Studien, an denen unsere Ärzt*innen beteiligt waren bzw. sind:

  1. A Phase 3b, open label, randomized, standard-ofcare control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1 (CROWN). (Protocol 221611, EutraCT-No. 2024-515070-28-00; NCT06694805; seit Oct/2025)
  2. A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared with a Licensed Inactivated Seasonal Influenza Vaccine in Adults >50 Years of Age. (Protocol mRNA-1010-P304; EutraCT No.: 2024-512323-36-00; NCT06602024; seit Sep 2024)
  3. Euro-HDV: Epidemiology and Clinical course in patients living with HIV and Hepatitis-B/D-coinfection. (NCT06264583; seit 2024)
  4. An Operationally Seamless Phase 2/3 Randomized,Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens (Protocol GS-US-621-6289). (EU CT-No. 2022-500929-33, seit 2024)
  5. A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption. (Protocol M19-965; EU CT: 2023-505900-53-00; Seit 05/2024)
  6. A Phase I/II, observer-blind, randomised, placebo-controlled, multi-country study to evaluate reactogenicity, safety, immune response, and efficacy of an HSV-targeted immunotherapy in healthy participants aged 18-40 years or in participants aged 18-60 years with recurrent genital herpes (Protocol 215336). (EutraCT-No. 2021-003586-359 seit 2024)
  7. A Phase 1/2, Observer-blind, Randomized, Placebo-controlled Multi-country Study to Assess Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age (Protocol 216156). EU-CT No. 2022-500883-37-00) seit 2023
  8. Target Trial für Effektivität der MVA-BN Vaccine gegen MPXV-Infektion bei Risikopersonen in Deutschland (TEMVAc), (DRKS-ID: DRKS00029638; 2022-2023)
  9. A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (Protocol V116-010), 2022-001785-35 ( EudraCT Number)Seit 2022.
  10. Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 2, Protocol 219288, EutraCT No2022-002268-53; seit Jan 2023)
  11. Sicherheit und Effektivität der MVA-BN Impfung gegen MPXV-Infektion bei Risikopersonen in Deutschland (SEMVAc). (DRKS-ID: DRKS00029638, seit Nov 2022-Jan 2023)
  12. A Phase 3, Randomized, Stratified, Observer-blind, Active-Controlled Study to Evaluate the Immunogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older. (EudraCT Number: 2022-001638-12; NCT05415462, 2022-2023)
  13. A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults >60 Years of Age (PortocolmRNA-1345-P301; EudraCT No 2021-005026-20; seit Sep 2022)
  14. A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (Protocol 003-00; EudraCT No 2022-000258-27; seit Aug 2022;)
  15. A Phase IIb, randomized, double-blind, parallel-group study to assess the efficacy, safety, tolerability, and resistance profile of GSK3640254 in combination with dolutegravir compared to dolutegravir plus lamivudine in HIV-1 infected, treatmentnaïve adults (Protocol 212483; EudrCT No 2021-000016-28; 11/2021-Jun 2023)
  16. A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents with Acute Hepatitis C Virus (HCV) Infection (Protocol M20-350; EudraCT No 2020-005777-27; seit 08/2021)
  17. A Randomised, Double-Blind Phase II Trial of Topical HDIT101 versus Placebo in Patients with Chronic Recurrent HSV-1 Infection and Orolabial Lesion (Protocol HTX101-03L; EudraCT No: 2020-000926-24; seit 11/2020)
  18. A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae (Protocol BTZ116577; EudraCT #2018-001780-23; seit 08/2020)
  19. A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants (Protocol:020-01; EudraCT #:2019-000590-23; seit 5/2021)
  20. Cohort on the incidence and prevalence of hepatitis C virus infection in HIV-positive and HIV-negative men who have sex with men in Germany (NoCO; Study reference: IN-DE-987-4637, 05/2019 – 07/2022)
  21. A Phase IIIb, open-label, hybrid type III trial evaluating implementation strategies for long-acting cabotegravir plus long-acting rilpivirine every two months in HIV-1 infected, virologically suppressed adults in select European healthcare settings. (Protocol:213199; EudraCT #: 2020-000424-19; seit 11/2020)
  22. Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment with GSK3228836 in Participants with Chronic Hepatitis B Virus (B-Clear); (Protocol 209668; 10/2020 – 06/2022)
  23. A Phase 3, International, Multi-center, Randomized, Double-blind, Placebocontrolled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the prevention of oral persistent infection with HPV Types 16, 18, 31, 33, 45, 52, or 58 in adult males, 20 to 45 years of age.(Protocol 049-00; EudraCT-Nr.: 2019-003236-23; seit 07/2020)
  24. A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (Protocol 018-00; EudraCT-Nr.: 2019-000587-23; 02/2020)
  25. A Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infected adults who are virologically suppressed (Protocol 208090-03; EudraCT-Nr.: 2018-000177-72; 10/2019 bis 12/2020)
  26. Eine randomisierte, doppelblinde, Double-Dummy Phase II-Studie mit HDIT101 als Einmalgabe versus Standardtherapie mit Valaciclovir bei Patienten mit chronisch-rezidivierender anogenitaler HSV-2-Infektion (Protocol HTX101-02G; EudraCT-Nr.: 2019-000880-26; 11/2019 bis 03/2021)
  27. A randomised, double-blind (Sponsor-unblinded), placebo-controlled, adaptive trial to investigate the antiviral effect, safety, tolerabilitiy and pharmacokinetics of GSK3640254 in HIV-1 infected treatment-naive adults. (Protocol 208132/01; EudraCT-Nr.: 2018-002208-15; 2019)
  28. A randomised study of interferon-free treatment for recently acquired hepatitis C in people who inject drugs and people with HIV coinfection (REACT), (Protocol NCT02625909; 09/2018 – 04/2020)
  29. Longitudinal Incidence Study In Subtype B-Prevalent Region Among Men Who Have Sex With Men at Risk for HIV Infection To Determine Feasibility of HIV Vaccine Efficacy Trials. (Protocol RV500/WRAIR#20535; Jul 2018 – März 2020)
  30. A Phase III, randomized, multicenter, parallel-group, noninferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV 1 infected adults who are virologically suppressed (Protocol 204862; EudraCT Nr.2015-004401-17; 4/2018 – 7/2022)
  31. A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults who are Virologically Suppressed. (Protocol 207966; EudraCT Nr. 2017-002946-62; Mar 2018 – Aug 2022)
  32. A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects who are Virologically Suppressed. (Protocol GS-US-380-4030, EudraCT No.2017-000308-17; Juli 2017 bis März 2019)
  33. A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 Infection. (Protocol GS-US-412-2055; EudraCT No. 2016-001399-31; seit Mai 2017)
  34. A Phase III, randomized, multicenter, parallel-group, noninferiority, open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus longacting rilpivirine from current INI- NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed. (Protocol 201585; EudraCT No. 2016-001647-39; seit Nov.2016)
  35. A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants. (Protocol 201584; EudraCT #: 2016-001646-25; Nov.2016 – May2022)
  36. A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 – 6 Infection and Human Immunodeficiency Virus-1(HIV-1) Co-Infection (EXPEDITION-2). (Protocol M14-730; EudraCT Nr.: 2015-005577-20, Juli 2016- Mai 2017)
  37. A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Boosted Atazanavir or Darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed, HIV-1Infected Adults. (Protocol GS-US-380-1878; EudraCT Nr: 2015-004011-20; Mai 2016 – Okt. 2018).
  38. A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults. (Protocol GS-US-380-1490; EudraCT Nr: 2015-003988-10; Apr. 2016 – Jun.2021)
  39. A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects who are Virologically Suppressed. (Protocol GS-US-380-1844; EudraCT Nr: 2015-004025-14, März 2016 – Okt. 2018)
  40. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I. (Protocol GS-US-292-1824; EudraCT Nr: 2015-002710-74, seit Feb.2016 -2018)
  41. A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects. (Protocol GS-US-292-1823; EudraCT Nr:2015-002711-15, Feb.2016 – 2018)
  42. A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs). (Protocol Nr.:MK-1439A-024; EudraCT NUMBER: 2014-005550-18; Okt. 2015 bis Dez. 2019)
  43. A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once daily fixed dose combination regimen versus a regimen consisting of darunavir/cobicistat fixed dose ombination coadministered with emtricitabine/tenofovir disoproxil fumarate fixed dose combination in antiretroviral treatment-naïve human immunodeficiency virus type 1 infected subjects. (Protocol TMC114FD2HTX3001; EudraCT Nr:2015-000754-38, Okt. 2015 – Apr.2018)
  44. A Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current PI or NNRTI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed. (Protokoll Nr.:GSK 201636; Jul 2015 – Sep 2018)
  45. A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100mg Once Daily, Each in Combination with TRUVADA or EPZICOM/KIVEXA, in Treatment-Naive HIV-1 Infected Subjects. (Protokoll: MK1439-018; EudraCT Nr.: 2014-001127-69, April 2015 bis Jun 2019)
  46. Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects with Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection. (Protokoll Nr.:GS-US-337-1612; EudraCT Nr.: 2014-004812-12, Juli 2015 – Jan 2016)
  47. A Phase IIIb, Randomized, Double-Blind Study to Evaluate Switching from a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects. (Protokoll-Nr. GS-US-366-1160, EudraCT-Nr. 2014-004779-21; Mai 2015 – NOV 2017)
  48. A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF). (Protokoll-Nr. GS-US-366-1216, EudraCT-NR.2014-004545-27; Mai 2015 – Nov 2017)
  49. Prospective clinical and pharmacoeconomic outcomes study of different first-line antiretroviral treatment strategies. -PROPHET-Studie-. (DAGNÄ e.V. -Deutsche Arbeitsgemeinschaft niedergelassener Ärzte in der Versorgung HIV-Infizierter e.V.; seit August 2014)
  50. A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Raltegravir (MK-0518) 1200 mg Once Daily Versus Raltegravir (MK-0518) 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects. (Protocol MK 518-292; EudraCT-Nr.: 2013-001939-47, Juni 2014 – Jun 2016)
  51. A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 plus TMC278 For the Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral regimen of GSK1265744 plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects.(Protocol 200056; EudraCT-Nr.: 2013-000783-29, Mai 2014 – Mai 2022)
  52. Prospektive Nicht-Interventionelle Studie zum Einsatz von Dolutegravir im Rahmen einer Antiretroviralen Kombinationstherapie im Praxisalltag in Deutschland (DOL-ART). (Studie 201067)
  53. Randomisierte multizentrische Studie mit parallelen Gruppen zur Untersuchung von Telaprevir (Incivo®) in Kombination mit Peginterferon Alfa-2a (Pegasys®) und Ribavirin (Copegus®) bei Patienten mit akuter HCV-1/HIV-1-Koinfektion. (Uniklinik Bonn; EudraCT-Nr.: 2012-001419-21, Sept. 2013- Sep. 2014)
  54. Safety and Efficacy of 240mg BI201335once daily in combination with Pegylated Interferon Alpha 2a and Ribavirinfor treatment of chronic Hepatitis C (HCV) genotype 1infection in HIV/HCV-co-infected patients. A multinational, randomized, parallel group, open-label trial. (Protokoll-Nr.: BI 1220.19; EudraCT-Nr.: 2010-021734-59)
  55. Prospective Observational Evaluation of the natural history and treatment of acute HCV in HIV-positive individuals – THE PROBE-C Study. (Uni Bonn; Leiter der Studie: Professor Jürgen K. Rockstroh; seit Oct. 2011)
  56. Eine nicht interventionelle Studie – HCV Protease-Inhibitor Resistenz-Analyse zur Erfassung von viralen Resistenzen bei Patienten mit chronischer Hepatitis C Genotyp 1 Infektion vor einer Triple-Therapie. (HCV-PIRB Studie). (Uni Frankfurt; Leiter der Studie: Professor Christoph Sarrazin; Jan 2013- Sep 2014)
  57. Eine nicht interventionelle Studie –HCV Protease-Inhibitor Resistenz-Analyse zur Erfassung und retrospektive Verlaufsuntersuchung von viralen Resistenzen bei Patienten mit fehlendem Ansprechen auf eine Triple-Therapie mit Telaprevir oder Boceprevir in Kombination mit PEG-Interferon Alfa und Ribavirin (HCV-PISA Studie). (Uni Frankfurt; Leiter der Studie: Professor Christoph Sarrazin; Sep 2011-Jan 2014)
  58. Aufbau einer Biobank zur Charakterisierung der viralen und genetischen Faktoren, welche für eine Ausheilung bzw. Chronifiezierung einer akuten Hepatitis C Infektion verantwortlich sind. (Uni Frankfurt; Leiter der Studie: Professor Christoph Sarrazin, seit Juni 2009)
  59. A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead Sponsored Trials in Subjects with Chronic Hepatitis C Infection.(Protokoll-Nr.: GS-US-248-0123; EudraCT-Nr.: 2011-000946-39)
  60. A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead- Sponsored Trials in Subjects with Chronic Hepatitis C Infection. (Protokoll-Nr. GS-US-248-0122; EudraCT Nr. 2011-000945-19, Mai 2014- Mai 2017)
  61. A phase 3, open-label study to investigate the efficacy and safety of Sofosbufir plus Ribavirin in chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects. (Protokoll-Nr. GS-US-334-0124; EudraCT-Nr. 2012-004154-28, März 2013- Mai 2014)
  62. A phase 3 open label study of safety and efficacy with BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in previously untreated HCV patients coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV).(Protokoll-Nr.: AI444043; EudraCT-Nr. 2011-003067-30, März 2012-Sep. 2013)
  63. A phase 3 open-label study to evaluate the safty, tolerability and efficacy of TMC435 plus PegIFN alpha-2a (Pegasys) and ribavirin (Copegus) triple therapy in chronic hepatitis C genotype-1 infected subjects who are co-infected sith human immundeficiency virus type 1 (HIV-1). (Protokoll-Nr.: TMC435-TiDP16-C212; EudraCT-Nr.: 2010-021337-31, seit November 2011– Mai 2013)
  64. An open-label, randomized study evaluating a switch from a regimen of two nucleoside reverse transcriptase inhibitors regimen plus any third agent to either a regimen to Atazanavir/Ritonavir once daily and Raltegravir twice daily or to a regimen of Atazanavir/Ritonavir once daily and Tenofovir/Emtricitabine once daily in virologically suppressed HIV-1 infected subjects with safty and/or tolerability issues on their present treatment regimen. (Protokoll-Nr.AI424402; EudraCT-Nr.:2009-017032-41; seit Dezember 2011-September 2013)
  65. A phase 3b, randomized, open-label study to evaluate the safety and efficacy of a single tablet regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate compared with a single tablet regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naïve adults.(Protokoll-Nr. GS-US-264-0110; EudraCT-Nr.2010-024007-27; Juni 2011- Juni 2013)
  66. A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects.(Protokoll-Nr. ING114467; EudraCT-Nr. 2010-020983-39; Feb 2011- Mär 2014)
  67. A multicenter, randomized, double-blind, comperative trial of Maraviroc + Darunavir/Ritonavir versus Emtricitabine/Tenofavir + Darunavir/Ritonavir for the treatment of antiretroviral- naïve HIV-infected patients with CCR5-TROPIC HIV-1. (Protokoll-Nr.: A4001095, EudraCT-Nr.: 2010-021785-30; Jan 2012-März 2014)
  68. A Phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1infected. (Protocoll-Nr.: ING113086, EudraCT-Nr.: 2009-017950-11; Okt. 2010-Mai 2014) antiretroviral therapy naïve adult subjects.
  69. A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults. (Protokoll-Nr.: GS-US-216-0114, EudraCT-Nr.:2009-016759-22; Juli 2010- Aug 2014)
  70. A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 versus Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir Disoproxil Fumirate in HIV-1 infected, antiretroviral treatment-naive adults. (Protokoll-Nr.: GS-US-236-0103; EudraCT-Nr.:2009-016758-42, Juli 2010- Jul 2014)
  71. A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naive adult subjects. (Protokoll-Nr.: ING112276, Phase IIb/ Aug 2009- Apr. 2014; 6 Patienten)
  72. Nichtinterventionelle Studie zur Qualitätssicherung der Kombinations- bzw. Tripeltherapie der chronischen Hepatitis C mit Peg-(40kd)-Interferon alfa-2a (Pegasys) bei Schwerpunkt-Gastroenterologen
  73. Nichtinterventionelle Studie zur Qualitätssicherung der Therapie der chronischen Hepatitis C mit Peg-(40kd)-Interferon alfa-2a (Pegasys) und Ribavirin (z.B. Copegus) bei Schwerpunkt-Gastroenterologen – ein Projekt im BNG, Teil II + III (ML 21645, Phase IV/ seit 2007)
  74. An open label, phase IIIb, randomized parallel group study to assass 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 BIDbased regimen (TRANXITION, Protokollnr.: BI 11001526, Phase IIIb/ Jan 2009 – Dez 2011; 19 Patienten)
  75. A Phase III, multicenter, double-blind, randomized, active comparator-controlled clinical trial to Study the safety and efficacy of once daily Raltegravir (MK-0518) versus twice daily Raltegravir, each in combination with TRUVADA , in treatment-naïve HIV infected patients (MK-0518-071 / Raltegravir-Studie, Phase III/ Mär 2009- Jan 2011; 8 Patienten)
  76. A Phase III, randomized, double-blind trial of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of abacavir and lamivudine in antiretroviral.naive HIV-1 infected subjects (Thrive, Protokoll Nr.. TMC-278-TiDP6-C215, Phase III/ August 2008- Februar 2012; 11 Patienten)
  77. Evaluation and documentation of switch to Invirase 500 mg treatment due to virologic failure and/or toxicity of previous antiretroviral therapy (Max Health, ML21417, Phase IV/ April 2008-März 2010; 18 Patienten)
  78. A Phase 4, open label, randomized, controlled Study to assess the effect on Lipid Profile of switching a stable HAART regimen offixed dose Abacavir/Lamivudine (Kivexa) plus Lopinavir/Ritonavir (Kaletra), to Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) plus Lopinavir/Ritonavir (Kaletra) in adult HIV-1 infected subjects with raised cholesterol (Rocket II, Protocoll-Nr.: GS-EU-164-0206, Phase IV/ Oktober 2008-August 2009; 6 Patienten)
  79. Randomised, double blind, double dummy, parallel group, active controlled trial to evaluate the antiviral efficacy of 400mg QD Nevirirapine Extended Release formulation in comparison to 200mg BID Nevirapine immediate release in combination with Truvada in antiretroviral therapy naive HIV-1infected patients (VERVE, Phase III/ Jan 2008- Nov 2011;14 Patienten)
  80. 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 (Protokoll-Nr.: 1100.1470 / ARTEN, Phase III/ Apr. 2007- Nov. 2010; 13 Patienten)
  81. 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. Study for HIV-1-infected antiretroviral-Naive Patients. (Protokoll-Nr.: 1182.71 / POTENT, Phase III)
  82. Study of Once-Daily vs. Twice-Daily Fosamprenavir plus Ritonavir, administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naïve HIV-1-infected Adult subjects.(Protokoll-Nr.: APV109141 / MERIT, Phase IV/2007-2008)
  83. Early Access of MK-0518 (Raltegravir) in Combination with an optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1-Infected Patients with limited to no Treatment Options (Protokoll-Nr.: MK-0518 / 023-00, EAP/ 2007-2008)
  84. Randomisierte , multi-zentrische, partiell placebokontrollierte Phase IIIb-Studie zum Vergleich der Wirksamkeit und Verträglichkeit von Amantadinsulfat versus Placebo zusätzlich zu einer Standardtherapie aus Peginterferon-alfa-2a (40KD) und Ribavirin bei nicht vorbehandelten Patienten mit chronischer Hepatitis C Virus-Genotyp-1-Infektion (Protokoll-Nr.: PRAMA, Phase III/2005-2006)
  85. Therapieoptimierung zur Überprüfung der Wirksamkeit und Verträglichkeit von PEG-Interferon alfa-2a in Kombination mit Ribavirin bei Patienten mit chronischer Hepatitis C und gleichzeitiger HIV-Infektion:Vergleich zu HCV-monoinfizierten Patienten und Vergleich von Patienten mit gleichzeitiger hochaktiver antiretroviraler Therapie (HAART) bzw. ohne gleichzeitige HAART, Phase IV/2003-2007
  86. Frühzeitiger Zugang zu TMC114 in Kombination für HIV-1 infizierte Patienten, bei denen mehrere ARV versagt haben. TMC114 in Kombination mit niedrig dosiertem Ritonavir und anderen ARV´s bei intensiv mit ARVs vorbehandelten HIV-1 infizierten Patienten mit begrenzten oder ausgeschöpften Behandlungsmöglichkeiten. (Protokoll-Nr.: TMC114-C226 / EAP/ April 2004-April 2007)
  87. Frühzeitiger Zugang zu TMC125 in Kombination mit anderen antiretroviralen Medikamenten für HIV-1 infizierte Patienten mit limitierten Behandlungsmöglichkeiten (Protokoll-Nr.: TMC125-C214 / EAP/Februar 2007-April 2009)
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