Raltegravir

Generic Name: Raltegravir

Brand Names: Isentress

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₁FN_₆O_₅

CAS Number: 518048-05-0

Unique Ingredient Identifier: 22VKV8053U

Background: Raltegravir is an antiretroviral drug produced by Merck & Co., used to treat HIV infection. It received approval by the U.S. Food and Drug Administration (FDA) on 12 October 2007, the first of a new class of HIV drugs, the integrase inhibitors, to receive such approval.

Indication: For the treatment of HIV-1 infection in conjunction with other antiretrovirals.

Associated Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Associated Therapies: Post-exposure prophylaxis for occupational exposure to HIV therapy

Clinical Trials

Pilot Opened Trial in HIV-infected Patients Including an Investigational Marketed Product

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: raltegravir

First Posted Date: 2008-10-16

Last Posted Date: 2015-03-11

Lead Sponsor: Germans Trias i Pujol Hospital

Target Recruit Count: 57

Registration Number: NCT00773708

Locations: 🇪🇸
H.U. Germans Trias i Pujol, Badalona, Barcelona, Spain

Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers

Phase 1

Conditions: Healthy Volunteers

First Posted Date: 2008-10-15

Last Posted Date: 2010-03-31

Lead Sponsor: Hospital Clinic of Barcelona

Target Recruit Count: 14

Registration Number: NCT00772720

Locations: 🇪🇸
Hospital Clinic, Barcelona, Catalonia, Spain

Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: raltegravir and hyper-immune bovine colostrum
Drug: Hyper-immune Bovine Colostrum
Other: raltegravir placebo
Drug: Raltegravir
Other: Hyper-immune Bovine Colostrum placebo

First Posted Date: 2008-10-15

Last Posted Date: 2012-08-24

Lead Sponsor: Kirby Institute

Target Recruit Count: 75

Registration Number: NCT00772590

Raltegravir and Ezetimibe PK Study

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Ezetimibe and raltegravir
Drug: Raltegravir and ezetimibe

First Posted Date: 2008-10-15

Last Posted Date: 2010-08-16

Lead Sponsor: St Stephens Aids Trust

Target Recruit Count: 26

Registration Number: NCT00772551

Locations: 🇬🇧
Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom

Phase IIB Pilot of Atazanavir + Raltegravir

Phase 2

Terminated

Conditions: HIV

Interventions: Drug: Atazanavir
Drug: Raltegravir
Drug: Ritonavir
Drug: Tenofovir/Emtricitabine

First Posted Date: 2008-10-08

Last Posted Date: 2012-02-24

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 167

Registration Number: NCT00768989

Locations: 🇺🇸
Orlando Immunology Center, Orlando, Florida, United States
🇫🇷
Local Institution, Paris Cedex 20, France
🇺🇸
Yale University School Of Medicine, New Haven, Connecticut, United States

and more 7 locations

Abacavir Pharmacokinetic Study in the Absence/Presence of Darunavir/Ritonavir or Raltegravir in HIV-infected Subjects

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Abacavir
Drug: Darunavir/ritonavir
Drug: Raltegravir

First Posted Date: 2008-10-02

Last Posted Date: 2009-11-18

Lead Sponsor: St Stephens Aids Trust

Target Recruit Count: 29

Registration Number: NCT00765271

Locations: 🇬🇧
Chelsea and Westminster Hospital, London, United Kingdom

A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)

Phase 3

Completed

Conditions: Human Immunodeficiency Virus

First Posted Date: 2008-10-02

Last Posted Date: 2017-03-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 209

Registration Number: NCT00764946

Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: Raltegravir and truvada
Drug: Atazanavir, Norvir and Truvada

First Posted Date: 2008-09-30

Last Posted Date: 2015-01-05

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 33

Registration Number: NCT00762892

Locations: 🇺🇸
Thomas Street Clinic, Houston, Texas, United States

Safety Study of Lopinavir/Ritonavir With Raltegravir in HIV-infected Patients

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: lopinavir/ritonavir and raltegravir

First Posted Date: 2008-09-15

Last Posted Date: 2011-07-20

Lead Sponsor: Saint Michael's Medical Center

Target Recruit Count: 30

Registration Number: NCT00752037

Locations: 🇺🇸
Saint Michael's Medical Center, Newark, New Jersey, United States

BRAVO: Background Regimen of Raltegravir on Virologic Outcome

Completed

Conditions: HIV Infections

Interventions: Drug: raltegravir

First Posted Date: 2008-09-12

Last Posted Date: 2017-07-02

Lead Sponsor: Community Research Initiative of New England

Target Recruit Count: 442

Registration Number: NCT00751530

Locations: 🇺🇸
Dr. Nicholaos C. Bellos & Associates, Dallas, Texas, United States
🇺🇸
Light Source Medical, Los Angeles, California, United States
🇺🇸
Quest Clinical Research, San Francisco, California, United States

and more 12 locations

Drug Development Updates

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