Value through Innovation27 July 2016

Clinical Study Results

  • 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 ® - Acquired Immunodeficiency Syndrome
    Clinical Study Number 1100.1457
    Study Indication Acquired Immunodeficiency Syndrome
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Clinical and therapeutic evaluation of the infection by HIV/AIDS

    Study Document Trial synopsis 1100.1457_CO 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 ® - Acquired Immunodeficiency Syndrome
    Clinical Study Number 1100.1390
    Study Indication Acquired Immunodeficiency Syndrome
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    A pharmacokinetic study to evaluate the interaction between nevirapine (Viramune®) and methadone in HIV-1 infected, opioid-dependent adults on stable methadone maintenance therapy.

    Study Document Trial synopsis 1100.1390_CO english
  • VIRAMUNE ® - Acquired Immunodeficiency Syndrome
    Clinical Study Number 1100.1413
    Study Indication Acquired Immunodeficiency Syndrome
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase III
    Study Title

    Open-label Study evaluating the Resistance profile of Single dose Nevirapine(NVP) when combined with a 4 or 7 day course of Combivir® (ZDV)+3TC compared to Single dose Nevirapine for the Prevention of Mother to Child Transmission (pMTCT) of HIV - Treatment Options Preservation Study (T.O.P.S.)

    Study Document Trial synopsis 1100.1413_CO english
  • VIRAMUNE ® - Acquired Immunodeficiency Syndrome
    Clinical Study Number 1100.1414
    Study Indication Acquired Immunodeficiency Syndrome
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    An Open-Label Study of Nevirapine plus Combivir® (ZDV+3TC) in Women who have previously received a Nevirapine Regimen for the Prevention of Mother to Child Transmission (pMTCT) of HIV-1.

    Study Document Trial synopsis 1100.1414_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 ® - Renal Insufficiency
    Clinical Study Number 1100.1259
    Study Indication Renal Insufficiency
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    An Open-Label, Single-Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VIRAMUNE®)

    Study Document Trial synopsis 1100.1259_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 ® - Healthy
    Clinical Study Number 1100.1484
    Study Indication Healthy
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    A single-dose, 2-part, open-label, randomised, pharmacoscintigraphic investigation into the absorption of Nevirapine when released into different parts of the gastro-intestinal tract.

    Study Document Trial synopsis 1100.1484_CO english
  • VIRAMUNE ® - Healthy
    Clinical Study Number 1100.1485
    Study Indication Healthy
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of different oral Viramune extended release  formulations containing 300 mg or 400 mg compared to 200 mg or 400 mg as one or two 200 mg IR tablets following administration in healthy male volunteers - an open label,non-randomized, parallel group study (As per Amendment 1 of 23 May2006)

    Study Document Trial synopsis 1100.1485_CO 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 ® - Healthy
    Clinical Study Number 1100.1517
    Study Indication Healthy
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, non-randomised, single-dose, parallel-group study of pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily) and300 mg (3 x 100 mg tablets once daily) nevirapine extended release formulations compared to 200 mg VIRAMUNE® tablet as well as to 400 mg nevirapine extended release tablet following oral administration in healthy male volunteers

    Study Document Trial synopsis 1100.1517_CO english
  • VIRAMUNE ® - Healthy
    Clinical Study Number 1100.1531
    Study Indication Healthy
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomised, single dose, parallel-group Phase I study to investigate the pharmacokinetic properties of 200 mg Nevirapine extended release tablets when administered orally as 2x100 mg tablets or as 4x50 mg tablets in healthy male volunteers

    Study Document Trial synopsis 1100.1531 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

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.