Sexually Transmitted Diseases, Viral  >>  Isentress (raltegravir)  >>  Phase 3
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31 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
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

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)

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)

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

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

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
NCT00440271 / 2005-005264-86: SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC

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)

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)

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)

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)

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
SPIRAL, NCT00528892 / 2007-003401-27: Switching From PI to RALtegravir in HIV Stable Patients

Completed
3
282
Europe
Raltegravir, boosted PI
Hospital Clinic of Barcelona
HIV Infections
03/10
03/10
IntensVIH, NCT00935480 / 2009-014602-33: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients

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

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

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)

Completed
3
209
US
Comparator: raltegravir, ISENTRESS
Merck Sharp & Dohme LLC
Human Immunodeficiency Virus
02/11
02/11
SPARTA, NCT00874523 / ACTRN12609000179235: Raltegravir and Atazanavir Dosing Strategy Study

Completed
3
26
RoW
atazanavir plus raltegravir, Reyataz, Isentress
Kirby Institute, National Centre in HIV Epidemiology/The University of New South Wales (NCHECR/UNSW)
HIV Infection
07/11
07/11
RAG-1/2, NCT00785967: Immune Responses in Patients Treated With Raltegravir

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
SPRING-2, NCT01227824: A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

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

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
NCT01114425 / 2009-017742-31: Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection

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

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

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
SSAT036, NCT01195467: Atripla to Raltegravir Switch Study for CNS Toxicity

Completed
3
40
Europe
Truvada/Raltegravir, Truvada® = tenofovir + emtricitabine, Atripla® = tenofovir + emtricitabine + efavirenz, Raltegravir = isentress
St Stephens Aids Trust
HIV Infection
06/13
06/13
OPTIPRIM 2-ANRS, NCT01033760 / 2009-014742-28: Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

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
ANRS 143, NCT01066962 / 2009-015113-44: Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects

Completed
3
800
Europe
darunavir/ritonavir QD + raltegravir BID, darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
ANRS, Emerging Infectious Diseases, NEAT - European AIDS Treatment Network
HIV Infections
10/13
10/13
EARNEST, NCT00988039: Europe-Africa Research Network for Evaluation of Second-line Therapy

Completed
3
1277
RoW
Aluvia + 2NRTIs, Aluvia + raltegravir, Aluvia monotherapy
Justine Boles, European and Developing Countries Clinical Trials Partnership (EDCTP)
Human Immunodeficiency Virus, HIV
01/14
01/14
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)

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
NCT01825031: Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

Completed
3
1805
RoW
Raltegravir, Fluconazole, Azithromycin, Albendazole, Isoniazid, Ready to Use Supplementary Food, RUSF
Anna Griffiths, MRC, Department for International Development, United Kingdom, Wellcome Trust, Medical Research Council, PENTA Foundation
Human Immunodeficiency Virus
03/16
03/16
NCT01900106 / 2011-005973-21: A Prospective, Open-label Trial of Two ABC/3TC Based Regimens in Late Presenter naïve Patients (CD4 <200 Cells/µL)

Completed
3
47
Europe
abacavir/lamivudine + raltegravir, Kivexa, Isentress, abacavir/lamivudine + darunavir/ritonavir, Prezista, Norvir
University of Modena and Reggio Emilia
HIV Infection
12/17
12/17
NCT00729924: Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

Completed
2/3
40
US
Raltegravir, MK-0518
Vanderbilt University
HIV Infections
02/11
08/11
NCT01154673: Effects of Intensive cART During Acute/Early HIV Infection

Completed
2/3
32
Canada
raltegravir, Isentress, MK-0518, maraviroc, Celsentri, Selzentry, emtricitabine 200mg /tenofovir 300mg, Truvada, lopinavir 400 mg/ritonavir 100mg, Kaletra, Aluvia
University of Toronto, Unity Health Toronto, Maple Leaf Research
Acute HIV Infection
09/14
09/14

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