MedPath

Raltegravir

Generic Name
Raltegravir
Brand Names
Isentress
Drug Type
Small Molecule
Chemical Formula
C20H21FN6O5
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

RAL-eve Study: Raltegravir Substitution Study

Not Applicable
Completed
Conditions
HIV Infections
First Posted Date
2007-08-31
Last Posted Date
2011-11-02
Lead Sponsor
Stanford University
Target Recruit Count
14
Registration Number
NCT00523237
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Integrase Inhibitor (MK-0518) Viral Decay

Phase 2
Completed
Conditions
HIV Infections
Interventions
Drug: Placebo
Procedure: Leukopheresis
Procedure: Sigmoid Biopsy
First Posted Date
2007-08-27
Last Posted Date
2012-06-05
Lead Sponsor
Canadian Immunodeficiency Research Collaborative
Target Recruit Count
24
Registration Number
NCT00520897
Locations
🇨🇦

Maple Leaf Medical Clinic, Toronto, Ontario, Canada

DDI HV (ATV - Merck)

Phase 1
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2007-08-20
Last Posted Date
2010-02-04
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
22
Registration Number
NCT00518297
Locations
🇺🇸

Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey, United States

Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load

Phase 2
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2007-08-14
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
53
Registration Number
NCT00515827
Locations
🇺🇸

Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston, Massachusetts, United States

🇺🇸

Pitt CRS, Pittsburgh, Pennsylvania, United States

🇺🇸

MetroHealth CRS, Cleveland, Ohio, United States

and more 17 locations

Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents

First Posted Date
2007-06-12
Last Posted Date
2021-11-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
153
Registration Number
NCT00485264
Locations
🇺🇸

Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS, Chicago, Illinois, United States

🇺🇸

Children's Hosp. of Boston NICHD CRS, Boston, Massachusetts, United States

🇺🇸

Usc La Nichd Crs, Alhambra, California, United States

and more 39 locations

Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2007-04-13
Last Posted Date
2010-09-17
Lead Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Target Recruit Count
103
Registration Number
NCT00460382
Locations
🇫🇷

Hôpital Gustave Dron, Service Maladies Infectieuses, Tourcoing, France

MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)

Phase 3
Terminated
Conditions
HIV Infection
First Posted Date
2007-03-06
Last Posted Date
2017-03-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
355
Registration Number
NCT00443729

Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)

Conditions
HIV Infections
First Posted Date
2006-09-15
Last Posted Date
2016-04-22
Lead Sponsor
Merck Sharp & Dohme LLC
Registration Number
NCT00377065

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)

Phase 3
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2006-08-30
Last Posted Date
2017-03-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
566
Registration Number
NCT00369941

A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

Phase 3
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2006-02-17
Last Posted Date
2017-03-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
351
Registration Number
NCT00293254
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