Value through Innovation27 July 2016

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_DS_DR 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 ® - Healthy
    Clinical Study Number 1182.10
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label study, in healthy adult volunteers, to determine the effects of single-dose and steady-state TPV/RTV500/200 mg on the steady-state pharmacokinetics of fluconazole100 mg qd (200 mg loading dose)

    Study Document Trial synopsis 1182.10_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.100
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, single-site, one-sequence cross-over study to assess the Relative Bioavailability of TPV/r 500 mg/200 mg at steady state whenTPV and RTV are administered as oral solutions vs. capsules in the fed and fasted state

    Study Document Trial synopsis 1182.100_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.101
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Evaluating the effects of Tipranavir (with ritonavir) capsule and liquid formulation on cytochrome P450 and P-glycoprotein activity using a biomarker cocktail in healthy human volunteers

    Study Document Trial synopsis 1182.101_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.102
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study to assess the effects of steady-state Efavirenz 600 mg QD (Sustiva®) on Tipranavir concentration whenTipranavir/Ritonavir are administered at doses 500 mg/200 mg BID to steady-state in healthy adult volunteers

    Study Document Trial synopsis 1182.102_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.104
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label one-sequence cross-over pharmacokinetic interaction study of steady-state tipranavir/ritonavir 500/200 mg with single-dose valaciclovir (500 mg) in healthy volunteers

    Study Document Trial synopsis 1182.104_CO 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 ® - Healthy
    Clinical Study Number 1182.11
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to determine the effects of single-dose and steady-state TPV/r(500 mg/200 mg) on the steady-state pharmacokinetics of Clarithromycin (BIAXIN ®) 500 mg bid and a preliminary assessment of the effects of a standard high-fat test meal on the steady-state pharmacokinetics of Tipranavir

    Study Document Trial synopsis 1182.11_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.117
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Effects of steady state Tipranavir/ritonavir or Darunavir/ritonavir or Ritonaviron platelet function, coagulation and fibrinolysis biomarkers in healthy subjects

    Study Document Trial synopsis 1182.117_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.124
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of two different oral solutions of 500 mg of tipranavir (new formulation vs. current formulation) administered in combination with 200 mg of ritonavir (oral solution) to healthy volunteers (an open-label, randomised,single-dose, two-way crossover study)

    Study Document Trial synopsis 1182.124 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.21
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Two-way Pharmacokinetic Interaction Study of Single-Dose Atorvastatin (LIPITOR®) with Tipranavir/Ritonavir (500 mg/200 mg) at Steady-State and the Effect of Antacid (MAALOX®) on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir(500 mg/200 mg) in Healthy Volunteers

    Study Document Trial synopsis 1182.21_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.22
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label, randomized, parallel group, multiple dose comparison of the effect of Tipranavir 750 mg and Ritonavir 200 mg or Tipranavir 500 mg and Ritonavir 100 mg, administered twice daily, on the pharmacokinetic characteristics of Norethindrone-Ethinyl Estradiol (Ortho®-1/35) administered as a single dose, in healthy female adult volunteers

    Study Document Trial synopsis 1182.22_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.24
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I multiple oral dose trial of Tipranavir 500 mg/Ritonavir200 mg dosed to steady-state followed by single-dose14C-radiolabeled Tipranavir co-administered with Tipranavir 500 mg/Ritonavir 200 mg to characterize the excretion balance and metabolite profile of 14C-radiolabeled Tipranavir in healthy male subjects

    Study Document Trial synopsis 1182.24_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.26
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study of multiple doses of tipranavir 500 mg and ritonavir 200 mg (twice daily) on the pharmacokinetic characteristics of methadone administered as a single dose in healthy volunteers.

    Study Document Trial synopsis 1182.26_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 ® - Hepatic Insufficiency
    Clinical Study Number 1182.32
    Study Indication Hepatic Insufficiency
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label study to determine the pharmacokinetics of single-dose and/or steady-state TPV/r 500/200 mg in subjects with mild and moderate hepatic insufficiency 

    Study Document Trial synopsis 1182.32 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.42
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, parallel group study of the drug-drug pharmacokinetic interaction of steady state tipranavir (SEDDS SEC) 500 mg and ritonavir (soft gelatin capsules) 100 mg or tipranavir750 mg and ritonavir 200 mg, both bid for 13.5 days with single dose didanosine 400 mg (delayed release capsule EC beadlets) in healthy volunteers

    Study Document Trial synopsis 1182.42 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.44
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to determine the effects of steady-state TPV/r (500 mg/200 mg) on the single-dose pharmacokinetics of rifabutin (MYCOBUTIN®) 150 mg, and the effects of single-dose rifabutin (150mg) on the steady-state pharmacokinetics ofTPV 500 mg (co-administered with RTV 200 mg)

    Study Document Trial synopsis 1182.44_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.45
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 500/200 mg of tipranavir/ritonavir paediatric solution compared to 500/200 mg of tipranavir/ritonavir capsules following oral administration and bioavailability of 500/200 mg tipranavir/ritonavir paediatric solution under the influence of food in healthy female and male subjects. An open-label, randomised,single-dose, three-way crossover trial.

    Study Document Trial synopsis 1182.45 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.46
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg r Tipranavir 750 mg and Ritonavir 200 mg twice a day for 11.5 dayson the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate 300 mg in Healthy Volunteers

    Study Document Trial synopsis 1182.46_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.5
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An Open-label, Parallel Group, Multiple-dose Investigation of the Pharmacokinetics of Tipranavir Soft Elastic Capsules SEDDS and Ritonavir Soft Gel Capsules and Their Effects on Cytochrome P-450 (3A4) Activity in Normal Healthy Volunteers

    Study Document Trial synopsis 1182.5_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.55
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    The pharmacodynamic/pharmacokinetic interaction of tipranavir and ritonavir with loperamide in healthy volunteers

    Study Document Trial synopsis 1182.55_CO english
  • APTIVUS ® - Hepatitis C
    Clinical Study Number 1182.59
    Study Indication Hepatitis C
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Open label, study to determine the pharmacokinetic interactions of steady state tipranavir/ritonavir (500/200 mg) and steady state ribavirin and pegylated Interferon alfa 2a in HIV negative, HCV infected subjects with mild hepatic impairment and the pharmacokinetic properties of tipranavir/ritonavir in HIV negative, HCV, HBV, hepatitis delta infected subjects or alcoholic cirrhosis subjects with moderate hepatic impairment

    Study Document Trial synopsis 1182.59 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.60
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of electrophysiological effects of tipranavir co-administered with ritonavir given b.i.d. for 2.5 days on the QT interval in healthy female and male subjects. A double-blind, randomised, placebo controlled, two-way crossover study with a positive control (moxifloxacin) and parallel dose roups

    Study Document Trial synopsis 1182.60_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.61
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to assess the pharmacokinetic interactions between steady-state TPV (500 mg) and single-dose and steady-state atazanavir (300 mg QD) in the presence of ritonavir (100 mg)

    Study Document Trial synopsis 1182.61_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.80
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label study with healthy adult volunteers to determine the effects of single-dose and steady-state TPV/r 500/200 mg on the steady-state pharmacokinetics of carbamazepine (200 mg twice daily)

    Study Document Trial synopsis 1182.80_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.83
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of single-dose oral tadalafil pharmacokinetic characteristics when simultaneously co-administered with single-doseand steady-state tipranavir/ritonavir 500 mg/200 mg to healthy male volunteers

    Study Document Trial synopsis 1182.83_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.84
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study in healthy adult volunteers to determine the effects of multiple-dose omeprazole (ANTRA® 40 mgqd) on the single-dose pharmacokinetics of tipranavir 500 mg coadministered with ritonavir 200 mg

    Study Document Trial synopsis 1182.84_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.93
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomized, single-dose, two-way crossover bioequivalence study assessing subjects receiving tipranavir 500 mg storedat controlled temperature (test product 30°C/70% RH) compared with tipranavir 500 mg stored at controlled refrigerated conditions (reference product 2-8°C), orally co-administered with ritonavir 200 mg under fasting conditions to healthy male and female volunteers

    Study Document Trial synopsis 1182.93_CO 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 ® - Healthy
    Clinical Study Number 1182.41
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Center, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effect of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg, Administered Daily on 3 Non-Consecutive Days and Twice Daily for 7 Days, on the Pharmacokinetic Characteristics of Efavirenz (Sustiva®) 600 mg a Day in Healthy Adult Volunteers

    Study Document Trial synopsis 1182.41_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
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.37
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Center, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effect of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg twice a day for 11.5 days on the Pharmacokinetic Characteristics of Zidovudine 300 mg in Healthy Volunteers

    Study Document Trial synopsis 1182.37_CO english

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