Value through Innovation27 July 2016

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Clinical Study Results

  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.14
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I/IIa
    Study Title

    Multiple-dose, open-label, randomized, safety and pharmacokinetic study of tipranavir in combination with low-dose ritonavir in HIV-infected pediatric patients

    Study Document
    Trial synopsis 1182.14 english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.12
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase III
    Study Title

    Randomized, open-label, comparative safety and efficacy study of tipranavir boosted with low-dose ritonavir (TPV/RTV) versus genotypically-defined protease inhibitor/ritonavir (PI/RTV) in multiple antiretroviral drug-experienced patients (RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir)

    Study Document
    Trial synopsis 1182.12_DS_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.127
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IV
    Study Title

    An observational study of HIV-1 infected adult patients treated with combination antiretroviral therapy including APTIVUS®

    Study Document
    Trial synopsis 1182.127_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.16
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    An Open Label Safety Study of Tipranavir Co-administered with low-dose Ritonavir (TPV/r) in patients with advanced HIV-1 infection and limited treatment options.

    Study Document
    Trial synopsis 1182.16_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.17
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II/III
    Study Title

    A long-term open-label rollover trial assessing the safety and tolerability of combination tipranavir and ritonavir use in HIV-1 infected patients

    Study Document
    Trial synopsis 1182.17_DS_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.2
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II
    Study Title

    Tipranavir disodium: An Open-Label Exploratory Study of Tipranavir and Ritonavir in Combination with One Nucleoside Reverse Transcriptase Inhibitor an One None-Nucleoside Reverse Transcriptase Inhibitor in Multiple Protease Inhibitor- Experienced HIV Patients.

    Study Document
    Trial synopsis 1182.2_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.33
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIb, III
    Study Title

    A randomised, open label, active controlled trial to evaluate the antiviral efficacy and safety of treatment with 500 mg Tipranavir plus 100 mg or 200 mg Ritonavir p.o. BID in combination with standard background regimen in comparison to 400 mg Lopinavir plus 100 mg Ritonavir p.o. BID in combination with standard background regimen in antiretroviral therapy naive patients for 48 with extension up to 156 weeks.

    Study Document
    Trial statement 1182.33_CO english
    Trial synopsis 1182.33_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.48
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase III
    Study Title

    Randomized, open-label, comparative safety and efficacy study of tipranavir boosted with low dose ritonavir (TPV/RTV) versus genotypically-defined protease inhibitor/ritonavir (PI/RTV) in multiple antiretroviral drug-experienced patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir)

    Study Document
    Trial synopsis 1182.48_PE_DR english
    Trial synopsis 1182.48_DS_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.51
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II
    Study Title

    An open label, randomized, parallel-group pharmacokinetics trial of tipranavir / ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV), or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced patients.

    Study Document
    Trial synopsis 1182.51_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.52
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIb
    Study Title

    Double-blind, randomized, dose optimization trial of three doses of tipranavir boosted with low dose ritonavir (TPV/RTV) in multiple antiretroviral drug-experienced subjects

    Study Document
    Trial synopsis 1182.52_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.67
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    Expanded Access Program France

    Study Document
    Trial synopsis 1182.67_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.68
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    An Open Label Safety Study of Tipranavir Co-administered with Low-dose Ritonavir (TPV/r) in Patients with Advanced HIV-1 Infection and Limited Treatment Options

    Study Document
    Trial synopsis 1182.68_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.70
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open label, non-randomized treatment protocol of Tipranavir co-administered with low-dose Ritonavir (TPV/r) in protease inhibitor-experienced patients with HIV-1 infection (the Tipranavir Expanded Access Program)

    Study Document
    Trial synopsis 1182.70_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.71
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    A prospective, randomized, open-labelled, multi-centre trial comparing the safety and efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to that of Prezista® (Darunavir, DRV/r) in three-class (NRTI, NNRTI, and PI) treatment-experienced patients with resistance to more than one PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

    Study Document
    Trial statement 1182.71_CO english
    Trial synopsis 1182.71_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.98
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (TPV/r) 500 mg/200 mg BID IN a racially and Gender diverse HIV-positive treatment experienced population with a pilot evaluation of therapeutic drug monitoring (TDM). The SPRING study is an open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy

    Study Document
    Trial statement 1182.98_CO english
    Trial synopsis 1182.98_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.99
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    Safety and efficacy study of TIpranavir boosted with low dose ritonavir (TPV/r) 500/200mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV Co-INfection, with a pilot evaluation of therapeutic drug monitoring (TDM). An Open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy (TICINO)

    Study Document
    Trial synopsis 1182.99_DR english
    Trial statement 1182.99_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.107
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIb
    Study Title

    A multicenter, randomized, open label, clinical trial to evaluate three doses of tipranavir boosted with ritonavir (500 mg/200 mg qd, 250 mg/100 mg bid and 500 mg/100 mg bid) by assessing the steady-state pharmacokinetics and short-term efficacy and safety in HIV-1 positive treatment naive patients

    Study Document
    Trial synopsis 1182.107_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.112
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional observational study of antiretroviral combination therapy with Aptivus® (tipranavir) and low-dose Norvir® (ritonavir) in HIV-infected patients

    Study Document
    Trial synopsis 1182.112_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.147
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IV
    Study Title

    PMS assessing the long-term efficacy and safety of tipranavir (Aptivus®) co-administered with low-dose ritonavir in treatment experienced patients with HIV-1 infection in the daily clinical practice.

    Study Document
    Trial synopsis 1182.147_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.109
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I/IIa
    Study Title

    Effect of steady state TPV/r 500 mg/200 mg on intracellular concentrations of zidovudine triphosphate and carbovir triphosphate

    Study Document
    Trial synopsis 1182.109_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.3
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II
    Study Title

    PNU-140690: A fourteen day dose-response study using a prototype self-emulsifying drug delivery sustem (SEDDS) formulation in treatment-naive HIV-1 infected patients.

    Study Document
    Trial synopsis 1182.3 english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.4
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II
    Study Title

    Tipranavir: An open-label, randomized study comparing combination therapy (Tipranavir and Ritonavir vs. Saquinavir and Ritonavir) used with two nucleoside reverse transcriptase inhibitors in single protease inhibitor-experienced HIV-1 patients

    Study Document
    Trial synopsis 1182.4_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.6
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I/IIa
    Study Title

    An open-label multinational study of the effects of three dose pairs of tipranavir/ritonavir (b.i.d.) on the pharmacokinetic characteristics of protocoldefined, baseline, triple drug nucleoside and non-nucleoside reverse transcriptaseinhibitor therapy in HIV-1 infected subjects

    Study Document
    Trial synopsis 1182.6 english
  • Alovudine - HIV Infections
    Clinical Study Number 1211.1
    Study Indication HIV Infections
    Product Alovudine
    Generic Name Alovudine
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, Double Blind, Placebo-controlled Dose Ranging Trial to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure

    Study Document
    Trial synopsis 1211.1 english
  • BILR 355 - HIV Infections
    Clinical Study Number 1188.2
    Study Indication HIV Infections
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    Randomized Placebo Controlled Dose Escalation Study of Safety, Tolerability Pharmacokinetics and Efficacy of BILR 355 BS in Healthy Volunteers and HIV-Infected Subjects

    Study Document
    Trial synopsis 1188.2_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1470
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IIIb
    Study Title

    Open-label, randomised clinical trial to compare the virological efficacy and safety of Atazanavir/Ritonavir on a background of Tenofovir and Emtricitabine vs. Nevirapine on same background, in HIV-1-infected patients who have received no previous antiretroviral treatment (ARTEN)

    Study Document
    Trial synopsis 1100.1470_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1535
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional observational study with Viramune® (nevirapine) and various drug combinations in the antiretroviral combination treatment of HIV-infected patients who have already been treated for approx. 10 years with Viramune®.

    Study Document
    Trial synopsis 1100.1535_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1526
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open label, phase IIIb, randomized parallel group study to assess the efficacy and safety of switching HIV-1 infected patients successfully treated with a Nevirapine IR based regimen to Nevirapine XR 400 mg QD or remaining on Nevirapine IR 200 mg BID based regimen

    Study Document
    Trial synopsis 1100.1526_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1492
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional observational study to investigate the long-term effect of Viramune® (nevirapine) with an initial combination of Viramune® and Truvada® (emtricitabine and tenofovir) in HIV-infected patients.

    Study Document
    Trial synopsis 1100.1492_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1486
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double blind, double dummy, parallel group, active controlled trial to evaluate the antiviral efficacy of 400 mg QD neVirapine Extended Release formulation in comparison to 200 mg BID neVirapinE immediate release in combination with Truvada® in antiretroviral therapy naive HIV-1 infected patients (VERxVE)

    Study Document
    Trial synopsis 1100.1486_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1452
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    A Case-Control Toxicogenomics Study to identify Unique Genetic Polymorphisms in Patients who have experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity within the First 8 weeks of Nevirapine Therapy

    Study Document
    Trial synopsis 1100.1452_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1461
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study of the impact on quality-of-life of a switch from a virologically effective regimen to a regimen containing a Non-Nucleoside Reverse Transcriptase Inhibitor (QUALVI) Nevirapine (Viramune®) clinical phase IV

    Study Document
    Trial synopsis 1100.1461_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1512
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    A Phase IV, open-label, randomized clinical trial to compare the virologic efficacy and safety of NEvirapine compared with Atazanavir, boosted with ritonavir, on a backbone of Truvada® (tenofovir and emtricitabine), in HIV 1-infected patients who have received no previous antiretroviral treatment (NEwArT)

    Study Document
    Trial synopsis 1100.1512_DS_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1305
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Collecting data in patients with HIV infection type 1 after switching from a protease inhibitor-containing therapy regimen and a viral load below detection level to a Viramune®-containing therapy regimen

    Study Document
    Trial synopsis 1100.1305_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1362
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    An open, randomised, multicentre, comparative trial, to evaluate the benefit of switching from a PI-based regimen to a Nevirapine-based regimen on the quality of life, patient adherence, patient’s perception of fat redistribution and metabolic changes, in HIV+ patients suffering from fat abnormalities.

    Study Document
    Trial synopsis 1100.1362_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1368
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase II
    Study Title

    A randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg when administered in combination with ZDV and 3TC for 48 weeks in antiretroviral naive paediatric patients

    Study Document
    Trial synopsis 1100.1368_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1426
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    An open-label, non-randomized, single-arm study, to investigate the mechanism(s) by which nevirapine increases plasma high density lipoprotein concentrations in HIV subjects treated with VIRAMUNE® tablets.

    Study Document
    Trial synopsis 1100.1426 english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1448
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    A pharmacokinetic study to assess nevirapine levels in HIV infected patients with impaired hepatic functions

    Study Document
    Trial synopsis 1100.1448_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1527
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Observational, non-interventional, post marketing study assessing the long-term   efficacy and safety of nevirapine therapy (combined with other ARV drugs) in   HIV-1 positive patients in the daily clinical practice

    Study Document
    Trial synopsis 1100.1527_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1518
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I/IIa
    Study Title

    An open-label, multiple dose, cross-over study to evaluate the steady-state pharmacokinetic parameters of nevirapine extended release tablets in HIV - 1 infected children, with an optional extension phase

    Study Document
    Trial synopsis 1100.1518_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1244
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE®), Abacavir, and Amprenavir in HIV-1 Infected NNRTI Naive Paitents

    Study Document
    Trial synopsis 1100.1244_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1245
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    An investigation of the potential pharmacokinetic interaction between Nevirapine (Viramune ®) and ethinyl estradiol/norethindrone [Ortho-Novum ® 1/35 (21 pack)] in HIV-1 infected women.

    Study Document
    Trial synopsis 1100.1245_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1258
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®)

    Study Document
    Trial synopsis 1100.1258_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1280
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    An Investigation of the Potential Pharrnacokinetic Interaction Between Nevirapine (VIRAMUNE®) and Saquinavir-sgc (Fortovase®) in HIV-1 Infected Patients

    Study Document
    Trial synopsis 1100.1280_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1286
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    A Multicenter, Randomized, Open-Label, Controlled Study of Nevirapine (VIRAMUNE®) and a Short Course of Prednisone to Determine the Safety and Effectiveness of this Strategy in Preventing Nevirapine (VIRAMUNE®) Associated Rash

    Study Document
    Trial synopsis 1100.1286_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1361
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Fluconazole (DIFLUCAN®)

    Study Document
    Trial synopsis 1100.1361_CO english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1395
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study with antiretroviral treated patients switching therapy because of therapeutic reasons from protease inhibitor- or NNRTI-containing regimens to nevirapine plus two nucleoside reverse transcriptase inhibitor (NRTI) regimens

    Study Document
    Trial synopsis 1100.1395 english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1402
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Long-term observational study in patients under anti-retroviral combination therapy who were switched from protease inhibitors or other NNRTI to Viramune® plus two nucleoside reverse transcriptase inhibitors (NRTI) for reason of therapy. (Long-Term Switch)

    Study Document
    Trial synopsis 1100.1402 english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1489
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase Ib
    Study Title

    Steady State Bioavailability of 2 different Nevirapine Extended Release formulations compared to steady state 400 mg of Viramune® (200 mg BID), in HIV-1 infected subjects, an open label, non randomised, multidose and multistage parallel group study (ERVIR)

    Study Document
    Trial synopsis 1100.1489 english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1287
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase III
    Study Title

    A prospective randomized open label clinical trial to determine the efficacy of nevirapine, compared with a combination of ZDV + 3TC, in decreasing the penpartum mother to child transmission of HIV. Women, who present after38 weeks gestation or are in labor after 35 weeks gestation and who are anti-retroviral  will be included.

    Study Document
    Trial synopsis 1100.1287 english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1536
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional observational study with Viramune® plus antiretroviralbackbone combination in HIV-infected women and male patients. Genderspecific evaluation of data.

    Study Document
    Trial synopsis 1100.1536_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1524
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional observational study with Viramune® (nevirapine) and various drug combinations in the antiretroviral combination treatment of HIV-infected patients

    Study Document
    Trial synopsis 1100.1524_DR english
  • VIRAMUNE ® - HIV Infections
    Clinical Study Number 1100.1550
    Study Indication HIV Infections
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study assessing the safety, efficacy and treatment adherence of nevirapine extended release (combined with other antiretroviral drugs) in HIV infected patients in daily clinical practice

    Study Document
    Trial synopsis 1100.1550_DR english
  • BILR 355 - HIV Infections
    Clinical Study Number 1188.31
    Study Indication HIV Infections
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomized, double-blind, placebo-controlled 7 day monotherapy Phase IIa study to evaluate the antiviral activity and safety of oral administered RTVboosted BILR 355 (75 mg and 150 mg twice daily) in HIV-1-infected, NNRTI-experienced patients, followed by 28 day combination therapy with Tipranavir or Lopinavir based HAART-regimen

    Study Document
    Trial statement 1188.31 english

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