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

Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection

Phase 4

Completed

Conditions: Hiv

Interventions: Drug: Raltegravir 400Mg Tab
Drug: Lamivudine 150Mg Tablet

First Posted Date: 2017-07-02

Last Posted Date: 2021-03-16

Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Target Recruit Count: 38

Registration Number: NCT03205566

Locations: 🇬🇧
Harrison Wing, Guy's Hospital, London, United Kingdom

QDISS Stud: QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient

Phase 2

Completed

Conditions: Virus-HIV

Interventions: Drug: Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)

First Posted Date: 2017-06-22

Last Posted Date: 2020-05-19

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 100

Registration Number: NCT03195452

Locations: 🇫🇷
Hopital St Louis, Paris, France
🇫🇷
CHR orléans, Orléans, France
🇫🇷
CH de Tourcoing, Tourcoing, France

and more 14 locations

Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME STUDY

Phase 3

Completed

Conditions: HIV

Interventions: Drug: Raltegravir
Drug: Placebo
Drug: Current ART

First Posted Date: 2017-01-24

Last Posted Date: 2025-04-13

Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Target Recruit Count: 61

Registration Number: NCT03029689

Locations: 🇪🇸
Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain

Study of the Effect of Atorvastatin for Reducing Aging-related Complication in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen

Phase 4

Completed

Conditions: Aging-related Inflammation in HIV-infected Patients

Interventions: Drug: PI-based regimen
Drug: Raltegravir
Drug: Atorvastatin

First Posted Date: 2015-10-16

Last Posted Date: 2020-10-29

Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Target Recruit Count: 42

Registration Number: NCT02577042

Locations: 🇪🇸
Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain

Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500

Phase 1

Completed

Conditions: HIV-infection

Interventions: Drug: VM-1500
Drug: Darunavir
Drug: Raltegravir
Drug: Ritonavir

First Posted Date: 2015-07-03

Last Posted Date: 2018-10-04

Lead Sponsor: Viriom

Target Recruit Count: 24

Registration Number: NCT02489487

Locations: 🇹🇭
Faculty of Medicine, Siriraj Hospital, Bangkok, Wanglang Road, Thailand

The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)

Phase 1

Completed

Conditions: HIV Infection

Interventions: Drug: Raltegravir 1200 mg
Drug: TUMS
Drug: Leader Antacid

First Posted Date: 2015-06-16

Last Posted Date: 2018-08-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 20

Registration Number: NCT02473367

Effects of Raltegravir Based Regimen on Platelet Reactivity, Platelet-monocyte Aggregation and Immune Activation

Phase 4

Completed

Conditions: HIV

Interventions: Drug: Continuation of own regimen
Drug: Raltegravir

First Posted Date: 2015-03-09

Last Posted Date: 2019-01-10

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 40

Registration Number: NCT02383355

Renal Integrase Study

Phase 4

Completed

Conditions: HIV

Interventions: Drug: Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat)
Drug: Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet
Drug: Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)

First Posted Date: 2015-01-30

Last Posted Date: 2017-06-27

Lead Sponsor: St Stephens Aids Trust

Target Recruit Count: 60

Registration Number: NCT02351908

Locations: 🇬🇧
SSAT Clinical Research Facility, London, United Kingdom

Research In Viral Eradication of HIV Reservoirs

Phase 2

Completed

Conditions: HIV

Interventions: Drug: Combination Antiretroviral Therapy (cART)
Drug: Raltegravir
Drug: Vorinostat
Biological: ChAdV63.HIVconsv (ChAd)
Biological: MVA.HIVconsv (MVA)

First Posted Date: 2015-01-12

Last Posted Date: 2023-10-23

Lead Sponsor: Imperial College London

Target Recruit Count: 60

Registration Number: NCT02336074

Locations: 🇬🇧
Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom
🇬🇧
Central and North West London NHS Foundation Trust, London, United Kingdom
🇬🇧
Chelsea and Westminster NHS Foundation Trust, London, United Kingdom

and more 3 locations

A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas

Conditions: HIV Infection

Interventions: Drug: raltegravir

First Posted Date: 2014-11-27

Last Posted Date: 2017-05-22

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 254

Registration Number: NCT02302950

Locations: 🇺🇸
Thomas Street Clinic, Houston, Texas, United States

Drug Development Updates

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