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

Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

Not Applicable

Terminated

Conditions: HIV

Interventions: Drug: Raltegravir
Drug: Efavirenz

First Posted Date: 2011-02-10

Last Posted Date: 2019-10-31

Lead Sponsor: University of California, San Diego

Target Recruit Count: 2

Registration Number: NCT01293123

Locations: 🇺🇸
UCSD Antiviral Research Center, San Diego, California, United States

TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: TMC278
Drug: Raltegravir

First Posted Date: 2011-02-02

Last Posted Date: 2011-06-27

Lead Sponsor: Tibotec Pharmaceuticals, Ireland

Target Recruit Count: 24

Registration Number: NCT01288755

Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir

Phase 1

Completed

Conditions: HCV Infections
HIV Infections

Interventions: Drug: boceprevir
Drug: raltegravir

First Posted Date: 2011-02-02

Last Posted Date: 2020-12-01

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 24

Registration Number: NCT01288417

Locations: 🇳🇱
CRCN, Nijmegen, Netherlands

Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds

Phase 4

Completed

Conditions: HIV Infection
Hepatitis C

Interventions: Drug: Antiretroviral therapy (ART)
Drug: raltegravir
Drug: Emtricitabine and tenofovir disoproxil fumarate

First Posted Date: 2011-01-27

Last Posted Date: 2016-11-29

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 20

Registration Number: NCT01285050

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

Effects of Switching Efavirenz to Raltegravir on Vascular Function and Bone Markers in HIV-infected Patients

Phase 4

Completed

Conditions: HIV

Interventions: Drug: Tenofovir/emtricitabine/efavirenz
Drug: Tenofovir/emtricitabine
Drug: Raltegravir

First Posted Date: 2011-01-05

Last Posted Date: 2013-12-18

Lead Sponsor: Indiana University

Target Recruit Count: 30

Registration Number: NCT01270802

Locations: 🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States

Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.

Completed

Conditions: Integrase Inhibitors, HIV; HIV PROTEASE INHIB

Interventions: Drug: Raltegravir
Drug: Darunavir

First Posted Date: 2010-12-13

Last Posted Date: 2019-09-27

Lead Sponsor: Hospital Clinic of Barcelona

Target Recruit Count: 15

Registration Number: NCT01258374

Locations: 🇪🇸
Hospital Clinic, Barcelona, Spain

Addition of Raltegravir to Established Antiretroviral Suppressive Therapy

Phase 4

Terminated

Conditions: HIV

Interventions: Drug: Raltegravir

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

Phase 1

Completed

Conditions: Hepatitis C Virus

Interventions: Drug: TMC435
Drug: TMC435 + raltegravir
Drug: TMC435 + efavirenz
Drug: efavirenz
Drug: 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: Drug: Raltegravir
Drug: Ritonavir-boosted protease inhibitor

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
Drug: Raltegravir
Drug: Raltegravir Placebo
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

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy