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
Clinical Trials
Related News

The Influence of GINkGo Biloba on the Pharmacokinetics of the UGT Substrate raltEgraviR (GINGER)

Phase 1
Completed
Conditions
Mild Cognitive Impairment
HIV Infections
Depression
Interventions
First Posted Date
2010-11-23
Last Posted Date
2020-11-30
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
18
Registration Number
NCT01246804
Locations
🇳🇱

CRCN, Radboud University Medical Centre, Nijmegen, Netherlands

Addition of Raltegravir to Established Antiretroviral Suppressive Therapy

Phase 4
Terminated
Conditions
HIV
Interventions
First Posted Date
2010-11-22
Last Posted Date
2016-12-23
Lead Sponsor
University of Miami
Target Recruit Count
15
Registration Number
NCT01245101
Locations
🇺🇸

Infectious Diseases Research Unit, University of Miami Miller School of Medicine, Miami, Florida, United States

TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir

First Posted Date
2010-11-16
Last Posted Date
2012-11-08
Lead Sponsor
Tibotec Pharmaceuticals, Ireland
Target Recruit Count
48
Registration Number
NCT01241773

Raltegravir Switch Study to Reduce Liver Fibrosis Progression in HIV-Hepatitis C Co-infection

Phase 2
Completed
Conditions
HIV
Hepatitis C
Liver Fibrosis
Interventions
First Posted Date
2010-11-01
Last Posted Date
2016-09-21
Lead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Target Recruit Count
9
Registration Number
NCT01231685
Locations
🇨🇦

Montreal Chest Institute, Montreal, Quebec, Canada

🇨🇦

Providence Health Care- St. Paul's Hospital, Vancouver, British Columbia, Canada

🇨🇦

University Health Network - Toronto General Hospital Division, Toronto, Ontario, Canada

A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults

Phase 3
Completed
Conditions
HIV Infections
Infection, Human Immunodeficiency Virus
Interventions
Drug: GSK1349572 Placebo
First Posted Date
2010-11-01
Last Posted Date
2022-03-15
Lead Sponsor
ViiV Healthcare
Target Recruit Count
724
Registration Number
NCT01231516
Locations
🇬🇧

GSK Investigational Site, Tooting, London, United Kingdom

A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

Phase 3
Completed
Conditions
Infection, Human Immunodeficiency Virus I
Interventions
Drug: GSK1349572 (dolutegravir)
Other: GSK1349572 Placebo
Other: ABC/3TC
Other: TDF/FTC
Other: raltegravir Placebo
First Posted Date
2010-10-25
Last Posted Date
2018-10-09
Lead Sponsor
ViiV Healthcare
Target Recruit Count
828
Registration Number
NCT01227824
Locations
🇬🇧

GSK Investigational Site, London, United Kingdom

Safety Study of Raltegravir in HIV/HCV Co-infected Patients

Phase 4
Withdrawn
Conditions
Hepatitis C
HIV
Interventions
Drug: Atazanavir/ritonavir
First Posted Date
2010-10-21
Last Posted Date
2015-06-03
Lead Sponsor
University Hospital, Bonn
Registration Number
NCT01225705
Locations
🇩🇪

Private Practice Dupke, Carganico, Baumgarten, Berlin, Germany

🇩🇪

Department of Internal Medicine I, Bonn University, Bonn, Germany

🇩🇪

University of Frankfurt, Frankfurt / Main, Germany

and more 5 locations

Measurement of Plasma and Intracellular Concentrations of Raltegravir

Not Applicable
Completed
Conditions
HIV
Interventions
First Posted Date
2010-10-05
Last Posted Date
2017-08-21
Lead Sponsor
University of Nebraska
Target Recruit Count
12
Registration Number
NCT01214486
Locations
🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)

Phase 4
Completed
Conditions
HIV
Interventions
First Posted Date
2010-10-05
Last Posted Date
2016-02-08
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
103
Registration Number
NCT01214759
Locations
🇺🇸

The University of Texas Health Science Center at Houston, Houston, Texas, United States

A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen)

Completed
Conditions
HIV-1 Infection
Interventions
First Posted Date
2010-10-04
Last Posted Date
2016-05-23
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
451
Registration Number
NCT01213316
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