-
Protocol Number:
ML19712
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
03.09.2007
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).
-
Protocol Number:
ML18093
Product Name:
Viracept
[nelfinavir [Viracept]]
Date of Report:
01.04.2008
Phase:
IV
Open Label Expanded Access Program on safety measures during the treatment of HIV-1 positive pregnant patients with Viracept 1250 mg b.i.d. using the 625 mg tablet
-
Protocol Number:
ML18634
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
15.10.2008
Phase:
IV
Open-label, non randomized clinical trial of safety and tolerability of enfuviritide (Fuzeon®, HIV fusion inhibitor) in patients with advanced HIV1 infection
-
Protocol Number:
MV18220
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
02.04.2007
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.
-
Protocol Number:
ML18413
Product Name:
Invirase
[saquinavir]
Date of Report:
09.01.2008
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)
-
Protocol Number:
ML20837
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
19.03.2009
Phase:
IV
A multicenter open-label study evaluating the antiviral activity and safety of enfuvirtide (ENF) once daily (QD) or twice daily (BID) in triple-class experienced HIV-1 infected patients changing their therapy to a standard of care (SOC) regimen that includes initiating raltegravir (RAL) plus an optimized background (OB) antiviral regimen (AMICI study).
-
Protocol Number:
NV17658
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.08.2006
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.
-
Protocol Number:
NV16391
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.11.2005
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.
-
Protocol Number:
NV16390
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.11.2005
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.
-
Protocol Number:
MV18406
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.04.2008
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).
-
Protocol Number:
ML21287
Product Name:
enfuvirtide [Fuzeon]
[enfuvirtide]
Date of Report:
19.01.2012
Phase:
II
A randomized, open-label study evaluating the antiviral activity and safety of 3 month Fuzeon induction with an optimized background antiretroviral regimen versus OB alone, in Fuzeon-naive HIV-1 infected patients with virological failure.
-
Protocol Number:
ML18596
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.11.2006
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).
-
Protocol Number:
NP25607
Product Name:
Invirase
[saquinavir]
Date of Report:
To be Published
Phase:
I
A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients
-
Protocol Number:
ML19233
Product Name:
Fuzeon
[enfuvirtide [Fuzeon]]
Date of Report:
01.03.2008
Phase:
IV
A study to evaluate the effect of three different delivery mechanisms for Fuzeon on injection site reactions.
-
Protocol Number:
NV20911
Product Name:
saquinavir [Invirase]
[saquinavir]
Date of Report:
01.06.2010
Phase:
II
An open label study of the pharmacokinetics, safety and antiviral activity of Invirase boosted with ritonavir in HIV-infected infants and children 4 months to less than 6 years old.
-
Protocol Number:
ML17819
Product Name:
enfuvirtide
[enfuvirtide]
Date of Report:
01.07.2010
Phase:
IV
An open-label study to assess the safety and tolerability of Fuzeon in combination with a free choice of antiviral regimen in Thai patients with advanced HIV infection.
-
Protocol Number:
ML19326
Product Name:
saquinavir
[saquinavir]
Date of Report:
31.03.2009
Phase:
IV
An open-label study to evaluate the safety profile of the new 500mg film-coated tablet formulation of boosted saquinavir (Invirase 500mg) in HIV-1 infected patients
-
Protocol Number:
BP17921
Product Name:
saquinavir [Invirase]
[saquinavir]
Date of Report:
01.11.2009
Phase:
I
Effect of moderate liver impairment on the pharmacokinetics of saquinavir after administration of saquinavir/ritonavir 1000/100mg BID in HIV patients
-
Protocol Number:
ML19355
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
11.04.2007
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.
-
Protocol Number:
ML18243
Product Name:
enfuvirtide
[enfuvirtide]
Date of Report:
30.01.2009
Phase:
III
Evaluation of the viral burden decrease rate in HIV naïve patients treated with enfuvirtide, in comparison to the standard therapy
-
Protocol Number:
ML19849
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.06.2007
Phase:
IV
Fuzeon® Biojector® 2000 Open-Label Safety Study (BOSS).
-
Protocol Number:
WV16789
Product Name:
Viracept
[nelfinavir]
Date of Report:
01.07.2003
Phase:
III
Investigation of the gastrointestinal tolerability of a new Roche 625 mg formulation of Viracept (nelfinavir) in subjects with HIV-1 infection.
-
Protocol Number:
MV16721
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.01.2007
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.
-
Protocol Number:
ML25398
Product Name:
Invirase
[saquinavir]
Date of Report:
To be Published
Phase:
IV
Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
-
Protocol Number:
ML18242
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
26.03.2009
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 (The INDEED Study)
-
Protocol Number:
ML18018
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.03.2006
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).
-
Protocol Number:
NP17586
Product Name:
Fuzeon
[enfuvirtide]
Date of Report:
01.06.2006
Phase:
IV
Single-dose study of pharmacokinetics of enfuvirtide (FUZEON, T20/RO29-9800) in HIV-1 infected subjects with renal impairment.