| Isentress (raltegravir) / Merck (MSD) |
NCT00958100: Raltegravir Switch for Toxicity or Adverse Events |
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| Completed | 2b | 40 | Europe | tenofovir emtricitabine raltegravir, Lamivudine Abacavir Raltegravir, Abacavir free | Catholic University of the Sacred Heart | HIV/AIDS, Antiretroviral Therapy, HIV Infections | 11/10 | 12/10 | | |
| Completed | 2b | 254 | US, Europe, RoW | BMS-663068 400 mg, BMS-663068 800 mg, BMS-663068 600 mg, BMS-663068 1200 mg, Raltegravir 400 mg, Tenofovir 300 mg, Ritonavir 100 mg, Atazanavir 300 mg | ViiV Healthcare, ViiV Healthcare UK (No. 4) Limited, Bristol-Myers Squibb International Corporation | Infection, Human Immunodeficiency Virus | 02/13 | 05/17 | | |
NCT01601626: Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV |
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| Terminated | 2b | 71 | RoW | Standard-dose Lopinavir/Ritonavir, LPV/RTV, LPV/r, Aluvia, Kaletra, Double-dose Lopinavir/Ritonavir, Raltegravir, RAL, Isentress, Isoniazid, INH, Pyridoxine, Vitamin B6, Pyrazinamide, PZA, Ethambutol, EMB, Rifabutin, RBT, Rifampin, RIF | AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID) | HIV Infection, Tuberculosis | 01/17 | 06/17 | | |
NCT00100048: A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED) |
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| Completed | 2 | 206 | US | Comparator: MK0518 monotherapy, Comparator: MK0518 combination therapy, Comparator: efavirenz, Comparator: tenofovir, Comparator: lamivudine, Placebo monotherapy | Merck Sharp & Dohme LLC | HIV Infections, Acquired Immunodeficiency Syndrome | 10/06 | 07/10 | | |
NCT00105157: Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED) |
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| Completed | 2 | 179 | US | Comparator: MK0518, MK0518, Placebo | Merck Sharp & Dohme LLC | HIV Infections, Acquired Immunodeficiency Syndrome | 10/06 | 07/09 | | |
| Completed | 2 | 103 | Europe | raltegravir potassium, Isentress, darunavir/ritonavir, Prezista, etravirine, TMC125, Optimized background regimen, OBT, enfuvirtide | French National Agency for Research on AIDS and Viral Hepatitis, Merck Sharp & Dohme LLC, Janssen-Cilag Tibotec | HIV Infections | 03/08 | 09/09 | | |
NCT00614458: MK-0518 Intensification And HDAC Inhibition In Depletion Of Resting CD4+ T Cell HIV Infection |
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| Terminated | 2 | 6 | US | Raltegravir; valproic acid, raltegravir (MK 0518), Valproic acid (VPA) (depakote) | University of North Carolina, Chapel Hill, National Institute of Allergy and Infectious Diseases (NIAID), Abbott, Merck Sharp & Dohme LLC | HIV Infections | 09/08 | 09/08 | | |
| Completed | 2 | 24 | Canada | Raltegravir (MK0518), Placebo, Leukopheresis, Sigmoid Biopsy | Canadian Immunodeficiency Research Collaborative, National Institutes of Health (NIH) | HIV Infections | 02/09 | 11/11 | | |
NCT00830804: Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults |
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| Completed | 2 | 113 | US | Raltegravir, RAL, Darunavir/Ritonavir, DRV/RTV | AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID) | HIV-1 Infections | 02/10 | 09/10 | | |
NCT00950859: A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir |
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| Completed | 2 | 51 | US, Canada, Europe | GSK1349572 (Cohort I), Dolutegravir, GSK1349572 (Cohort II) | ViiV Healthcare, GlaxoSmithKline | Infection, Human Immunodeficiency Virus | 11/10 | 01/15 | | |
NCT00822315: Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis |
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| Completed | 2 | 155 | Europe, RoW | efavirenz, raltegravir | ANRS, Emerging Infectious Diseases, Gilead Sciences, Merck Sharp & Dohme LLC | HIV Infections, Tuberculosis | 11/11 | 05/12 | | |
NCT00656175: Raltegravir Therapy for Women With HIV and Fat Accumulation |
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| Completed | 2 | 39 | US, Canada | raltegravir, Isentress | University of California, Los Angeles, Merck Sharp & Dohme LLC, Case Western Reserve University, Vanderbilt University, Tufts University, University Health Network, Toronto | HIV Infections, Lipodystrophy | 12/11 | 12/11 | | |
| Completed | 2 | 10 | Europe | Raltegravir | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal, Merck Sharp & Dohme LLC | HIV-1, HIV Infections | 12/11 | 12/11 | | |
NCT00654147: Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects |
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| Completed | 2 | 44 | US | Raltegravir & Lopinavir/ritonavir, Isentress, Kaletra, Raltegravir and emtricitabine/tenofovir, Truvada | Margaret A. Fischl, M.D. | HIV Infections | 01/12 | 01/12 | | |
ROCnRAL, NCT01420523: Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy |
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| Terminated | 2 | 48 | Europe | Raltegravir-Maraviroc, Isentress and Celsentri | ANRS, Emerging Infectious Diseases, Merck Sharp & Dohme LLC, ViiV Healthcare | Human Immunodeficiency Virus, Lipohypertrophy | 04/13 | 04/13 | | |
| Completed | 2 | 28 | US | DNA + HIV-rAd5 vaccine, ART intensification (raltegravir), Isentress, ART intensification (maraviroc), Selzentry, Celsentri | Robert L. Murphy, Objectif Recherche Vaccins SIDA, National Institute of Allergy and Infectious Diseases (NIAID), Pfizer, Merck Sharp & Dohme LLC | HIV Infection | 07/13 | 06/14 | | |
NCT00525733: Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01) |
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| Completed | 2 | 40 | US | darunavir 800 mg, prezista, FTC 200 mg/TDF 300mg, FTC/TDF, Maraviroc, selzentry, Raltegravir, isentress, Ritonavir 100 mg, norvir | Rockefeller University, Aaron Diamond AIDS Research Center, Merck Sharp & Dohme LLC, Pfizer | HIV Infections | 12/13 | 12/13 | | |
NCT01620736: Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load |
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| Withdrawn | 2 | 0 | NA | Raltegravir | Washington University School of Medicine, Merck Sharp & Dohme LLC | Human T-cell Leukemia Virus Type 1 Infection | 12/13 | 12/14 | | |
NCT01717287 / 2017-000050-18: A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248) |
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| Completed | 2 | 32 | NA | Raltegravir Film-coated Tablet, ISENTRESS®, MK-0518, Raltegravir Chewable Tablet, Other Anti-Retroviral Therapy | Merck Sharp & Dohme LLC, Covance | HIV Infection | 12/13 | 12/13 | | |
NCT01605890: Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients |
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| Completed | 2 | 30 | Europe | emtricitabine / tenofovir disoproxil fumarate / raltegravir . | ANRS, Emerging Infectious Diseases, Gilead Sciences, Merck Sharp & Dohme LLC | HIV-2 Infection | 12/15 | 12/15 | | |
| Completed | 2 | 11 | Europe | Raltegravir | Arbeitsgemeinschaft medikamentoese Tumortherapie, Merck Sharp & Dohme LLC | HIV Infections | 12/15 | 12/15 | | |
NCT01231685: Raltegravir Switch Study to Reduce Liver Fibrosis Progression in HIV-Hepatitis C Co-infection |
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| Completed | 2 | 9 | Canada | Raltegravir, Isentress, MK-0518, RGV, Ritonavir-boosted protease inhibitor, Kaletra, Lopinavir-ritonavir, Atazanavir-ritonavir, Reyataz-norvir, Darunavir-ritonavir, Presista-norvir | McGill University Health Centre/Research Institute of the McGill University Health Centre, Merck Sharp & Dohme LLC, CIHR Canadian HIV Trials Network | HIV, Hepatitis C, Liver Fibrosis | 03/16 | 09/16 | | |
| Completed | 2 | 83 | Europe | Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy, raltegravir (Isentress®) | ANRS, Emerging Infectious Diseases | HIV-1 Infection, PREGNANCY | 01/17 | 04/17 | | |
RANIA, NCT02116660 / 2013-001637-40: Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) |
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| Terminated | 2 | 11 | NA | Raltegravir (MK-0518), Nevirapine, Lamivudine, Tenofovir, Emtricitabine, Lopinavir, Ritonavir, Atazanavir, Darunavir | Merck Sharp & Dohme LLC | HIV Infections | 07/17 | 07/17 | | |
NCT01565889: Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients. |
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| Completed | 1/2 | 52 | US | SOF, Sovaldi®, GS-7977, PSI-7977, EFV/FTC/TDF, Atripla®, EFV, Sustiva®, ZDV/3TC, Combivir®, ATV, Ritonavir, FTC/TDF, Truvada®, DRV, RAL, PEG, Pegasys®, RBV, Ribasphere® | Gilead Sciences | Hepatitis C, HIV | 08/13 | 11/13 | | |
