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

Safety and Efficacy of Raltegravir+TDF+3TC in HBV/HIV Co-infected Patients

Not Applicable

Conditions: HBV Coinfection
HIV Infections

Interventions: Drug: raltegravir and tenofovir and lamivudine
Drug: efavirenz+tenofovir+lamivudine

First Posted Date: 2011-03-18

Last Posted Date: 2011-03-18

Lead Sponsor: Yunnan AIDS Care Center

Target Recruit Count: 60

Registration Number: NCT01318096

Locations: 🇨🇳
Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center, Kunming, Yunnan Provice, China

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

Pharmacokinetic Study of Raltegravir in Human Immunodeficiency Virus/Hepatitis C Virus (HIV/VHC) Coinfected Patients With Advanced (Child-Pugh C) Hepatic Cirrhosis

Phase 1

Completed

Conditions: Human Immunodeficiency Virus
Hepatitis C

Interventions: Drug: Raltegravir 400 mg/12hours

First Posted Date: 2011-02-04

Last Posted Date: 2013-02-01

Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Target Recruit Count: 10

Registration Number: NCT01289951

Locations: 🇪🇸
Hospital Universitario Ramón y Cajal., Madrid, Spain

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

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

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

Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of Head and Neck

Early Phase 1

Completed

Conditions: Head and Neck Cancer

Interventions: Drug: raltegravir and cisplatin

First Posted Date: 2011-01-12

Last Posted Date: 2015-06-18

Lead Sponsor: New Mexico Cancer Care Alliance

Target Recruit Count: 5

Registration Number: NCT01275183

Locations: 🇺🇸
University of New Mexico Cancer Center, Albuquerque, New Mexico, 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

Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.

Phase 4

Completed

Conditions: Cardiovascular Disease
HIV

Interventions: Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
Drug: raltegravir plus truvada

First Posted Date: 2010-12-13

Last Posted Date: 2015-01-12

Lead Sponsor: St Vincent's Hospital, Sydney

Target Recruit Count: 25

Registration Number: NCT01258439

Locations: 🇦🇺
Holdsworth House Medical Practice, Sydney, New South Wales, Australia
🇦🇺
St Vincent Hospital, Clinical Research Program, Sydney, New South Wales, Australia

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

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