvirtide plus OB
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: II
A Study of the Effect of Fuzeon (Enfuvirtide)-Based Therapy on Viral Load in HIV-Positive, Treatment-Naïve Patients
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: IV
A Study of Fuzeon (Enfuvirtide) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
Product Name: Fuzeon [enfuvirtide]
Date of Report: 11/1/2005
Phase: III
A phase III, open-label, uncontrolled, ‘roll over’ safety study of T-20/RO 29-9800 (HIV-1 fusion inhibitor) in combination with free choice of background antiretrovirals, in patients who have participated in prior T-20 clinical studies.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 11/1/2005
Phase: III
A phase III, open-label, safety study of enfuvirtide (HIV-1 fusion inhibitor) in combination with oral antiretrovirals in patients who are unable to construct a viable regimen.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 3/1/2006
Phase: IV
Prospective, open-label, multicenter, cohort study to assess HIV-1 patient QUAlity of LIfe and Tolerability after administration of Enfuvirtide-containing HAART (QUALITE study).
Product Name: Fuzeon [enfuvirtide]
Date of Report: 3/1/2006
Phase: IV
A 48-week, randomized, open-label, multicenter, prospective study comparing treatment with double-boosted saquinavir mesylate + lopinavir/ritonavir in combination with ENfuvirtide HAART versus double-boosted saquinavir mesylate + lopinavir/ritonavir + multiple Nucleoside Combination to evaluate Efficacy in HIV-1 positive patients. (ENHANCE study).
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: IV
OPTIONS Study: A Study of Three Delivery Mechanisms for Fuzeon.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 6/1/2006
Phase: IV
Single-dose study of pharmacokinetics of enfuvirtide (FUZEON, T20/RO29-9800) in HIV-1 infected subjects with renal impairment.
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: IV
A Study of Fuzeon (Enfuvirtide) in Patients With Advanced HIV Infection.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 8/1/2006
Phase: II
A phase II open-label, randomized, active-controlled study comparing the efficacy and safety of once daily enfuvirtide dosing versus the currently recommended twice daily dosing in HIV-1 infected treatment-experienced patients.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 11/1/2006
Phase: IV
A randomized, open-label, two-way, crossover study to assess the tolerability of the B2000 needle-free injection device (NFID) for administration of enfuvirtide (ENF).
Product Name: Fuzeon [enfuvirtide]
Date of Report: 1/1/2007
Phase: IV
Multicenter open-label early access program of Enfuvirtide (T-20, HIV-1 Fusion Inhibitor) in combination with free choice antiviral regimen in patients with advanced HIV-infection.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 4/2/2007
Phase: IV
A 24 week, open label, single arm study to evaluate the safety and efficacy of switching a toxicity causing antiretroviral (ARV) to enfuvirtide (ENF) and to assess resolution or improvement of ARV toxicities in patients with current, historical treatment-limiting toxicities.
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: IV
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 6/1/2007
Phase: IV
Fuzeon® Biojector® 2000 Open-Label Safety Study (BOSS).
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: IV
AMICI Study: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 9/3/2007
Phase: IV
A multicenter, open-label study evaluating the safety and efficacy of a new protease inhibitor (Darunavir) with Fuzeon (enfuvirtide) plus background antiretroviral regimen in HIV-1 infected, triple-class treatment experienced patients (BLQ Study).
Product Name: Fuzeon [enfuvirtide]
Date of Report: To be Published
Phase: II
INNOVE Study:A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients WIth Virological Failure.
Product Name: Fuzeon [enfuvirtide]
Date of Report: 4/1/2008
Phase: IV
A Phase IIIb/IV randomized, controlled study evaluating an intensification treatment strategy of adding enfuvirtide (ENF) to an oral Highly Active AntiRetroviral Therapy (HAART) in treatment experienced patients (INTENSE Study).
Product Name: Invirase [saquinavir]
Date of Report: To be Published
Phase: IV
ESPrES 500 Study: A Study to Evaluate the Safety of a New Tablet Formulation of Boosted Saquinavir in HIV-1 Infected Patients.
Product Name: Invirase [saquinavir]
Date of Report: To be Published
Phase: I
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
Product Name: Invirase [saquinavir]
Date of Report: 1/9/2008
Phase: IV
A 48-week, randomized, open-label, 2-arm study to compare the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naive HIV-1 infected patients (Gemini Study)
Product Name: Invirase [saquinavir]
Date of Report: To be Published
Phase: II
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
Product Name: Viracept [nelfinavir]
Date of Report: 7/1/2003
Phase: III
Investigation of the gastrointestinal tolerability of a new Roche 625 mg formulation of Viracept (nelfinavir) in subjects with HIV-1 infection.
Product Name: Viracept [nelfinavir]
Date of Report: 10/27/2005
Phase: II
Open, multicenter, randomized, treatment simplification study to evaluate the pharmacological efficacy and safety of a nelfinavir-ritonavir combination one/day (OD) in comparison to nelfinavir twice/day (BID), using the new formulation of nelfinavir 625 mg in HIV-1 patients pretreated with nelfinavir 250 mg.
Product Name: Viracept [nelfinavir]
Date of Report: To be Published
Phase: IV
A Study of the Safety of Viracept (Nelfinavir) in an Expanded Access Program in HIV-1 Positive Women Who are Pregnant or Who Want to Become Pregnant
Product Name: Viracept [nelfinavir]
Date of Report: 5/1/2006
Phase: III
Expanded access program of nelfinavir mesylate new formulation 625 mg in patients with HIV infection.
