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

The Raltegravir and Ribavirin Pharmacokinetics (PK) Study

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Ribavirin
Drug: Raltegravir

First Posted Date: 2009-09-23

Last Posted Date: 2019-10-11

Lead Sponsor: Imperial College London

Target Recruit Count: 14

Registration Number: NCT00982553

Locations: 🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom

Effect of Antacids on the Pharmacokinetics of Raltegravir

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: raltegravir
Drug: antacid

First Posted Date: 2009-07-23

Last Posted Date: 2017-06-28

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 17

Registration Number: NCT00944307

Locations: 🇺🇸
University of Colorado Denver, Aurora, Colorado, United States

Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Phase 4

Completed

Conditions: HIV
Osteopenia
Osteoporosis
HIV Infections

Interventions: Drug: Raltegravir

First Posted Date: 2009-07-15

Last Posted Date: 2015-06-12

Lead Sponsor: St Vincent's Hospital, Sydney

Target Recruit Count: 52

Registration Number: NCT00939874

Locations: 🇦🇺
Holdsworth Medical Practice, Sydney, New South Wales, Australia
🇦🇺
St Vincents Hospital, Sydney, New South Wales, Australia
🇦🇺
East Sydney Doctors, Sydney, New South Wales, Australia

and more 1 locations

A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: 2N(t)RTI
Drug: raltegravir
Drug: Ritonavir-boosted lopinavir

First Posted Date: 2009-07-02

Last Posted Date: 2019-09-04

Lead Sponsor: Kirby Institute

Target Recruit Count: 558

Registration Number: NCT00931463

Locations: 🇦🇺
Albion Street Centre, Sydney, New South Wales, Australia
🇲🇽
Instituto Nacional de Ciencias Medicas y Nutricion "Salvado Zubiran", Mexico City, Mexico
🇳🇬
Plateau State Specialist Hospital, Jos, Plateau State, Nigeria

and more 41 locations

Raltegravir in the Swiss HIV Cohort Study

Completed

Conditions: HIV Infection

Interventions: Drug: Raltegravir

First Posted Date: 2009-05-20

Last Posted Date: 2018-06-06

Lead Sponsor: University of Zurich

Target Recruit Count: 200

Registration Number: NCT00904644

Locations: 🇨🇭
University Hospital Zurich, Zurich, Switzerland

Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy

Phase 3

Completed

Conditions: Hypertriglyceridemia
HIV Infections
Hyperlipidemia
HIV

Interventions: Drug: raltegravir

First Posted Date: 2009-04-24

Last Posted Date: 2014-10-10

Lead Sponsor: The Miriam Hospital

Target Recruit Count: 20

Registration Number: NCT00887653

Locations: 🇺🇸
Miriam Hospital Immunology Clinic, Providence, Rhode Island, United States
🇺🇸
Tufts University, Boston, Massachusetts, United States

Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Drug: raltegravir
Drug: Study NNRTI
Drug: Study PI

First Posted Date: 2009-04-21

Last Posted Date: 2012-07-23

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 8

Registration Number: NCT00884793

Locations: 🇺🇸
San Francisco VA Medical Center (SFVAMC), San Francisco, California, United States
🇺🇸
San Francisco General Hospital, San Francisco, California, United States

Buprenorphine/Raltegravir Pharmacokinetic Interaction Study

Not Applicable

Completed

Conditions: HIV Infection
HIV Infections

Interventions: Drug: Raltegravir

First Posted Date: 2009-03-10

Last Posted Date: 2012-11-21

Lead Sponsor: Yale University

Target Recruit Count: 12

Registration Number: NCT00858962

Locations: 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States

Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

Completed

Conditions: HIV Infection

Interventions: Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Ritonavir
Drug: Atazanavir
Drug: Raltegravir
Drug: Darunavir

First Posted Date: 2009-02-26

Last Posted Date: 2016-01-13

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 334

Registration Number: NCT00851799

Locations: 🇺🇸
Harbor - UCLA Med. Ctr. CRS, Torrance, California, United States
🇺🇸
Northwestern University CRS (2701), Chicago, Illinois, United States
🇺🇸
Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston, Massachusetts, United States

and more 23 locations

Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

Phase 4

Completed

Conditions: Cardiovascular Disease
HIV Infections
HIV Infection
Inflammation

Interventions: Drug: Placebo
Drug: raltegravir

First Posted Date: 2009-02-13

Last Posted Date: 2018-12-12

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 56

Registration Number: NCT00843713

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Drug Development Updates

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