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

Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen

Not Applicable

Completed

Conditions: HIV-associated Neurocognitive Disorder
HIV
Neurotoxicity

Interventions: Drug: Raltegravir

First Posted Date: 2013-11-07

Last Posted Date: 2017-07-26

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 10

Registration Number: NCT01978743

Locations: 🇺🇸
Brigham and Women's hospital, Boston, Massachusetts, United States

Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

Phase 4

Completed

Conditions: HCV Coinfection
HIV Infection

Interventions: Drug: Raltegravir
Drug: Efavirenz

First Posted Date: 2013-07-16

Last Posted Date: 2017-07-25

Lead Sponsor: Juan Macías

Target Recruit Count: 45

Registration Number: NCT01900015

Locations: 🇪🇸
H.U. Valme, Seville, Spain
🇪🇸
Hospital Universitario Virgen del Rocío, Sevilla, Spain
🇪🇸
Hospital La Línea, La Línea de la Concepción, Cádiz, Spain

and more 7 locations

Raltegravir for HAM/TSP

Early Phase 1

Completed

Conditions: HTLV-I Infection

Interventions: Drug: Raltegravir

First Posted Date: 2013-06-04

Last Posted Date: 2023-03-30

Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Target Recruit Count: 19

Registration Number: NCT01867320

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection

Phase 2

Terminated

Conditions: HIV
Pregnancy

Interventions: Drug: Raltegravir
Drug: Lopinavir/Ritonavir

First Posted Date: 2013-05-16

Last Posted Date: 2024-10-15

Lead Sponsor: Fundação Bahiana de Infectologia

Target Recruit Count: 33

Registration Number: NCT01854762

Locations: 🇧🇷
Fundação Bahiana de Infectologia/SEI, Salvador, Bahia, Brazil

A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Raltegravir
Drug: Amlodipine

First Posted Date: 2013-04-26

Last Posted Date: 2014-09-29

Lead Sponsor: St Stephens Aids Trust

Target Recruit Count: 19

Registration Number: NCT01841593

Locations: 🇬🇧
St Stephen's AIDS Trust, London, United Kingdom

RAL+ATV/r in Comparison With TDF/FTC (or 3TC) +ATV/r in HIV Infected Patients

Phase 4

Conditions: Chronic Infection With HIV

Interventions: Drug: Ritonavir boosted Atazanavir
Drug: TDF/FTC (or 3TC)
Drug: Raltegravir

First Posted Date: 2013-04-11

Last Posted Date: 2017-01-24

Lead Sponsor: Pedro Cahn

Target Recruit Count: 50

Registration Number: NCT01829802

Locations: 🇦🇷
Fundacion Huesped, Buenos Aires, Argentina
🇦🇷
Dra Luna Norma, Cordoba, Argentina

Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants

Completed

Conditions: HIV Infections

Interventions: Drug: Raltegravir

First Posted Date: 2013-04-10

Last Posted Date: 2021-11-08

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 40

Registration Number: NCT01828073

Locations: 🇹🇭
Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Mai, Thailand
🇺🇸
St. Jude Children's Research Hospital CRS, Memphis, Tennessee, United States
🇺🇸
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, La Jolla, California, United States

and more 16 locations

Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

Phase 3

Completed

Conditions: Human Immunodeficiency Virus

Interventions: Dietary Supplement: Ready to Use Supplementary Food
Drug: Fluconazole
Drug: Raltegravir
Drug: Azithromycin
Drug: Albendazole
Drug: Isoniazid

First Posted Date: 2013-04-05

Last Posted Date: 2016-04-20

Lead Sponsor: Anna Griffiths, MRC

Target Recruit Count: 1805

Registration Number: NCT01825031

Locations: 🇺🇬
Joint Clinical Research Centre, Mbale, Mbale, Uganda
🇰🇪
Moi University Clinical Research Centre, Eldoret, Kenya
🇰🇪
KEMRI Wellcome Trust Research Programme, Kilifi, Kenya

and more 5 locations

Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Raltegravir
Drug: Faldaprevir

First Posted Date: 2013-02-07

Last Posted Date: 2015-08-03

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 25

Registration Number: NCT01785160

Locations: 🇩🇪
1220.65.1 Boehringer Ingelheim Investigational Site, Mannheim, Germany

Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Raltegravir

First Posted Date: 2013-01-31

Last Posted Date: 2021-11-05

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 52

Registration Number: NCT01780831

Locations: 🇿🇦
Umlazi CRS, Durban, KwaZulu-Natal, South Africa
🇹🇭
Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok, Bangkoknoi, Thailand
🇺🇸
Univ. of Florida Jacksonville NICHD CRS, Jacksonville, Florida, United States

and more 12 locations

Drug Development Updates

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