| Isentress (raltegravir) / Merck (MSD) |
NCT01533259: Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients |
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| Completed | 3b | 48 | US | Stribild | Gilead Sciences | Acquired Immunodeficiency Syndrome, HIV Infections | 11/12 | 07/13 | | |
NCT00293267: A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2) |
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| Completed | 3 | 352 | Europe | raltegravir potassium, ISENTRESS™, Comparator: Placebo | Merck Sharp & Dohme LLC | HIV Infections | 08/07 | 05/11 | | |
NCT00293254: A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019) |
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| Completed | 3 | 351 | US | raltegravir potassium, ISENTRESS™, Comparator: placebo | Merck Sharp & Dohme LLC | HIV Infections | 10/07 | 05/11 | | |
CHEER, NCT00529243: Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects |
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| Completed | 3 | 52 | US | raltegravir, MK-0518, Isentress | Kaiser Permanente, Merck Sharp & Dohme LLC | HIV Infections | 07/08 | 09/09 | | |
EASIER, NCT00454337 / 2007-000162-20: Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load |
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| Completed | 3 | 170 | Europe | FTC/TDF + EFV or LPV/R +T20, FTC/TDF + EFV or LPV/R | French National Agency for Research on AIDS and Viral Hepatitis, Merck Sharp & Dohme LLC | HIV Infections | 09/08 | 09/08 | | |
| Terminated | 3 | 33 | US, Canada, Europe, RoW | tipranavir, ritonavir, Optimized Background Regimen (OBR), Nucleoside Reverse Transcriptase Inhibitors (NRTIs),, Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs),, Enfuvirtide,, Maraviroc,, Raltegravir | Boehringer Ingelheim | HIV Infections | 10/08 | | | |
NCT00443729: MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED) |
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| Terminated | 3 | 355 | US | Comparator: raltegravir, Comparator: placebo, Comparator: lopinavir (+) ritonavir | Merck Sharp & Dohme LLC | HIV Infection | 10/08 | 04/09 | | |
NCT00443703: MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED) |
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| Terminated | 3 | 352 | US | MK0518 (raltegravir), MK0518, raltegravir, Comparator: KALETRA™ (lopinavir (+) ritonavir ), KALETRA, Comparator: placebo | Merck Sharp & Dohme LLC | HIV Infection | 04/09 | 04/09 | | |
NCT00369941 / 2006-003109-23: A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT) |
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| Completed | 3 | 566 | US | MK-0518, raltegravir, Isentress®, Comparator: efavirenz, Sustiva®, Comparator: Truvada, emtricitabine/tenofovir disoproxil fumarate, Comparator: Placebo to MK-0518, Comparator: Placebo to efavirenz | Merck Sharp & Dohme LLC | HIV Infections | 05/09 | 02/12 | | |
PROGRESS, NCT00711009 / 2008-000881-22: Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL) |
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| Completed | 3 | 206 | US, Canada, Europe | lopinavir/ritonavir (LPV/r), ABT-378, lopinavir/ritonavir, LPV/r, Kaletra, emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), emtricitabine/tenofovir disoproxil fumarate, FTC/TDF, Truvada, raltegravir (RAL), raltegravir, RAL, Isentress, MK-0518 | Abbott, Merck Sharp & Dohme LLC | Human Immunodeficiency Virus Infection | 11/09 | 10/10 | | |
NCT00745823: A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071) |
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| Terminated | 3 | 775 | NA | Comparator: Raltegravir 400 mg b.i.d., ISENTRESS™, Experimental: Raltegravir 800 mg q.d., TRUVADA™ | Merck Sharp & Dohme LLC | HIV | 10/10 | 05/11 | | |
| Completed | 3 | 17 | Europe | Isentress®, Celsentri® | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Merck Sharp & Dohme LLC, Abbott | HIV Infections | 11/10 | 08/14 | | |
NCT00708162 / 2007-004225-26: Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir |
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| Completed | 3 | 724 | US, Canada, Europe, RoW | Elvitegravir, Vitekta®, GS-9137, Raltegravir, Isentress®, EVG placebo, RAL placebo, Background regimen | Gilead Sciences | HIV Infection | 12/10 | 04/15 | | |
NCT00562510: Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery |
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| Terminated | 3 | 20 | RoW | Raltegravir, Placebo | Pedro Cahn, Merck Sharp & Dohme LLC | HIV Infections | 12/10 | 12/10 | | |
NCT00764946: A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055) |
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| Completed | 3 | 209 | US | Comparator: raltegravir, ISENTRESS | Merck Sharp & Dohme LLC | Human Immunodeficiency Virus | 02/11 | 02/11 | | |
| Withdrawn | 3 | 0 | Canada | Various vaccines, VAQTA;, Pneumovax 23;, Td ADSORBED;, phiX174 bacteriophage | McGill University Health Centre/Research Institute of the McGill University Health Centre, Merck Sharp & Dohme LLC | HIV Infections | 08/11 | 08/11 | | |
| Completed | 3 | 828 | Canada, US, Europe, RoW | GSK1349572 (dolutegravir), raltegravir, GSK1349572 Placebo, ABC/3TC, TDF/FTC, raltegravir Placebo | ViiV Healthcare, Shionogi, GlaxoSmithKline | Infection, Human Immunodeficiency Virus I | 02/12 | 12/16 | | |
NCT00887653: Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy |
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| Completed | 3 | 20 | US | raltegravir, Isentress | The Miriam Hospital, Tufts Medical Center, Merck Sharp & Dohme LLC | HIV, Hyperlipidemia, Hypertriglyceridemia, HIV Infections | 06/12 | 04/14 | | |
| Completed | 3 | 149 | Europe | raltegravir (Isentress), Truvada® | Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux, Merck Sharp & Dohme LLC | HIV Infections | 08/12 | 12/12 | | |
VIKING-4, NCT01568892: Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir |
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| Completed | 3 | 30 | US | Dolutegravir 50 mg twice daily, GSK1349572, Dolutegravir placebo twice daily, GSK1349572 Placebo | ViiV Healthcare, Shionogi, GlaxoSmithKline | HIV Infections | 10/12 | 12/13 | | |
NCT00811954: Comparative Study of Three NNRTI-Sparing HAART Regimens |
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| Completed | 3 | 1814 | US | Emtricitabine/tenofovir disoproxil fumarate, TDF/FTC, Raltegravir, RAL, Darunavir, DRV, Ritonavir, RTV, Atazanavir, ATV | AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID), Bristol-Myers Squibb, Gilead Sciences, Merck Sharp & Dohme LLC, Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA | HIV Infection | 06/13 | 06/13 | | |
| Withdrawn | 3 | 0 | US | TDF/FTC Once-Daily + Raltegravir 400 mg Orally Twice-Daily, TDF/FTC Once-Daily + Raltegravir (Isentress) 400 mg Orally Twice-Daily, TDF/FTC + Efavirenz (Atripla) Once-Daily | Rush University Medical Center, Merck Sharp & Dohme LLC | HIV-1 Infections | 06/13 | 12/13 | | |
| Completed | 3 | 90 | Europe | raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine, darunavir; ritonavir; emtricitabine/tenofovir | ANRS, Emerging Infectious Diseases, Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer, Janssen-Cilag Ltd. | HIV-1 Infections | 07/13 | 12/13 | | |
NCT02247687: Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR) |
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| Terminated | 3 | 4 | Europe | Protease inhibitor, Prezista® / Norvir®, Isentress® (raltegravir), Counseling arm | ANRS, Emerging Infectious Diseases, Janssen-Cilag Ltd. | HIV-1 Infection, Treatment Resistant Disorders, Viremia | 09/15 | 09/15 | | |
| Completed | 3 | 27 | Europe | Raltegravir, Isentress | ANRS, Emerging Infectious Diseases, Merck Sharp & Dohme LLC | HIV-1 Infection, Chronic Renal Insufficiency | 11/15 | 11/15 | | |
onceMRK, NCT02131233 / 2013-001939-47: Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292) |
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| Completed | 3 | 802 | NA | Reformulated Raltegravir, Raltegravir, TRUVADA™, Placebo to Reformulated Raltegravir, Placebo to Raltegravir | Merck Sharp & Dohme LLC | HIV Infection | 12/15 | 12/16 | | |
REFLATE TB2, NCT02273765: Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis |
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| Completed | 3 | 460 | Europe, RoW | Tenofovir + lamivudine + raltegravir, Tenofovir + lamivudine + efavirenz | ANRS, Emerging Infectious Diseases, Merck Sharp & Dohme LLC, Ministry of Health, Brazil | HIV-1 Infection, Tuberculosis | 11/18 | 11/18 | | |
