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

R5 Integrase Study in HIV-1 Naive Patients

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Drug: Raltegravir and Maraviroc in combination

First Posted Date: 2010-09-17

Last Posted Date: 2022-11-14

Lead Sponsor: University of Maryland, Baltimore

Target Recruit Count: 7

Registration Number: NCT01204905

Locations: 🇺🇸
University of Maryland, Institute of Human Virology, Baltimore, Maryland, United States

Efficacy and Safety of Raltegravir (RAL) in Treatment-experienced HIV-1 Infected Adult Chinese Patients

Phase 4

Conditions: HIV

Interventions: Drug: raltegravir

First Posted Date: 2010-09-14

Last Posted Date: 2010-09-14

Lead Sponsor: Shanghai Public Health Clinical Center

Target Recruit Count: 50

Registration Number: NCT01201239

Locations: 🇨🇳
Shanghai Public Health Clinical Center, Shanghai, Shanghai, China

A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells

Phase 4

Withdrawn

Conditions: HIV Infections
Acquired Immune Deficiency Syndrome

Interventions: Drug: Raltegravir plus Truvada
Drug: Atripla

First Posted Date: 2010-08-02

Last Posted Date: 2017-06-14

Lead Sponsor: Community Research Initiative of New England

Registration Number: NCT01173510

Pilot Study of Raltegravir Lipodystrophy IISP

Not Applicable

Conditions: HIV Infection

First Posted Date: 2010-07-16

Last Posted Date: 2012-05-18

Lead Sponsor: Southern California Institute for Research and Education

Target Recruit Count: 30

Registration Number: NCT01164605

Locations: 🇺🇸
VA Long Beach Healthcare System, Long Beach, California, United States

Pharmacokinetics of Low Dose Raltegravir

Phase 2

Completed

Conditions: HIV Infections

Interventions: Drug: raltegravir

First Posted Date: 2010-07-09

Last Posted Date: 2020-07-17

Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Target Recruit Count: 24

Registration Number: NCT01159132

Locations: 🇹🇭
HIV-NAT, Bangkok, Thailand

Effects of Intensive cART During Acute/Early HIV Infection

Phase 2

Completed

Conditions: Acute HIV Infection

Interventions: Drug: raltegravir
Drug: maraviroc
Drug: emtricitabine 200mg /tenofovir 300mg
Drug: lopinavir 400 mg/ritonavir 100mg

First Posted Date: 2010-07-01

Last Posted Date: 2016-04-05

Lead Sponsor: University of Toronto

Target Recruit Count: 32

Registration Number: NCT01154673

Locations: 🇨🇦
University of Toronto, Toronto, Ontario, Canada
🇨🇦
Maple Leaf Medical Clinic, Toronto, Ontario, Canada

Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection

Phase 4

Completed

Conditions: HIV Infection
Hepatitis C, Chronic

Interventions: Drug: Efavirenz
Drug: Raltegravir

First Posted Date: 2010-06-22

Last Posted Date: 2021-08-13

Lead Sponsor: University of Hawaii

Target Recruit Count: 80

Registration Number: NCT01147107

Locations: 🇻🇳
Viet Tiep General Hospital, Hai Phong, Vietnam
🇻🇳
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

Phase 4

Completed

Conditions: HIV Infections
HIV-1 Infection

Interventions: Drug: Raltegravir
Drug: Etravirine

First Posted Date: 2010-05-12

Last Posted Date: 2011-02-08

Lead Sponsor: Hospitales Universitarios Virgen del Rocío

Target Recruit Count: 16

Registration Number: NCT01121809

Locations: 🇪🇸
Hospitales Universitarios Virgen del Rocio, Sevilla, Spain

Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection

Phase 3

Completed

Conditions: HIV Infections

First Posted Date: 2010-05-03

Last Posted Date: 2017-02-23

Lead Sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Target Recruit Count: 149

Registration Number: NCT01114425

Locations: 🇫🇷
GERES, Paris, France

Safety and Efficacy Study Comparing Raltegravir to a Protease Inhibitor in Treatment-naïve, HIV/Hepatitis C Drug Users

Phase 4

Conditions: HIV Infections
Hepatitis C

Interventions: Drug: Atazanavir/Ritonavir
Drug: Raltegravir

First Posted Date: 2010-04-16

Last Posted Date: 2011-07-21

Lead Sponsor: St. James's Hospital, Ireland

Target Recruit Count: 40

Registration Number: NCT01105611

Locations: 🇮🇪
Mater Misericordiae University Hospital, Dublin, Ireland
🇮🇪
Department of Genitourinary Medicine and Infectious Diseases, St. James's Hospital, Dublin, Ireland

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